INCY Incyte Corporation

86.79
-3.63  -4%
Previous Close 90.42
Open 90.76
52 Week Low 62.48
52 Week High 110.365
Market Cap $18,980,893,587
Shares 218,699,085
Float 185,273,531
Enterprise Value $17,453,160,587
Volume 3,301,207
Av. Daily Volume 1,183,190
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Upcoming Catalysts

Drug Stage Catalyst Date
Jakafi
Myelofibrosis
Approved
Approved
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Parsaclisib INCB50465 (CITADEL-205)
Mantle cell lymphoma
Phase 2
Phase 2
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Parsaclisib INCB50465 (CITADEL-203)
Follicular lymphoma
Phase 2
Phase 2
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INCB86550
Solid Tumors
Phase 1
Phase 1
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Ruxolitinib (Jakafi)
COVID-19 associated cytokine storm
Phase 3
Phase 3
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Ruxolitinib - TRuE-AD1
Atopic dermatitis
NDA Filing
NDA Filing
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Parsaclisib INCB50465 (CITADEL-204)
Marginal zone lymphoma
Phase 2
Phase 2
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INCB54828 Pemigatinib (FIGHT-201)
Bladder cancer
Phase 2
Phase 2
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Ruxolitinib - TRuE-V
Vitiligo
Phase 3
Phase 3
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Baricitinib
Systemic lupus erythematosus (SLE)
Phase 3
Phase 3
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Baricitinib
Alopecia Areata
Phase 3
Phase 3
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Itacitinib - GRAVITAS-309
Chronic Graft-Versus-Host Disease
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Retifanlimab INCMGA0012
Anal cancer
Phase 2
Phase 2
Phase 2 data noted objective response rate of 14% and disease control rate of 49% - September 18, 2020.
Baricitinib and remdesivir (ACTT-2)
COVID-19
Phase 3
Phase 3
Phase 3 trial met primary endpoint - September 14, 2020. One-day reduction in median recovery time.
INCB001158
Solid tumors
Phase 1/2
Phase 1/2
Phase 1/2 data at ESMO 2019 noted - 7% PR rate.
Ruxolitinib - REACH 2
Steroid-refractory acute GVHD (Graft versus host disease)
Phase 3
Phase 3
Phase 3 data met primary endpoint - October 16, 2019.
Pelareorep and retifanlimab (INCMGA00012) - IRENE
Triple-negative breast cancer.
Phase 2
Phase 2
Phase 2 trial initiation announced August 26, 2020.
Tafasitamab (MOR208/XmAb5574)
Relapsed or refractory diffuse large B cell lymphoma
Approved
Approved
FDA Approval announced July 31, 2020.
Ruxolitinib (RESET)
Essential thrombocythemia
Phase 3
Phase 3
Recruitment has been discontinued - February 13, 2020.
Ruxolitinib - REACH 3
Steroid-refractory chronic GVHD (Graft versus host disease)
Phase 3
Phase 3
Phase 3 trial met primary and secondary endpoints - July 23, 2020.
Capmatinib
Non-small cell lung cancer
Approved
Approved
FDA Approval announced May 6, 2020.
Pemigatinib
Cholangiocarcinoma
Approved
Approved
FDA Approval announced April 17, 2020.
Itacitinib - GRAVITAS-301
Treatment-naïve acute GVHD
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - January 2, 2020.
Pemigatinib (FIGHT-302)
Cholangiocarcinoma - first line
Phase 3
Phase 3
Phase 3 initiation of dosing announced June 4, 2019.
Baricitinib
Atopic dermatitis
Phase 3
Phase 3
Phase 3 BREEZE-AD5 trial met primary endpoint - January 30, 2020.
Epacadostat with pembrolizumab (ECHO-302)
Renal cancer
Phase 3
Phase 3
Phase 3 enrollment to be discontinued.
Ruxolitinib
Graft versus host disease
Approved
Approved
FDA approval announced May 24, 2019.
INCB50465 (CITADEL-202)
Diffuse large B cell lymphoma
Phase 2
Phase 2
Phase 2 trial to be discontinued - noted June 21, 2018.
Baricitinib
Rheumatoid arthritis
Approved
Approved
CRL received April 14, 2017. NDA resubmitted. Approval announced for low dose only - June 1, 2018.
Epacadostat with Keytruda - ECHO-301
Cancer - first-line metastatic melanoma.
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - noted April 6, 2018.
Jakafi (ruxolitinib) (RELIEF)
Disease-related symptoms in patients with Polycythemia Vera
Phase 3
Phase 3
Endpoint not met, mid-2014
Ruxolitinib
Colorectal cancer
Phase 2
Phase 2
Phase 2 trial stopped January 2016 due to lack of efficacy
Ruxolitinib - JANUS 1 and JANUS 2
Cancer - Pancreatic
Phase 3
Phase 3
Phase 3 trial discontinued due to lack of efficacy
Jakafi (ruxolitinib) (RESPONSE)
Polycythemia Vera
Approved
Approved
Approved December 4, 2014.

