SGEN Seagen Inc.

185.78
-5.02  -3%
Previous Close 190.8
Open 190.42
52 Week Low 90.57
52 Week High 213.94
Market Cap $33,253,992,064
Shares 178,996,620
Float 60,399,501
Enterprise Value $32,499,183,096
Volume 608,540
Av. Daily Volume 948,085
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Drug Pipeline

Drug Stage Notes
Tisotumab Vedotin (innovaTV 301)
Cervical Cancer
Phase 3
Phase 3
Phase 3 trial initiation announced January 5, 2021.
Enfortumab Vedotin - EV-201
Urothelial Cancer
Phase 2
Phase 2
Phase 2 data released October 12, 2020 - ORR 52%.
Enfortumab vedotin - EV-202
Solid tumors
Phase 2
Phase 2
Phase 2 trial initiated January 2020.
Enfortumab vedotin - EV-301
Urothelial cancer
Phase 3
Phase 3
Phase 3 trial met primary endpoint - September 18, 2020.
Enfortumab vedotin and Keytruda - EV-301
Urothelial cancer
Phase 3
Phase 3
Phase 3 enrolment completed in January 2020.
GSK’916 - belantamab mafodotin (BCMA)
Multiple myeloma
Approved
Approved
FDA approval granted August 5, 2020.
SEA-TGT
Solid tumors
Phase 1
Phase 1
Phase 1 trial initiation announced June 18, 2020.
SGN-B6A
Solid Tumors
Phase 1
Phase 1
Phase 1 trial initiation announced June 18, 2020.
ADCETRIS
Hodgkin lymphoma and Anaplastic large cell lymphoma
Approved
Approved
Approval announced August 19, 2011.
ADCETRIS - AETHERA
Post-transplant Hodgkin lymphoma (HL) cancer
Approved
Approved
Approved August 17, 2015 under priority review.
ADCETRIS in combination with chemotherapy - ECHELON-2
Frontline CD30-positive mature T-cell lymphomas - cancer
Approved
Approved
FDA Approval announced November 16, 2018.
ADCETRIS in combination with chemotherapy ECHELON-1
Frontline Hodgkin lymphoma
Approved
Approved
sBLA approval announced March 20, 2018. PDUFA date under priority review was May 1, 2018.
Tucatinib in combination with trastuzumab and capecitabine
HER2+ Metastatic Breast Cancer (MBC)
Approved
Approved
FDA Approval announced April 17, 2020.
Enfortumab vedotin and Keytruda EV-103
Urothelial cancer
Phase 1/2
Phase 1/2
Phase 1/2 data noted Overall response rate 73%; Complete response rate 16% (partial response rate 58%).
Enfortumab vedotin
Urothelial cancer
Approved
Approved
FDA Approval announced December 18, 2019.
Tucatinib - MOUNTAINEER
HER2 amplified metastatic colorectal cancer
Phase 2
Phase 2
Phase 2 data at ESMO noted 52% ORR, median PFS 8.1 months, OS of 18.7 months.
Tucatinib + ado-trastuzumab emtansine (T-DM1, Kadcyla), - HER2CLIMB-02
HER2+ Metastatic Breast Cancer (MBC)
Phase 3
Phase 3
Phase 3 trial initiation announced October 10, 2019.
Polatuzumab vedotin and bendamustine plus Rituxan (rituximab)
Diffuse large B-cell lymphoma (DLBCL)
Approved
Approved
FDA approval announced June 10, 2019.
ADCETRIS
Cancer - ALCANZA trial for relapsed CD30-positive cutaneous T-cell lymphoma
Approved
Approved
Approval announced November 9, 2017.
Vadastuximab Talirine (CASCADE)
Acute myeloid leukemia (AML) - cancer
Phase 3
Phase 3
Phase 3 trial discontinued due to higher rate of deaths - June 19, 2017.

Latest News

  1. Seagen Inc. (NASDAQ:SGEN) today announced that it will report its fourth quarter and full year 2020 financial results on Thursday, February 11, 2021 after the close of U.S. financial markets. Following the announcement, Company management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows:

    Thursday, February 11, 2021

    1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

    • Telephone 844-763-8274 (domestic) or +1 412-717-9224 (international); conference ID 10150708
    • Webcast with slides available at www.seagen.com in the Investors section. A webcast replay will be archived on the Company's website.

