SGEN Seagen Inc.

142.85
-1.62  -1%
Previous Close 144.47
Open 143.95
52 Week Low 117.91
52 Week High 213.94
Market Cap $25,899,543,672
Shares 181,305,871
Float 65,743,072
Enterprise Value $23,708,472,183
Volume 497,744
Av. Daily Volume 1,227,204
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Upcoming Catalysts

Drug Stage Catalyst Date
Tisotumab Vedotin
Cervical Cancer
PDUFA priority review
PDUFA priority review
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Drug Pipeline

Drug Stage Notes
Enfortumab vedotin - EV-202
Solid tumors
Phase 2
Phase 2
Phase 2 trial initiated January 2020.
Enfortumab Vedotin - EV-201
Urothelial Cancer
BLA Filing
BLA Filing
BLA filing announced February 28, 2021.
Enfortumab vedotin - EV-301
Urothelial cancer
BLA Filing
BLA Filing
BLA filing announced February 18, 2021.
Enfortumab vedotin and Keytruda EV-103
Urothelial cancer
Phase 1/2
Phase 1/2
Phase 1/2 Cohort K enrollment to be completed by end of 2021.
Tucatinib - MOUNTAINEER
HER2 amplified metastatic colorectal cancer
Phase 2
Phase 2
Phase 2 enrollment to be completed by end of 2021.
Tisotumab Vedotin (innovaTV 301)
Cervical Cancer
Phase 3
Phase 3
Phase 3 trial initiation announced January 5, 2021.
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
Urothelial cancer
Approved
Approved
FDA Approval announced December 18, 2019.
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. Company Announcement

    • FDA action date is Oct 10, 2021
    • BLA submission supported by positive pivotal innovaTV 204 trial results presented at the European Society of Medical Oncology Virtual Congress 2020

    COPENHAGEN, Denmark and BOTHELL, Wash.; April 09, 2021 – Genmab A/S (NASDAQ:GMAB) and Seagen Inc. (NASDAQ:SGEN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target…

    Company Announcement

    • FDA action date is Oct 10, 2021
    • BLA submission supported by positive pivotal innovaTV 204 trial results presented at the European Society of Medical Oncology Virtual Congress 2020

    COPENHAGEN, Denmark and BOTHELL, Wash.; April 09, 2021 – Genmab A/S (NASDAQ:GMAB) and Seagen Inc. (NASDAQ:SGEN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of Oct 10, 2021. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) directed to tissue factor (TF), a cell-surface protein expressed on multiple solid tumors including cervical cancer, and is associated with tumor growth, angiogenesis, metastasis and poor prognosis.1

    "We are pleased that the tisotumab vedotin BLA has been accepted with Priority Review by the FDA as there is an unmet need for effective therapies for women with recurrent or metastatic cervical cancer, who have disease progression on or after chemotherapy," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "This is an important milestone for Genmab as it brings us closer to our goal of bringing differentiated therapies to patients and transforming cancer treatment."

    The FDA's filing of the tisotumab vedotin BLA with Priority Review marks an important step forward for this ADC as a potential treatment for patients with recurrent or metastatic cervical cancer," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "We are collaborating closely with the FDA throughout the review process to make this important therapy available to patients."

    The BLA for tisotumab vedotin was submitted in February 2021. The submission is based on the results of the innovaTV 204 pivotal phase 2 single-arm clinical trial evaluating tisotumab vedotin as monotherapy in patients with previously treated recurrent or metastatic cervical cancer. These data were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

    About Cervical Cancer

    Cervical cancer originates in the cells lining the cervix. Over 13,500 women are expected to be diagnosed with invasive cervical cancer in the U.S. in 2020, with approximately 4,200 deaths.2 Cervical cancer remains one of the leading causes of cancer death in women globally, with over 311,000 women dying annually; the vast majority of these women being in the developing world.3 Routine medical examinations and human papillomavirus (HPV) vaccines have lowered the incidence of cervical cancer in the developed world. Despite these advances, women are still diagnosed with cervical cancer, which often recurs or becomes metastatic. Current therapies for previously treated recurrent or metastatic cervical cancer generally result in limited objective response rates of typically less than 15 percent with median overall survival ranging from 6.0 to 9.4 months.4-10