Latest News

  1. INDIANAPOLIS, Sept. 18, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

    This opinion marks the first step toward European regulatory approval for baricitinib (marketed as OLUMIANT®) for patients with AD. If approved, baricitinib would become the first JAK inhibitor indicated to help treat patients with AD. The CHMP opinion is now referred for action to the European Commission, which grants approval in the European Union. A final decision…

    INDIANAPOLIS, Sept. 18, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

    This opinion marks the first step toward European regulatory approval for baricitinib (marketed as OLUMIANT®) for patients with AD. If approved, baricitinib would become the first JAK inhibitor indicated to help treat patients with AD. The CHMP opinion is now referred for action to the European Commission, which grants approval in the European Union. A final decision is expected from the European Commission in the next one-two months.

    "Due to the limited treatment options currently available for adult patients with AD, we're excited to further explore baricitinib's potential benefit for patients," said Patrik Jonsson, Lilly senior vice president and president of Lilly Bio-Medicines. "At Lilly, we aspire to elevate treatment standards for patients with dermatologic conditions. Today's CHMP opinion brings us closer to providing a new medicine for adults living with AD in Europe."

    The positive opinion was based on Lilly's Phase 3 BREEZE-AD clinical development program for baricitinib evaluating the medicine's potential to treat AD including BREEZE-AD1 and BREEZE-AD2, monotherapy studies investigating the efficacy and safety of baricitinib in moderate to severe AD patients; BREEZE-AD4, a study evaluating the efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate to severe AD who have failed or who are intolerant to, or have contraindications to cyclosporine; and BREEZE-AD7, a study evaluating the efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate to severe AD.

    "Patients living with AD face difficulties on a daily basis, and this CHMP opinion marks an important milestone in providing adult AD patients with a new potential treatment option," said Prof. Thomas Bieber, M.D., Ph.D., M.D.R.A., Professor of Dermatology and Allergy, University Hospital in Bonn, Germany.

    OLUMIANT® is already approved in more than 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis (RA).

    Lilly has exclusive worldwide development and commercialization rights for baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases under a license and collaboration agreement with Incyte.

    Information on the previously approved EU OLUMIANT indication (Rheumatoid Arthritis) can be found here.

    Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients

    OLUMIANT® (baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

    IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) TABLETS 

    WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS

    SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:

    • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.
    • Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
    • Bacterial, viral, and other infections due to opportunistic pathogens.

    Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.

    Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

    MALIGNANCIES: Lymphoma and other malignancies have been observed in patients treated with Olumiant.

    THROMBOSIS: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.

    WARNINGS AND PRECAUTIONS

    SERIOUS INFECTIONS: The most common serious infections reported with Olumiant included pneumonia, herpes zoster and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than local disease and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients:

    • with chronic or recurrent infection
    • who have been exposed to TB
    • with a history of a serious or an opportunistic infection
    • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
    • with underlying conditions that may predispose them to infection.

    Closely monitor patients for infections during and after Olumiant treatment. Interrupt Olumiant if a patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume Olumiant until the infection is controlled.

    Tuberculosis Before initiating Olumiant evaluate and test patients for latent or active infection and treat patients with latent TB with standard antimycobacterial therapy. Olumiant should not be given to patients with active TB. Consider anti-TB therapy prior to initiating Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Monitor patients for TB during Olumiant treatment.

    Viral Reactivation – Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves.

    The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.

    MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS: Malignancies were observed in Olumiant clinical studies. Consider the risks and benefits of Olumiant prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing Olumiant in patients who develop a malignancy. NMSCs were reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

    THROMBOSIS:  Thrombosis, including DVT and PE, has been observed at an increased incidence in Olumiant-treated patients compared to placebo. In addition, arterial thrombosis events in the extremities have been reported in clinical studies with Olumiant. Many of these adverse events were serious and some resulted in death. There was no clear relationship between platelet count elevations and thrombotic events. Use Olumiant with caution in patients who may be at increased risk of thrombosis. If clinical features of DVT/PE or arterial thrombosis occur, evaluate patients promptly and treat appropriately.

    GASTROINTESTINAL PERFORATIONS: Gastrointestinal perforations have been reported in Olumiant clinical studies, although the role of JAK inhibition in these events is not known. Use Olumiant with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.