    About Seagen

    Seagen is a global biotechnology…

    Seagen Inc. (NASDAQ:SGEN) today announced that it will report its fourth quarter and full year 2020 financial results on Thursday, February 11, 2021 after the close of U.S. financial markets. Following the announcement, Company management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows:

    Thursday, February 11, 2021

    1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

    • Telephone 844-763-8274 (domestic) or +1 412-717-9224 (international); conference ID 10150708
    • Webcast with slides available at www.seagen.com in the Investors section. A webcast replay will be archived on the Company's website.

    About Seagen

    Seagen is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people's lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland and the European Union. For more information on the company's marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal on Twitter.

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  2. Seagen Inc. (NASDAQ:SGEN) today announced that management will present at the 39th Annual J.P. Morgan Virtual Healthcare Conference on Monday, January 11, 2021 at 2:00 p.m. Eastern Time. The presentation will be webcast live and available for replay from Seagen's website at www.seagen.com in the Investors section.

    About Seagen

    Seagen is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people's lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland and the European Union. For more information on the company's marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal

    Seagen Inc. (NASDAQ:SGEN) today announced that management will present at the 39th Annual J.P. Morgan Virtual Healthcare Conference on Monday, January 11, 2021 at 2:00 p.m. Eastern Time. The presentation will be webcast live and available for replay from Seagen's website at www.seagen.com in the Investors section.

    About Seagen

    Seagen is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people's lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland and the European Union. For more information on the company's marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal on Twitter.

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  3. Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced that Natasha A. Hernday has joined Alpine's Board of Directors. Ms. Hernday brings more than 20 years of experience in corporate development and corporate strategy.

    "I'm delighted to welcome Natasha to Alpine Immune Sciences' Board at this important moment in our company's history, as we build on our strategic partnership with AbbVie and leverage Alpine's financial strength to further advance our development pipeline," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "I look forward to benefiting from Natasha's…

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced that Natasha A. Hernday has joined Alpine's Board of Directors. Ms. Hernday brings more than 20 years of experience in corporate development and corporate strategy.

    "I'm delighted to welcome Natasha to Alpine Immune Sciences' Board at this important moment in our company's history, as we build on our strategic partnership with AbbVie and leverage Alpine's financial strength to further advance our development pipeline," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "I look forward to benefiting from Natasha's extensive experience and acumen as we oversee the next stages of Alpine's growth to the benefit of Alpiners, shareholders and patients alike."

    Ms. Hernday currently serves as Executive Vice President, Corporate Development and as a member of the Executive Committee for the publicly traded biotechnology company Seagen, Inc. (NASDAQ:SGEN). Since joining Seagen in 2011, Ms. Hernday has built and led the business development team responsible for licensing deals, acquisitions and strategic alliances. From 1994 through 2010, after starting her career in molecular and mammalian cell biology, Ms. Hernday served in various roles of increasing responsibility at Amgen Inc., including as Director, Mergers & Acquisitions and as Director, Out-Partnering. She also serves on the board of directors of Xoma Corp. (NASDAQ:XOMA) and PDL BioPharma, Inc. (NASDAQ:PDLI), and on the Knight Campus External Advisory Board for the University of Oregon.

    Ms. Hernday received her BA in microbiology from the University of California at Santa Barbara and MBA from Pepperdine University.

    Concurrent with Ms. Hernday joining Alpine's Board of Directors, the company also announced that Paul Sekhri will be stepping down as a director of the company. Mr. Sekhri has served on Alpine's Board of Directors since February 2016.

    Mitchell H. Gold commented, "On behalf of the Board and Alpine's executive team, I would like to thank Paul for the service he has provided to the company and wish him well in any and all future endeavors."

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics. With world-class research and development capabilities, a highly productive scientific platform, and a proven management team, Alpine is creating multifunctional immunotherapies via unique protein engineering technologies designed to improve patients' lives. Alpine has entered into strategic collaborations with leading global biopharmaceutical companies and has a diverse pipeline of clinical and preclinical candidates in development. For more information, visit www.alpineimmunesciences.com. Follow @AlpineImmuneSci on Twitter and LinkedIn.