    About the innovaTV 204 Trial

    The innovaTV 204 trial (also known as GCT1015-04 or innovaTV 204/GOG-3023/ENGOT-cx6) is an ongoing single-arm, global, multicenter study of tisotumab vedotin for patients with recurrent or metastatic cervical cancer who were previously treated with doublet chemotherapy with or without bevacizumab. Additionally, patients were eligible if they had received up to two prior lines of therapy in the recurrent or metastatic setting. In the study, 101 patients were treated with tisotumab vedotin at multiple centers in the U.S. and Europe. The primary endpoint of the trial was confirmed objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by independent central review. Key secondary endpoints included duration of response, progression-free survival, overall survival, safety and tolerability.

    The study was conducted by Genmab in collaboration with Seagen, European Network of Gynaecological Oncological Trial Groups (ENGOT) and the Gynecologic Oncology Group (GOG) Foundation. For more information about the phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.

    About Tisotumab Vedotin

    Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) composed of Genmab's fully human monoclonal antibody specific for tissue factor and Seagen's ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody and releases it upon internalization, inducing target cell death. In cancer biology, tissue factor is a cell-surface protein and associated with tumor growth, angiogenesis, metastasis and poor prognosis.1 Based on its elevated expression in multiple solid tumors and its rapid internalization, tissue factor was selected as a target for an ADC approach. Tisotumab vedotin is being co-developed by Genmab and Seagen, under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.

    Tisotumab vedotin is being evaluated in a global phase 3, randomized clinical trial called innovaTV 301 versus investigator's choice of chemotherapy in recurrent or metastatic cervical cancer. The primary endpoint is overall survival and secondary endpoints include progression-free survival, duration of response, objective response rate, safety and tolerability. Enrollment is ongoing and the study is intended to support global registrations. In addition, tisotumab vedotin is being evaluated in ongoing clinical trials as monotherapy in recurrent or metastatic cervical cancer, ovarian cancer, and other solid tumors and in combination with commonly used therapies in recurrent or metastatic cervical cancer. These trials are evaluating tisotumab vedotin on a weekly or every three-week dosing schedule. More information about the innovaTV 301 clinical trial, including enrolling sites, as well as other ongoing clinical trials is available at www.clinicaltrials.gov.

    About Genmab

    Genmab is an international biotechnology company with a core purpose to improve the lives of patients with cancer. Founded in 1999, Genmab is the creator of multiple approved antibody therapeutics that are marketed by its partners. The company aims to create, develop and commercialize differentiated therapies by leveraging next-generation antibody technologies, expertise in antibody biology, translational research and data sciences and strategic partnerships. To create novel therapies, Genmab utilizes its next-generation antibody technologies, which are the result of its collaborative company culture and a deep passion for innovation. Genmab's proprietary pipeline consists of modified antibody candidates, including bispecific T-cell engagers and next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. The company is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com.



    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 our marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal on Twitter.

    Contact

    Genmab A/S:  

    Marisol Peron, Senior Vice President, Global Investor Relations & Communications

    T: +1 609 524 0065; E:

    For Investor Relations:

    Andrew Carlsen, Vice President, Head of Investor Relations

    T: +45 3377 9558; E:

    Seagen:

    Media and Investors:

    Peggy Pinkston, Senior Vice President, Investor Relations

    (425) 527-4160

    Genmab Forward Looking Statements

    This Company Announcement contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.



    Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. Kesimpta® is a trademark of Novartis AG or its affiliates. DARZALEX® and DARZALEX FASPRO® are trademarks of Johnson & Johnson. TEPEZZA® is a trademark of Horizon Therapeutics Ireland DAC.

    Seagen Forward Looking Statements

    Certain of the statements made in this press release are forward looking, such as those, among others, relating to the potential FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy based on the results of the innovaTV 204 trial, the timing of any potential FDA approval and the therapeutic potential of tisotumab vedotin. 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 without limitation the possibility that the Biologics License Application submission based on the innovaTV 204 trial may not be ultimately approved by the FDA in a timely manner or at all or with the requested label; that subsequent clinical trials may fail to establish sufficient efficacy; that adverse events or safety signals may occur; and that adverse regulatory actions may occur. More information about the risks and uncertainties faced by Seagen is contained under the caption "Risk Factors" included in the Company's Annual Report on Form 10-K for the year ended December 31, 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.