    LABORATORY ABNORMALITIES:

    Neutropenia – Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3) compared to placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

    Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

    Anemia – Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

    Liver Enzyme Elevations – Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of ALT ≥5x upper limit of normal (ULN) and increases of AST ≥10x ULN were observed in patients in Olumiant clinical trials.

    Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.

    Lipid Elevations – Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation. Manage patients according to clinical guidelines for the management of hyperlipidemia.

    VACCINATIONSAvoid use of live vaccines with Olumiant. Update immunizations in agreement with current immunization guidelines prior to initiating Olumiant therapy.

    HYPERSENSITIVITY: Reactions such as angioedema, urticaria, and rash that may reflect drug sensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.

    ADVERSE REACTIONS

    Most common adverse reactions include: upper respiratory tract infections (16.3%, 11.7%), nausea (2.7%, 1.6%), herpes simplex (0.8%, 0.7%) and herpes zoster (1.0%, 0.4%) for Olumiant 2 mg and placebo, respectively.

    USE IN SPECIFIC POPULATIONS

    PREGNANCY AND LACTATION: No information is available to support the use of Olumiant in pregnancy or lactation. Advise women not to breastfeed during treatment with Olumiant.

    HEPATIC AND RENAL IMPAIRMENT: Olumiant is not recommended in patients with severe hepatic impairment or in patients with severe renal impairment.

    Please click to access full Prescribing Information, including Boxed Warning about Serious infections, Malignancies, and Thrombosis, and Medication Guide.

    BA HCP ISI 09JUL2020

    About OLUMIANT®

    OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.1 There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.2 OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.1 OLUMIANT is approved in more than 70 countries. OLUMIANT is developed by Lilly under license from Incyte Corporation.

    About Atopic Dermatitis

    Atopic dermatitis (AD), or atopic eczema, is a chronic, relapsing skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.3 AD is a heterogeneous disease both biologically and clinically, but may be characterized by chronic symptoms of itch, redness and skin damage that are often punctuated with episodic, sometimes unpredictable, flares or exacerbations.4,5 AD affects approximately one-three percent of adults worldwide.

    Moderate to severe AD is characterized by intense itching, resulting in visibly damaged skin.7 Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.8

    About Lilly in Dermatology

    By following the science through unchartered territory, we continue Lilly's legacy of delivering innovative medicines that address unmet needs and have significant impacts on people's lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people's lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.

    About Eli Lilly and Company

    Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom.

    About Incyte 

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    P-LLY

    This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a treatment for patients with atopic dermatitis and reflects Lilly's and Incyte's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that OLUMIANT will receive additional regulatory approvals, or that it will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

    1 Olumiant Prescribing Information, 2020.

    2 Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.

    3 Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives on the management of atopic dermatitis. The Journal of Allergy and Clinical Immunology. 2006;118: 226-32.

    4 Thijs JL, Strickland I, Bruijnzeel-Koomen C, et. al. Moving toward endotypes in atopic dermatitis: identification of patient clusters based on serum biomarker analysis. The Journal of Allergy and Clinical Immunology. 2017.

    5 Langan SM, Thomas KS, Williams HC. What is meant by "flare" in atopic dermatitis? A systematic review and proposal. Arch Dermatol. 2006;142:1190-1196.

    6 Nutten S. Atopic dermatitis: global epidemiology and risk factors. Annals of Nutrition and Metabolism. 2015;66(suppl 1): 8-16.

    7 Yosipovitch G, Papoiu AD. What causes itch in atopic dermatitis? Current Allergy and Asthma Reports. 2008;8:306-311.

    8 Weidinger, S, Novak, N. Atopic dermatitis. The Lancet Volume 387. 2016;10023:1109-1122.

    Refer to: 

    Kristen Porter Basu; ; 317-447-2199 (media)

    Kevin Hern; ; 317-277-1838 (investors)

    Catalina Loveman; ; +1-302-498-6171 (Incyte media)

    Michael Booth, DPhil; ; +1-302-498-5914 (Incyte investors)

    Eli Lilly and Company logo. (PRNewsFoto, Eli Lilly and Company) (PRNewsfoto/Eli Lilly and Company)

    Incyte logo. (PRNewsFoto/Eli Lilly and Company) (PRNewsfoto/Eli Lilly and Company)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/chmp-recommends-approval-of-lillys-baricitinib-for-the-treatment-of-adults-with-moderate-to-severe-atopic-dermatitis-301133876.html

    SOURCE Eli Lilly and Company

    View Full Article Hide Full Article
    • Independent central review confirmed responses include 1 complete response, 12 partial responses and 33 stable disease for an objective response rate of 14% and disease control rate of 49%
    • Responses were observed regardless of PD-L1 status, presence of liver metastases or HIV+ status
    • Presentation is available on-demand as part of the ESMO Virtual Congress 2020
    • POD1UM-303/InterAACT 2, a Phase 3 trial evaluating retifanlimab plus chemotherapy in patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal is now open and recruiting patients.