    Forward-Looking Statements

    This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies, the future development plans and commercial potential of our product candidates, the progress and potential of our other ongoing development programs, and our ability to successfully develop and achieve milestones in our development programs. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as "may," "will," "should," "would," "expect," "plan," "intend," and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations; our discovery-stage and preclinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Secreted Immunomodulatory Proteins", "SIP", "Transmembrane Immunomodulatory Protein," "TIP," "Variant Ig Domain," "vIgD" and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

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  4. - Recommendation for Approval in the European Union Based on Results of Pivotal HER2CLIMB Trial -

    Seagen Inc. (NASDAQ:SGEN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending the approval of TUKYSA® (tucatinib) in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens. TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth.1,2

    The CHMP positive opinion will now be considered by the European Commission (EC), which has the…

    - Recommendation for Approval in the European Union Based on Results of Pivotal HER2CLIMB Trial -

    Seagen Inc. (NASDAQ:SGEN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending the approval of TUKYSA® (tucatinib) in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens. TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth.1,2

    The CHMP positive opinion will now be considered by the European Commission (EC), which has the authority to approve medicines in the European Union (EU). TUKYSA is approved in the United States, Canada, Switzerland, Singapore and Australia.

    "We are pleased the CHMP has recognized TUKYSA as a meaningful clinical advance for people with advanced HER2-positive metastatic breast cancer, including those with cancer that has spread to the brain," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "This opinion brings us one step closer to making TUKYSA available to patients in the EU and aligns with our commitment to bring innovative therapies to patients around the world."

    The positive CHMP opinion is based on results of the pivotal trial HER2CLIMB and were published in The New England Journal of Medicine in December 2019.

    About HER2CLIMB

    HER2CLIMB is a randomized, double-blind, placebo-controlled, active comparator, global trial that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1). The results for the primary endpoint showed patients who received TUKYSA in combination with trastuzumab and capecitabine had a 46 percent reduction in the risk of cancer progression or death (PFS) compared to patients who received trastuzumab and capecitabine alone (hazard ratio (HR)=0.54 [95% Confidence Interval (CI): 0.42, 0.71]; p<0.00001). A secondary endpoint showed that the addition of TUKYSA reduced the risk of death (OS) by 34 percent compared to trastuzumab and capecitabine alone (HR=0.66 [95% CI: 0.50, 0.87]; p=0.0048). Based on the results, TUKYSA was approved in the U.S. in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

    About HER2-Positive Breast Cancer

    Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. In 2018, more than two million new cases of breast cancer were diagnosed worldwide, including 522,513 in Europe.3 Between 15 and 20 percent of breast cancer cases are HER2-positive.4 Historically, HER2-positive breast cancer tends to be more aggressive and more likely to recur than HER2-negative breast cancer.5,4,6 Up to 50 percent of metastatic HER2-positive breast cancer patients develop brain metastases over time.7,8,9

    About TUKYSA (tucatinib)

    TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.1

    U.S. Important Safety Information

    Warnings and Precautions

    • Diarrhea – TUKYSA can cause severe diarrhea including dehydration, hypotension, acute kidney injury, and death. In HER2CLIMB, 81% of patients who received TUKYSA experienced diarrhea, including 12% with Grade 3 diarrhea and 0.5% with Grade 4 diarrhea. Both patients who developed Grade 4 diarrhea subsequently died, with diarrhea as a contributor to death. The median time to onset of the first episode of diarrhea was 12 days and the median time to resolution was 8 days. Diarrhea led to dose reductions of TUKYSA in 6% of patients and discontinuation of TUKYSA in 1% of patients. Prophylactic use of antidiarrheal treatment was not required on HER2CLIMB.



      If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
    • Hepatotoxicity – TUKYSA can cause severe hepatotoxicity. In HER2CLIMB, 8% of patients who received TUKYSA had an ALT increase >5 × ULN, 6% had an AST increase >5 × ULN, and 1.5% had a bilirubin increase >3 × ULN (Grade ≥3). Hepatotoxicity led to dose reduction of TUKYSA in 8% of patients and discontinuation of TUKYSA in 1.5% of patients.



      Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatotoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
    • Embryo-Fetal Toxicity – TUKYSA can cause fetal harm. Advise pregnant women and females of reproductive potential risk to a fetus. Advise females of reproductive potential, and male patients with female partners of reproductive potential, to use effective contraception during TUKYSA treatment and for at least 1 week after the last dose.

    Adverse Reactions

    Serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in ≥2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.

    Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in ≥1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in ≥2% of patients were hepatotoxicity (8%) and diarrhea (6%).