    References

    1 Rondon et al. Semin Thromb Hemost 2019; 45:396–412.

    2 National Cancer Institute SEER. "Cancer Stat Facts: Cervix Uteri Cancer." Available at https://seer.cancer.gov/statfacts/html/cervix.html. Last accessed April 2020.

    3 Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 countries https://www.iarc.fr/news-events/global-cancer-statistics-2018-globocan-estimates-of-incidence-and-mortality-worldwide-for-36-cancers-in-185-countries/.

    4 Miller et al., Gynecol Oncol 2008; 110:65.

    5 Bookman et al., Gynecol Oncol 2000; 77:446.

    6 Garcia et al., Am J Clin Oncol 2007; 30:428.

    7 Monk et al., J Clin Oncol 2009; 27:1069.

    8 Santin et al., Gynecol Oncol 2011; 122:495.

    9 Schilder et al., Gynecol Oncol 2005; 96:103

    10 Chung HC et al. J Clin Oncol 2019; 37:1470.



    Company Announcement no. 26

    CVR no. 2102 3884

    LEI Code 529900MTJPDPE4MHJ122

    Genmab A/S

    Kalvebod Brygge 43

    1560 Copenhagen V

    Denmark

    Attachment



    Primary Logo

    View Full Article Hide Full Article
    • FDA action date is Oct 10, 2021
    • BLA submission supported by positive pivotal innovaTV 204 trial results presented at the European Society of Medical Oncology Virtual Congress 2020

    Genmab A/S (NASDAQ:GMAB) and Seagen Inc. (NASDAQ:SGEN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of Oct 10, 2021. Tisotumab vedotin is an investigational…

    • FDA action date is Oct 10, 2021
    • BLA submission supported by positive pivotal innovaTV 204 trial results presented at the European Society of Medical Oncology Virtual Congress 2020

    Genmab A/S (NASDAQ:GMAB) and Seagen Inc. (NASDAQ:SGEN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of Oct 10, 2021. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) directed to tissue factor (TF), a cell-surface protein expressed on multiple solid tumors including cervical cancer, and is associated with tumor growth, angiogenesis, metastasis and poor prognosis.1

    "We are pleased that the tisotumab vedotin BLA has been accepted with Priority Review by the FDA as there is an unmet need for effective therapies for women with recurrent or metastatic cervical cancer, who have disease progression on or after chemotherapy," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "This is an important milestone for Genmab as it brings us closer to our goal of bringing differentiated therapies to patients and transforming cancer treatment."

    The FDA's filing of the tisotumab vedotin BLA with Priority Review marks an important step forward for this ADC as a potential treatment for patients with recurrent or metastatic cervical cancer," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "We are collaborating closely with the FDA throughout the review process to make this important therapy available to patients."

    The BLA for tisotumab vedotin was submitted in February 2021. The submission is based on the results of the innovaTV 204 pivotal phase 2 single-arm clinical trial evaluating tisotumab vedotin as monotherapy in patients with previously treated recurrent or metastatic cervical cancer. These data were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

    About Cervical Cancer

    Cervical cancer originates in the cells lining the cervix. Over 13,500 women are expected to be diagnosed with invasive cervical cancer in the U.S. in 2020, with approximately 4,200 deaths.2 Cervical cancer remains one of the leading causes of cancer death in women globally, with over 311,000 women dying annually; the vast majority of these women being in the developing world.3 Routine medical examinations and human papillomavirus (HPV) vaccines have lowered the incidence of cervical cancer in the developed world. Despite these advances, women are still diagnosed with cervical cancer, which often recurs or becomes metastatic. Current therapies for previously treated recurrent or metastatic cervical cancer generally result in limited objective response rates of typically less than 15 percent with median overall survival ranging from 6.0 to 9.4 months.4-10

    About the innovaTV 204 Trial

    The innovaTV 204 trial (also known as GCT1015-04 or innovaTV 204/GOG-3023/ENGOT-cx6) is an ongoing single-arm, global, multicenter study of tisotumab vedotin for patients with recurrent or metastatic cervical cancer who were previously treated with doublet chemotherapy with or without bevacizumab. Additionally, patients were eligible if they had received up to two prior lines of therapy in the recurrent or metastatic setting. In the study, 101 patients were treated with tisotumab vedotin at multiple centers in the U.S. and Europe. The primary endpoint of the trial was confirmed objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by independent central review. Key secondary endpoints included duration of response, progression-free survival, overall survival, safety and tolerability.