    Incyte (NASDAQ:INCY) today announced results from its Phase 2 POD1UM-202 trial evaluating retifanlimab, a PD-1 inhibitor, in previously treated patients with…

    • Independent central review confirmed responses include 1 complete response, 12 partial responses and 33 stable disease for an objective response rate of 14% and disease control rate of 49%
    • Responses were observed regardless of PD-L1 status, presence of liver metastases or HIV+ status
    • Presentation is available on-demand as part of the ESMO Virtual Congress 2020
    • POD1UM-303/InterAACT 2, a Phase 3 trial evaluating retifanlimab plus chemotherapy in patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal is now open and recruiting patients.

    Incyte (NASDAQ:INCY) today announced results from its Phase 2 POD1UM-202 trial evaluating retifanlimab, a PD-1 inhibitor, in previously treated patients with advanced squamous cell carcinoma of the anal canal (SCAC) who have progressed following standard platinum-based chemotherapy. The trial enrolled 94 patients, including those with well-controlled human immunodeficiency virus (HIV) infection (10%).

    Retifanlimab monotherapy resulted in a confirmed objective response rate (ORR) of 14% as determined by independent central review (ICR) using RECIST v1.1. Responses were observed regardless of PD-L1 status, presence of liver metastases, age or HIV+ status. Retifanlimab was generally well-tolerated with a safety profile as expected of a PD-1 inhibitor and no loss of HIV infection control.

    Key findings from POD1UM-202:

     

    N=94

    ORR* (95% CI)

    13.8% (7.6-22.5)

    Best OR*, n

    1 CR

    12 PR

    33 SD

    DCR

    48.9%

    DOR, median (95% CI), months

    9.5 (5.6-NE)

    PFS, median (95% CI), months

    2.3 (1.9-3.6)

    OS, median (95% CI), months

    10.1 (7.9-NE)

    *Confirmed responses as determined by independent central review (ICR) using RECIST v1.1.

    ORR: objective response rate; CI: confidence interval; OR: objective response; CR: complete response; PR: partial response; SD: stable disease; DCR: disease control rate; DOR: duration of response; PFS: progression-free survival; OS: overall survival; NE: not estimable.

    "The results from the POD1UM-202 trial highlight the potential of retifanlimab to provide a meaningful treatment for patients with SCAC who have progressed following standard platinum-based chemotherapy and therefore have a very poor prognosis," said Lance Leopold, M.D., Group Vice President, Immuno-Oncology Clinical Development, Incyte. "These data are especially important because this trial enrolled HIV+ patients who are at the greatest risk of developing SCAC and are typically systematically excluded from oncology clinical trials."

    These results are available on-demand as part of the European Society for Medical Oncology (ESMO) 2020 Virtual Congress mini-oral sessions beginning at 9:00 am CEST on September 18th, 2020; Presentation #LBA42.

    "SCAC is a rare cancer with increasing incidence, including in patients who are HIV+, and represents a strong unmet medical need," said Sheela Rao, M.D., Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust. "Data from the POD1UM-202 trial are encouraging and support further investigation of the potential of retifanlimab to become a much needed treatment option for patients with SCAC."

    SCAC is associated with human papillomavirus (HPV) and HIV infections and accounts for almost 3% of digestive system cancers.1 Patients with metastatic SCAC have a poor 5-year survival and there are no standard treatments for patients who have progressed after first-line chemotherapy treatment.2

    POD1UM-303/InterAACT 2 (NCT04472429), a Phase 3 trial of retifanlimab in combination with carboplatin and paclitaxel in patients with inoperable locally recurrent or metastatic SCAC is now open and recruiting patients.

    About POD1UM

    The POD1UM (PD1 Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-202, POD1UM-303 and several other Phase 1, 2 and 3 studies for patients with solid tumors including squamous cell carcinoma of the anal canal (SCAC), microsatellite instability-high endometrial cancer, Merkel cell carcinoma and non-small cell lung cancer, among others.

    About POD1UM-202

    POD1UM-202 (NCT03597295) is an open-label, single-arm, multicenter, Phase 2 study evaluating retifanlimab in patients with squamous cell carcinoma of the anal canal (SCAC) who have progressed following platinum-based chemotherapy. Retifanlimab 500 mg is administered intravenously every 4 weeks.