    The most common adverse reactions in patients who received TUKYSA (≥20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

    Lab Abnormalities

    In HER2CLIMB, Grade ≥3 laboratory abnormalities reported in ≥5% of patients who received TUKYSA were: decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

    Drug Interactions

    • Strong CYP3A or Moderate CYP2C8 Inducers: Concomitant use may decrease TUKYSA activity. Avoid concomitant use of TUKYSA.
    • Strong or Moderate CYP2C8 Inhibitors: Concomitant use of TUKYSA with a strong CYP2C8 inhibitor may increase the risk of TUKYSA toxicity; avoid concomitant use. Increase monitoring for TUKYSA toxicity with moderate CYP2C8 inhibitors.
    • CYP3A Substrates: Concomitant use may increase the toxicity associated with a CYP3A substrate. Avoid concomitant use of TUKYSA where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP3A substrate dosage.
    • P-gp Substrates: Concomitant use may increase the toxicity associated with a P-gp substrate. Consider reducing the dosage of P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicity.

    Use in Specific Populations

    • Lactation: Advise women not to breastfeed while taking TUKYSA and for at least 1 week after the last dose.
    • Renal Impairment: Use of TUKYSA in combination with capecitabine and trastuzumab is not recommended in patients with severe renal impairment (CLcr < 30 mL/min), because capecitabine is contraindicated in patients with severe renal impairment.
    • Hepatic Impairment: Reduce the dose of TUKYSA for patients with severe (Child-Pugh C) hepatic impairment.

    For more information, please see the full Prescribing Information for TUKYSA here.

    About Seagen

    Seagen is a global biotechnology company that discovers, develops, and commercializes transformative cancer medicines to make a meaningful difference in people's lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland, and the European Union. For more information on the company's marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal on Twitter.

    Forward-Looking Statements

    Certain statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of TUKYSA including its efficacy, safety and therapeutic uses. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the difficulty and uncertainty of pharmaceutical product development, the risk of adverse events or safety signals, the inability to show sufficient activity in clinical trials and the possibility of adverse regulatory actions. More information about the risks and uncertainties faced by Seagen is contained under the caption "Risk Factors" included in the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 filed with the Securities and Exchange Commission. Seagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

    _________________________

    1 https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tukysa_en.pdf

    2 Anita Kulukian, Patrice Lee, Janelle Taylor, et al. Preclinical Activity of HER2-Selective Tyrosine Kinase Inhibitor Tucatinib as a Single Agent or in Combination with Trastuzumab or Docetaxel in Solid Tumor ModelsMol Cancer Ther 2020;19:976-987.

    3 Breast. Globocan 2018. World Health Organization. 2019. https://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf

    4 Slamon D, Clark G, Wong S, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu onco­gene. Science. 1987; 235(4785): 177-82.

    5 Loibli S, Gianni L. HER2-positive breast cancer. Lancet. 2017; 389(10087): 2415-29.

    6 Breast Cancer HER2 Status. American Cancer Society website. https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-her2-status.html. Accessed March 9, 2020.

    7 Freedman RA, Gelman RS, Anders CK, et al. TBCRC 022: a phase II trial of neratinib and capecitabine for patients with human epidermal growth factor receptor 2-positive breast cancer and brain metastases. J Clin Oncol. 2019;37:1081-1089.

    8 Olson EM, Najita JS, Sohl J, et al. Clinical outcomes and treatment practice patterns of patients with HER2-positive metastatic breast cancer in the post-trastuzumab era. Breast. 2013;22:525-531.

    9 Bendell JC, Domchek SM, Burstein HJ, et al. Central nervous system metastases in women who receive trastuzumab-based therapy for metastatic breast carcinoma. Cancer. 2003;97:2972-2977.

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  5. - New analyses from the pivotal HER2CLIMB trial describe outcomes by hormone receptor status -

    Seagen Inc. (NASDAQ:SGEN) today announced the presentation of new data from TUKYSA (tucatinib), its HER2-positive metastatic breast cancer therapy, at the San Antonio Breast Cancer Symposium (SABCS) Virtual Symposium, taking place December 8-11, 2020. Nine abstracts – including two spotlight posters – highlight the company's commitment to addressing unmet needs in breast cancer.