    The study was conducted by Genmab in collaboration with Seagen, European Network of Gynaecological Oncological Trial Groups (ENGOT) and the Gynecologic Oncology Group (GOG) Foundation. For more information about the phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.

    About Tisotumab Vedotin

    Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) composed of Genmab's fully human monoclonal antibody specific for tissue factor and Seagen's ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody and releases it upon internalization, inducing target cell death. In cancer biology, tissue factor is a cell-surface protein and associated with tumor growth, angiogenesis, metastasis and poor prognosis.1 Based on its elevated expression in multiple solid tumors and its rapid internalization, tissue factor was selected as a target for an ADC approach. Tisotumab vedotin is being co-developed by Genmab and Seagen, under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.

    Tisotumab vedotin is being evaluated in a global phase 3, randomized clinical trial called innovaTV 301 versus investigator's choice of chemotherapy in recurrent or metastatic cervical cancer. The primary endpoint is overall survival and secondary endpoints include progression-free survival, duration of response, objective response rate, safety and tolerability. Enrollment is ongoing and the study is intended to support global registrations. In addition, tisotumab vedotin is being evaluated in ongoing clinical trials as monotherapy in recurrent or metastatic cervical cancer, ovarian cancer, and other solid tumors and in combination with commonly used therapies in recurrent or metastatic cervical cancer. These trials are evaluating tisotumab vedotin on a weekly or every three-week dosing schedule. More information about the innovaTV 301 clinical trial, including enrolling sites, as well as other ongoing clinical trials is available at www.clinicaltrials.gov.

    About Genmab

    Genmab is an international biotechnology company with a core purpose to improve the lives of patients with cancer. Founded in 1999, Genmab is the creator of multiple approved antibody therapeutics that are marketed by its partners. The company aims to create, develop and commercialize differentiated therapies by leveraging next-generation antibody technologies, expertise in antibody biology, translational research and data sciences and strategic partnerships. To create novel therapies, Genmab utilizes its next-generation antibody technologies, which are the result of its collaborative company culture and a deep passion for innovation. Genmab's proprietary pipeline consists of modified antibody candidates, including bispecific T-cell engagers and next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. The company is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com.

    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 our marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal on Twitter.

    Genmab Forward Looking Statements

    This Company Announcement contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

    Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. Kesimpta® is a trademark of Novartis AG or its affiliates. DARZALEX® and DARZALEX FASPRO® are trademarks of Johnson & Johnson. TEPEZZA® is a trademark of Horizon Therapeutics Ireland DAC.

    Seagen Forward Looking Statements

    Certain of the statements made in this press release are forward looking, such as those, among others, relating to the potential FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy based on the results of the innovaTV 204 trial, the timing of any potential FDA approval and the therapeutic potential of tisotumab vedotin. 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 without limitation the possibility that the Biologics License Application submission based on the innovaTV 204 trial may not be ultimately approved by the FDA in a timely manner or at all or with the requested label; that subsequent clinical trials may fail to establish sufficient efficacy; that adverse events or safety signals may occur; and that adverse regulatory actions may occur. More information about the risks and uncertainties faced by Seagen is contained under the caption "Risk Factors" included in the Company's Annual Report on Form 10-K for the year ended December 31, 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.

    References

    1 Rondon et al. Semin Thromb Hemost 2019; 45:396–412.

    2 National Cancer Institute SEER. "Cancer Stat Facts: Cervix Uteri Cancer." Available at https://seer.cancer.gov/statfacts/html/cervix.html. Last accessed April 2020.

    3 Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 countries https://www.iarc.fr/news-events/global-cancer-statistics-2018-globocan-estimates-of-incidence-and-mortality-worldwide-for-36-cancers-in-185-countries/.