    The primary endpoint is objective response rate (ORR) as determined by independent central review using RECIST v1.1. Secondary endpoints include additional measures of clinical benefit ‒ duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS); safety and pharmacokinetics.

    For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03597295.

    About POD1UM-303/InterAACT 2

    POD1UM-303/InterAACT 2 (NCT004472429) is a Phase 3, randomized, multicenter, double-blind study evaluating retifanlimab or placebo plus carboplatin and paclitaxel in patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).

    Adult patients, including those with well-controlled HIV infection, who have not been previously treated with systemic chemotherapy will be randomized to receive retifanlimab or placebo with standard therapy of carboplatin and paclitaxel.

    The primary endpoint is progression-free survival (PFS) as determined by blinded independent central review using RECIST v1.1. Key secondary endpoint is overall survival (OS). Other secondary endpoints include: objective response rate (ORR), duration of response (DOR), disease control rate (DCR), safety and pharmacokinetics.

    For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT04472429.

    About Retifanlimab

    Retifanlimab (formerly INCMGA0012), an investigational anti-PD1 antibody, is currently under evaluation in registration-directed trials as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell carcinoma of the anal canal (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer and SCAC.

    Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of anal cancer.

    In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and commercialization of retifanlimab in Greater China.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Forward-Looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements about the potential of retifanlimab to provide a meaningful treatment for patients with SCAC, the retifanlimab development program, and the safety and efficacy of retifanlimab in patients with squamous cell carcinoma of the anal canal, contain predictions, estimates and other forward-looking statements.

    These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended June 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

    References

    1. Ghosn M, et.al. Anal cancer treatment: current status and future perspectives. World J Gastroenterol 2015;21:2294-2302.
    2. Eng C, et al. The role of systemic chemotherapy and multidisciplinary management in improving the overall survival of patients with metastatic squamous cell carcinoma of the anal canal. Oncotarget 2014;5:11133-11142.

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  2. Analyst and investor conference call and webcast scheduled for Tuesday, September 29, 2020 at 9:00 a.m. EDT / 3:00 p.m. CEST

    PLANEGG/MUNICH and WILMINGTON, DE / ACCESSWIRE / September 17, 2020 / MorphoSys AG ((FSE: MOR, Prime Standard Segment, MDAX &amp, TecDAX, NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced that the companies intend to host a conference call and webcast to discuss global development, unmet need and commercial opportunities for tafasitamab.

    Dr. Gilles Salles will join MorphoSys and Incyte leadership as an expert speaker. Dr. Salles was the principal investigator and first author of the ICML 2019 and EHA 2020 data presentations, as well as first author of the 2020 Lancet Oncology publication of the L-MIND trial investigating…

    Analyst and investor conference call and webcast scheduled for Tuesday, September 29, 2020 at 9:00 a.m. EDT / 3:00 p.m. CEST

    PLANEGG/MUNICH and WILMINGTON, DE / ACCESSWIRE / September 17, 2020 / MorphoSys AG ((FSE: MOR, Prime Standard Segment, MDAX &, TecDAX, NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced that the companies intend to host a conference call and webcast to discuss global development, unmet need and commercial opportunities for tafasitamab.

    Dr. Gilles Salles will join MorphoSys and Incyte leadership as an expert speaker. Dr. Salles was the principal investigator and first author of the ICML 2019 and EHA 2020 data presentations, as well as first author of the 2020 Lancet Oncology publication of the L-MIND trial investigating tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.

    The conference call and webcast will be held on Tuesday, September 29, 2020 from 9:00 - 11:00 a.m. EDT / 3:00 - 5:00 p.m. CEST. The live webcast and replay will be available via www.morphosys.com and investor.incyte.com.

    To access the conference call, U.S. domestic callers please dial 877-423-0830. Callers outside of the U.S. please dial +49 69201744220 or +44 2030092470. When prompted, provide the conference pin number, 83557299#.

    About Tafasitamab

    Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

    Monjuvi(R)(tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi(R) is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

    A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

    Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

    Monjuvi(R) is a registered trademark of MorphoSys AG.
    XmAb(R) is a registered trademark of Xencor, Inc.

    Important Safety Information
    What are the possible side effects of MONJUVI?

    MONJUVI may cause serious side effects, including:

    • Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.
    • Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4 F (38 C) or above, or any bruising or bleeding.
    • Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4 F (38 C) or above, or develop any signs and symptoms of an infection.

    The most common side effects of MONJUVI include:

    • Feeling tired or weak
    • Diarrhea
    • Cough
    • Fever
    • Swelling of lower legs or hands
    • Respiratory tract infection
    • Decreased appetite

    These are not all the possible side effects of MONJUVI.
    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

    • Have an active infection or have had one recently.
    • Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
    • You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
    • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
    • Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.