    "Following this year's FDA approval of TUKYSA, we continue to broadly study if more patients may benefit from this important medicine," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "Data presented at the meeting from the HER2CLIMB trial demonstrate TUKYSA's…

    - New analyses from the pivotal HER2CLIMB trial describe outcomes by hormone receptor status -

    Seagen Inc. (NASDAQ:SGEN) today announced the presentation of new data from TUKYSA (tucatinib), its HER2-positive metastatic breast cancer therapy, at the San Antonio Breast Cancer Symposium (SABCS) Virtual Symposium, taking place December 8-11, 2020. Nine abstracts – including two spotlight posters – highlight the company's commitment to addressing unmet needs in breast cancer.

    "Following this year's FDA approval of TUKYSA, we continue to broadly study if more patients may benefit from this important medicine," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "Data presented at the meeting from the HER2CLIMB trial demonstrate TUKYSA's efficacy regardless of patients' hormone receptor status, while other clinical and preclinical findings provide new insights about TUKYSA's potential to help patients living with HER2-positive metastatic breast cancer."

    Highlights for key data presentations at the meeting include:

    Efficacy Outcomes by Hormone Receptor Status from HER2CLIMB Trial

    Outcomes for TUKYSA® (tucatinib) in combination with trastuzumab and capecitabine in patients with HER2-positive metastatic breast cancer from the pivotal HER2CLIMB trial by hormone receptor (HR) status will be featured in a spotlight poster (Abstract #PD3-08). Results will be presented by Erika P. Hamilton, M.D., Director, Breast Cancer and Gynecologic Cancer Research Program at the Sarah Cannon Research Institute.

    As previously reported, the addition of TUKYSA to trastuzumab and capecitabine resulted in clinically meaningful improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to the addition of placebo. The new exploratory analyses presented at SABCS demonstrated that the PFS, OS and ORR improvements with TUKYSA were observed consistently across hormone receptor status subgroups, including in patients with brain metastases.

    SABCS 2020 Data Presentations for Seagen Medicines and Pipeline Agents:

    Below are presentation details related to TUKYSA and the investigational agent ladiratuzumab vedotin at SABCS. Published abstracts can be found here. Poster presentations will be available on December 9, 2020.

    Abstract Title

    Abstract No.

    Presentation

    Type / Date

    Presenter

    Tucatinib versus placebo in combination with trastuzumab and capecitabine for patients with locally advanced unresectable or HER2-positive metastatic breast cancer (HER2CLIMB): outcomes by hormone receptor status

    #PD3-08

    Spotlight Poster Discussion 3 – Wednesday, Dec. 9 from 6:45 - 7:45 p.m. CT

    E. Hamilton

    Impact of tucatinib on health-related quality of life in patients with HER2+ metastatic breast cancer with stable and active brain metastases

    #PD13-04

    Spotlight Poster Discussion 13 – Friday, Dec. 11 from 1 – 2:15 p.m. CT

    A. Wardley

    Tucatinib favourably modulates the immune microenvironment and synergises with anti-PD1 therapy in a trastuzumab resistant HER2+ murine model

    #PS10-04

    Poster Session 10 / Wednesday, Dec. 9 at 8 a.m. CT

    R. Li

    Tucatinib potentiates the activity of the antibody-drug conjugate T-DM1 in preclinical models of HER2-positive breast cancer

    #PS10-08

    Poster Session 10 / Wednesday, Dec. 9 at 8 a.m. CT

    A. Kulukian

    Real world treatment patterns and healthcare resource utilization among HER2+ metastatic breast cancer patients with and without brain metastases: a retrospective cohort study

    #PS14-15

    Poster Session 14 / Wednesday, Dec. 9 at 8 a.m. CT

    C. Ike

    Interim safety and efficacy analysis of phase IB/II clinical trial of tucatinib, palbociclib and letrozole in patients with hormone receptor and HER2-positive metastatic breast cancer

    #PS10-03

    Poster Session 10 / Wednesday, Dec. 9 at 8 a.m. CT

    E. Shagisultanova

    Trials-in-Progress

    HER2CLIMB-02: A randomized, double-blind, phase 3 study of tucatinib or placebo with T-DM1 for unresectable locally-advanced or metastatic HER2+ breast cancer

    #OT-28-01

    Ongoing Trials Posters / Wednesday, Dec. 9 at 8 a.m. CT

    S. Hurvitz

    SGNLVA-001: a phase 1 open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer

    #OT-03-03

    Ongoing Trials Posters / Wednesday, Dec. 9 at 8 a.m. CT

    H.C. Beckwith

    About TUKYSA (tucatinib)

    TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone. In the U.S., TUKYSA is approved in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases (disease that has spread to the brain), who have received one or more prior anti-HER2-based regimens in the metastatic setting. TUKYSA is approved in the U.S., Switzerland, Canada, Singapore and Australia and is under review in the European Union. As part of a strategic collaboration announced in September 2020 with Merck, known as MSD outside the United States and Canada, Merck has exclusive rights to commercialize TUKYSA in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe.