    4 Miller et al., Gynecol Oncol 2008; 110:65.

    5 Bookman et al., Gynecol Oncol 2000; 77:446.

    6 Garcia et al., Am J Clin Oncol 2007; 30:428.

    7 Monk et al., J Clin Oncol 2009; 27:1069.

    8 Santin et al., Gynecol Oncol 2011; 122:495.

    9 Schilder et al., Gynecol Oncol 2005; 96:103

    10 Chung HC et al. J Clin Oncol 2019; 37:1470.

    View Full Article Hide Full Article
  2. -Data Showcase Depth of Oncology Pipeline Using Seagen's Innovative Technologies-

    Seagen Inc. (NASDAQ:SGEN) today announced that preclinical data from its pipeline of novel targeted oncology drugs will be presented at the American Association for Cancer Research (AACR) Annual Meeting being held April 10-15, 2021. The oral and poster presentations will highlight several early-stage programs utilizing Seagen's leading antibody-drug conjugate (ADC) technology as well as its proprietary sugar-engineered antibody (SEA) technology.

    "Our research being presented at AACR describes intriguing preclinical data for three novel pipeline programs that are in ongoing clinical trials. This includes SEA-TGT, an anti-TIGIT antibody using our SEA technology…

    -Data Showcase Depth of Oncology Pipeline Using Seagen's Innovative Technologies-

    Seagen Inc. (NASDAQ:SGEN) today announced that preclinical data from its pipeline of novel targeted oncology drugs will be presented at the American Association for Cancer Research (AACR) Annual Meeting being held April 10-15, 2021. The oral and poster presentations will highlight several early-stage programs utilizing Seagen's leading antibody-drug conjugate (ADC) technology as well as its proprietary sugar-engineered antibody (SEA) technology.

    "Our research being presented at AACR describes intriguing preclinical data for three novel pipeline programs that are in ongoing clinical trials. This includes SEA-TGT, an anti-TIGIT antibody using our SEA technology, and two vedotin-based ADCs, SGN-B6A and SGN-STNV. We believe these three programs represent potential best-in-class or first-in-class targeted therapies for cancer," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "Among the findings, we will show the enhanced therapeutic effect in combining SEA-TGT with a checkpoint inhibitor or a vedotin-based ADC across different tumor models. In addition, we will report for the first time our preclinical data with SGN-STNV, a novel ADC targeting a carbohydrate antigen that may have broad applicability across solid tumors."

    Highlights of Seagen Programs Presented at AACR

    SEA-TGT

    Preclinical data will be presented for SEA-TGT, a novel investigational nonfucosylated human IgG1 TIGIT antibody, which utilizes Seagen's proprietary SEA technology that enhances functionality by targeting key immune activating Fc receptors. TIGIT is an inhibitory immune checkpoint that has emerged as a clinically relevant immuno-oncology target. The monotherapy and combinatorial activity of SEA-TGT was assessed and compared to TIGIT monoclonal antibodies (mAbs) with inert, standard, or effector function modified backbones in vivo and in vitro. Key preclinical findings were as follows:

    • the SEA-TGT backbone was distinct as it increased binding to activating FcγRIIIa with minimal binding to inhibitory FcγRIIb;
    • the empowered backbone had superior therapeutic properties including enhanced depletion of TIGIT-positive regulatory T-cells and activation of antigen-presenting cells both of which are important in promoting antitumor activity;
    • SEA-TGT demonstrated enhanced antitumor activity both as a single agent and in combination with anti-PD1 therapy; and,
    • SEA-TGT produced an enhanced therapeutic effect when combined with an immunogenic tumor cell death-inducing vedotin ADC.

    A phase 1 trial evaluating SEA-TGT alone and in combination with anti-PD-1 therapy in patients with advanced solid tumors and select lymphomas is ongoing.

    SGN-B6A

    Preclinical data will also be presented on SGN-B6A, an investigational ADC targeting integrin beta-6, which is overexpressed in numerous solid tumors and has been demonstrated to be a negative prognostic indicator across a diverse range of cancers, including non-small cell lung cancer (NSCLC). Data demonstrate SGN-B6A is active when dosed weekly in patient-derived xenograft models of NSCLC, representing both squamous and adenocarcinoma histology. A phase 1 trial evaluating monotherapy SGN-B6A in advanced solid tumors is ongoing.