    You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

    Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

    About MorphoSys

    MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, 27 of which are currently in clinical development. In 2017, Tremfya(R), marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration approved the company's proprietary product Monjuvi(R) (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees. More information at www.morphosys.com.

    Tremfya(R) is a registered trademark of Janssen Biotech.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    For more information, please contact:

    MorphoSys
    Media Contacts:
    Jeanette Bressi
    Director, US Communications
    Tel: +1 617-404-7816
    Investor Contacts:
    Dr. Anja Pomrehn
    Senior Vice President
    Tel: +49 (0)89 / 899 27 26972

    Sophie Petersen
    Senior Specialist
    Tel: +49 (0)89 899 27 26033

    Dr. Julia Neugebauer
    Director
    Tel: +49 (0)89 / 899 27 179

    Incyte
    Media Contact:
    Catalina Loveman
    Executive Director, Public Affairs
    Tel: +1 302 498 6171
    Investor Contact:
    Dr. Michael Booth
    Division VP, IR & Global Responsibility
    Tel: +1 302 498 5914

    SOURCE: MorphoSys AG



    View source version on accesswire.com:
    https://www.accesswire.com/606634/MorphoSys-and-Incyte-to-Host-Investor-Event-to-Discuss-the-Unmet-Need-and-Global-Opportunities-for-Tafasitamab-in-Non-Hodgkin-Lymphomas

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  3. - Analyst and investor conference call and webcast scheduled for Tuesday, September 29, 2020 at 9:00 a.m. EDT / 3:00 p.m. CEST

    Incyte (NASDAQ:INCY) and MorphoSys AG ((FSE: MOR, Prime Standard Segment, MDAX &amp, TecDAX, NASDAQ:MOR) today announced that the companies intend to host a conference call and webcast to discuss global development, unmet need and commercial opportunities for tafasitamab.

    Dr. Gilles Salles will join Incyte and MorphoSys leadership as an expert speaker. Dr. Salles was the principal investigator and first author of the ICML 2019 and EHA 2020 data presentations, as well as first author of the 2020 Lancet Oncology publication of the L-MIND trial investigating tafasitamab in combination with lenalidomide for the treatment…

    - Analyst and investor conference call and webcast scheduled for Tuesday, September 29, 2020 at 9:00 a.m. EDT / 3:00 p.m. CEST

    Incyte (NASDAQ:INCY) and MorphoSys AG ((FSE: MOR, Prime Standard Segment, MDAX &, TecDAX, NASDAQ:MOR) today announced that the companies intend to host a conference call and webcast to discuss global development, unmet need and commercial opportunities for tafasitamab.

    Dr. Gilles Salles will join Incyte and MorphoSys leadership as an expert speaker. Dr. Salles was the principal investigator and first author of the ICML 2019 and EHA 2020 data presentations, as well as first author of the 2020 Lancet Oncology publication of the L-MIND trial investigating tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.

    The conference call and webcast will be held on Tuesday, September 29, 2020 from 9:00 – 11:00 a.m. EDT / 3:00 – 5:00 p.m. CEST. The live webcast and replay will be available via www.morphosys.com and investor.incyte.com.

    To access the conference call, U.S. domestic callers please dial 877-423-0830. Callers outside of the U.S. please dial +49 69201744220 or +44 2030092470. When prompted, provide the conference pin number, 83557299#.

    About Tafasitamab

    Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

    Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

    A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

    Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

    Monjuvi® is a registered trademark of MorphoSys AG.

    XmAb® is a registered trademark of Xencor, Inc.

    Important Safety Information

    What are the possible side effects of MONJUVI?

    MONJUVI may cause serious side effects, including:

    • Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.
    • Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
    • Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs and symptoms of an infection.

    The most common side effects of MONJUVI include:

    • Feeling tired or weak
    • Diarrhea
    • Cough
    • Fever
    • Swelling of lower legs or hands
    • Respiratory tract infection
    • Decreased appetite

    These are not all the possible side effects of MONJUVI.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

    • Have an active infection or have had one recently.
    • Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
      • You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
      • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
    • Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.

    You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

    Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    About MorphoSys

    MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, 27 of which are currently in clinical development. In 2017, Tremfya®, marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020 the U.S. Food and Drug Administration approved the company's proprietary product Monjuvi® (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees. More information at www.morphosys.com.

    Tremfya® is a registered trademark of Janssen Biotech.

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  4. INDIANAPOLIS, Sept. 14, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today initial data emerging from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). ACTT-2 included more than 1,000 patients and began on May 8 to assess the efficacy and safety of a 4-mg dose of baricitinib plus remdesivir versus remdesivir in hospitalized patients with COVID-19. Baricitinib in combination with remdesivir met the primary endpoint of reduction of time to recovery in comparison with remdesivir.