    U.S. Important Safety Information

    Warnings and Precautions

    • Diarrhea – TUKYSA can cause severe diarrhea including dehydration, hypotension, acute kidney injury, and death. In HER2CLIMB, 81% of patients who received TUKYSA experienced diarrhea, including 12% with Grade 3 diarrhea and 0.5% with Grade 4 diarrhea. Both patients who developed Grade 4 diarrhea subsequently died, with diarrhea as a contributor to death. The median time to onset of the first episode of diarrhea was 12 days and the median time to resolution was 8 days. Diarrhea led to dose reductions of TUKYSA in 6% of patients and discontinuation of TUKYSA in 1% of patients. Prophylactic use of antidiarrheal treatment was not required on HER2CLIMB.



      If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.

    • Hepatotoxicity – TUKYSA can cause severe hepatotoxicity. In HER2CLIMB, 8% of patients who received TUKYSA had an ALT increase >5 × ULN, 6% had an AST increase >5 × ULN, and 1.5% had a bilirubin increase >3 × ULN (Grade ≥3). Hepatotoxicity led to dose reduction of TUKYSA in 8% of patients and discontinuation of TUKYSA in 1.5% of patients.



      Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatotoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
    • Embryo-Fetal Toxicity – TUKYSA can cause fetal harm. Advise pregnant women and females of reproductive potential risk to a fetus. Advise females of reproductive potential, and male patients with female partners of reproductive potential, to use effective contraception during TUKYSA treatment and for at least 1 week after the last dose.

    Adverse Reactions

    Serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in ≥2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.

    Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in ≥1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in ≥2% of patients were hepatotoxicity (8%) and diarrhea (6%).

    The most common adverse reactions in patients who received TUKYSA (≥20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

    Lab Abnormalities

    In HER2CLIMB, Grade ≥3 laboratory abnormalities reported in ≥5% of patients who received TUKYSA were: decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

    Drug Interactions

    • Strong CYP3A or Moderate CYP2C8 Inducers: Concomitant use may decrease TUKYSA activity. Avoid concomitant use of TUKYSA.
    • Strong or Moderate CYP2C8 Inhibitors: Concomitant use of TUKYSA with a strong CYP2C8 inhibitor may increase the risk of TUKYSA toxicity; avoid concomitant use. Increase monitoring for TUKYSA toxicity with moderate CYP2C8 inhibitors.
    • CYP3A Substrates: Concomitant use may increase the toxicity associated with a CYP3A substrate. Avoid concomitant use of TUKYSA where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP3A substrate dosage.
    • P-gp Substrates: Concomitant use may increase the toxicity associated with a P-gp substrate. Consider reducing the dosage of P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicity.

    Use in Specific Populations

    • Lactation: Advise women not to breastfeed while taking TUKYSA and for at least 1 week after the last dose.
    • Renal Impairment: Use of TUKYSA in combination with capecitabine and trastuzumab is not recommended in patients with severe renal impairment (CLcr < 30 mL/min), because capecitabine is contraindicated in patients with severe renal impairment.
    • Hepatic Impairment: Reduce the dose of TUKYSA for patients with severe (Child-Pugh C) hepatic impairment.

    For more information, please see the full Prescribing Information for TUKYSA here.

    About Seagen

    Seagen is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people's lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland and the European Union. For more information on the company's marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal on Twitter.

    Forward Looking Statements

    Certain statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of TUKYSA including its efficacy, safety and therapeutic uses. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the difficulty and uncertainty of pharmaceutical product development, the risk of adverse events or safety signals, the inability to show sufficient activity in clinical trials and the possibility of adverse regulatory actions. More information about the risks and uncertainties faced by Seagen is contained under the caption "Risk Factors" included in the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 filed with the Securities and Exchange Commission. Seagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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