    Study investigators noted an approximately one-day reduction in median recovery time for the overall…

    INDIANAPOLIS, Sept. 14, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today initial data emerging from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). ACTT-2 included more than 1,000 patients and began on May 8 to assess the efficacy and safety of a 4-mg dose of baricitinib plus remdesivir versus remdesivir in hospitalized patients with COVID-19. Baricitinib in combination with remdesivir met the primary endpoint of reduction of time to recovery in comparison with remdesivir.

    Study investigators noted an approximately one-day reduction in median recovery time for the overall patient population treated with baricitinib in combination with remdesivir versus those treated with remdesivir. This finding was statistically significant. Recovery was defined as the participant being well enough for hospital discharge, meaning the participant either no longer required supplemental oxygen or ongoing medical care in the hospital, or was no longer hospitalized at Day 29. The study also met a key secondary endpoint comparing patient outcomes at Day 15 using an ordinal 8-point scale ranging from fully recovered to death.

    An independent data and safety monitoring board overseeing the double-blind, randomized controlled trial met regularly throughout the trial to review safety data. Additional analyses are ongoing to understand other clinical outcome data, including mortality and safety data. NIAID is expected to publish full details of the study in a peer-reviewed journal.

    "We are pleased with these data from the ACTT-2 study," said Patrik Jonsson, Lilly senior vice president and president of Lilly Bio-Medicines. "There is an urgent need to identify COVID-19 treatments, and we will continue to work with NIAID to understand these data and next steps on baricitinib's role moving forward. We appreciate NIAID selecting baricitinib for inclusion in this important study and the participants, investigators and collaborators for the vital roles they played." 

    "These findings from ACTT-2 are another step as we improve the care of these patients," said Andre Kalil, M.D., professor at the University of Nebraska Medical Center and a principal investigator of the ACTT studies. "These data may help us to better understand baricitinib's potential role in the treatment of COVID-19."

    Based on the ACTT-2 data, Lilly plans to discuss the potential for emergency use authorization (EUA) with the U.S. Food and Drug Administration (FDA) and to explore similar measures with other regulatory agencies for baricitinib as a treatment of hospitalized patients with COVID-19. If authorized for use, Lilly will propose that baricitinib be available through commercial channels and will work with hospitals and governments to ensure patient access. Lilly will continue to create adequate supply for rheumatoid arthritis (RA) patients and ensure baricitinib remains available in countries where it is approved. In the U.S., baricitinib is approved for RA patients at a 2-mg daily dose; an EUA would potentially authorize a 4-mg dose for COVID-19.

    Lilly will review the ACTT-2 data with NIAID and assess any impact on COV-BARRIER, the Phase 3 randomized, double-blind, placebo-controlled study it initiated in June to evaluate the efficacy and safety of baricitinib versus background therapy in hospitalized adults with COVID-19 in the U.S., Europe, Asia and Latin America. 

    "As a company, we've moved quickly to develop and evaluate medicines for patients for the prevention and treatment of COVID-19," said Daniel Skovronsky, M.D., Ph.D., Lilly senior vice president and chief scientific officer. "These data allow us to better understand baricitinib's role in potentially improving outcomes for hospitalized COVID-19 patients, and we look forward to continuing this research alongside our other initiatives to combat COVID-19."

    Baricitinib, a JAK1/JAK2 inhibitor licensed to Lilly from Incyte and marketed as OLUMIANT®, is approved in more than 70 countries as a treatment for adults with moderately to severely active RA. Studying baricitinib in controlled trials is important in order to better characterize its potential benefits and understand the safety of its use as a COVID-19 treatment. The U.S. prescribing information for the approved use of baricitinib for RA includes boxed warnings regarding the use of baricitinib, including warnings about risk for developing blood clots and serious infections.

    Lilly is also currently supporting ongoing multisite and single-site investigator-initiated trials in Europe and North America for hospitalized patients with COVID-19 infections.

    About Lilly's COVID-19 Efforts

    Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are now being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with two partner companies to discover novel antibody treatments for COVID-19. Lilly intends to test both single antibody therapy as well as combinations of antibodies (sometimes known as antibody cocktails) as potential therapeutics for COVID-19. Click here for media resources related to Lilly's COVID-19 efforts.

    Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients

    OLUMIANT® (baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

    IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) TABLETS 

    WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS

    SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:

    • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.
    • Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
    • Bacterial, viral, and other infections due to opportunistic pathogens.

    Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.

    Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

    MALIGNANCIES: Lymphoma and other malignancies have been observed in patients treated with Olumiant.

    THROMBOSIS: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.

    WARNINGS AND PRECAUTIONS

    SERIOUS INFECTIONS: The most common serious infections reported with Olumiant included pneumonia, herpes zoster and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than local disease and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients:

    • with chronic or recurrent infection
    • who have been exposed to TB
    • with a history of a serious or an opportunistic infection
    • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
    • with underlying conditions that may predispose them to infection.

    Closely monitor patients for infections during and after Olumiant treatment. Interrupt Olumiant if a patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume Olumiant until the infection is controlled.

    Tuberculosis Before initiating Olumiant evaluate and test patients for latent or active infection and treat patients with latent TB with standard antimycobacterial therapy. Olumiant should not be given to patients with active TB. Consider anti-TB therapy prior to initiating Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Monitor patients for TB during Olumiant treatment.

    Viral Reactivation – Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves.

    The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.

    MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS: Malignancies were observed in Olumiant clinical studies. Consider the risks and benefits of Olumiant prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing Olumiant in patients who develop a malignancy. NMSCs were reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

    THROMBOSIS:  Thrombosis, including DVT and PE, has been observed at an increased incidence in Olumiant-treated patients compared to placebo. In addition, arterial thrombosis events in the extremities have been reported in clinical studies with Olumiant. Many of these adverse events were serious and some resulted in death. There was no clear relationship between platelet count elevations and thrombotic events. Use Olumiant with caution in patients who may be at increased risk of thrombosis. If clinical features of DVT/PE or arterial thrombosis occur, evaluate patients promptly and treat appropriately.

    GASTROINTESTINAL PERFORATIONS: Gastrointestinal perforations have been reported in Olumiant clinical studies, although the role of JAK inhibition in these events is not known. Use Olumiant with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.

    LABORATORY ABNORMALITIES:

    Neutropenia – Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3) compared to placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

    Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

    Anemia – Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

    Liver Enzyme Elevations – Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of ALT ≥5x upper limit of normal (ULN) and increases of AST ≥10x ULN were observed in patients in Olumiant clinical trials.

    Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.

    Lipid Elevations – Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation. Manage patients according to clinical guidelines for the management of hyperlipidemia.

    VACCINATIONSAvoid use of live vaccines with Olumiant. Update immunizations in agreement with current immunization guidelines prior to initiating Olumiant therapy.

    HYPERSENSITIVITY: Reactions such as angioedema, urticaria, and rash that may reflect drug sensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.

    ADVERSE REACTIONS

    Most common adverse reactions include: upper respiratory tract infections (16.3%, 11.7%), nausea (2.7%, 1.6%), herpes simplex (0.8%, 0.7%) and herpes zoster (1.0%, 0.4%) for Olumiant 2 mg and placebo, respectively.

    USE IN SPECIFIC POPULATIONS

    PREGNANCY AND LACTATION: No information is available to support the use of Olumiant in pregnancy or lactation. Advise women not to breastfeed during treatment with Olumiant.

    HEPATIC AND RENAL IMPAIRMENT: Olumiant is not recommended in patients with severe hepatic impairment or in patients with severe renal impairment.

    Please click to access full Prescribing Information, including Boxed Warning about Serious Infections, Malignancies, and Thrombosis, and Medication Guide.

    BA HCP ISI 09JUL2020

    About OLUMIANT®

    OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.i There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.ii OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.i 

    In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

    About Eli Lilly and Company 

    Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY

    About Incyte 

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a potential treatment for patients with COVID-19 and as a treatment for patients with rheumatoid arthritis, and about the supply of OLUMIANT, and reflects Lilly's and Incyte's current beliefs. This press release also contains a forward-looking statement about Lilly's potential antibody treatments for COVID-19. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that OLUMIANT will receive additional regulatory approvals or continue to be commercially successful, that we can provide an adequate supply of OLUMIANT in all circumstances, or that potential antibody treatments will be safe and effective. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

    i Olumiant Prescribing Information, 2020.

    ii Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.

    Refer to:            

    Kristen Porter Basu; ; 317-447-2199 (media)



    Kevin Hern; ; 317-277-1838 (investors)



    Catalina Loveman; ; 302-498-6171 (Incyte media)



    Michael Booth, DPhil; ; 302-498-5914 (Incyte investors)  

     

    Eli Lilly and Company logo. (PRNewsfoto/Eli Lilly and Company)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/baricitinib-in-combination-with-remdesivir-reduces-time-to-recovery-in-hospitalized-patients-with-covid-19-in-niaid-sponsored-actt-2-trial-301129865.html

    SOURCE Eli Lilly and Company

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