    SGN-STNV

    SGN-STVN is an investigational ADC with a unique mechanism for targeting a carbohydrate antigen called Sialyl-Thomsen nouveau (STn), which is highly expressed on a variety of solid tumors including non-small cell lung, ovarian and gastric cancers. The preclinical data demonstrate SGN-STNV is highly specific for STn independent of protein identity, which could allow for the targeting of a range of tumor types that express different glycoproteins. In xenograft studies across key tumor types, the specificity and ability to target STn on multiple tumor-associated proteins led to durable tumor regressions. SGN-STNV was well-tolerated in in vivo studies and is being evaluated in an ongoing phase 1 study.

    Additional Details of Seagen Presentations at AACR Annual Meeting 2021

    All poster presentations will be available via on-demand view starting on April 10 at 8:30 a.m. Eastern Time. Oral symposium presentations will be available at the beginning of the session where the study is presented.

    Abstract Title

    Abstract #

    Date

    Presenter

    Oral

    Targeting Sialyl-Thomsen nouveau (STn) antigen with the SGN-STNV antibody-drug conjugate is effective in preclinical studies

    #50

    April 10 in session at 4:00 – 6:00 p.m. ET

    A. Schwartz

    E-Poster

    SEA-TGT is an empowered anti-TIGIT antibody that displays superior combinatorial activity with several therapeutic agents

    #1583

    April 10

    A. Smith

    Activity of SGN-B6A in patient-derived xenograft models of non-small cell lung cancer

    #914

    April 10

    R. Lyon

    Pharmacokinetics of tucatinib in healthy and hepatically-impaired volunteers

    #1371

    April 10

    A. Topletz-Erickson

    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 of the statements made in this press release are forward-looking, such as those, among others, relating to the potential of the Company's SEA-TGT, SGN-B6A and SGN-STNV product candidates, the enhanced therapeutic effect in combining SEA-TGT with a checkpoint inhibitor or a vedotin-based ADC and the potential of the Company's pipeline. 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 without limitation the difficulty and uncertainty of pharmaceutical product development, the risk of adverse events or safety signals, the inability to show sufficient efficacy 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 Annual Report on Form 10-K for the year ended December 31, 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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  3. Seagen Inc. (NASDAQ:SGEN) today announced that it will report its first quarter 2021 financial results on Thursday, April 29, 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 business update. Access to the event can be obtained as follows:

    Thursday, April 29, 2021
    1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

    • Telephone 844-763-8274 (U.S.) or +1 412-717-9224 (international); conference ID 10153242
    • 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…

    Seagen Inc. (NASDAQ:SGEN) today announced that it will report its first quarter 2021 financial results on Thursday, April 29, 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 business update. Access to the event can be obtained as follows:

    Thursday, April 29, 2021

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

    • Telephone 844-763-8274 (U.S.) or +1 412-717-9224 (international); conference ID 10153242
    • 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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  4. - Enfortumab vedotin to be reviewed under accelerated assessment for the treatment of locally advanced or metastatic urothelial cancer -

    Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. (NASDAQ:SGEN) today announced that a marketing authorization application (MAA) for enfortumab vedotin was accepted by the European Medicines Agency (EMA). The MAA requests review of enfortumab vedotin for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic…

    - Enfortumab vedotin to be reviewed under accelerated assessment for the treatment of locally advanced or metastatic urothelial cancer -

    Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. (NASDAQ:SGEN) today announced that a marketing authorization application (MAA) for enfortumab vedotin was accepted by the European Medicines Agency (EMA). The MAA requests review of enfortumab vedotin for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. If approved, enfortumab vedotin would be the first antibody-drug conjugate (ADC) available in the European Union for people living with urothelial cancer.

    Enfortumab vedotin will be reviewed under accelerated assessment, which means the EMA's Committee for Medicinal Products for Human Use (CHMP) can reduce the timeframe for evaluation.

    The MAA is based on the global phase 3 EV-301 trial, which evaluated enfortumab vedotin versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. Results from the trial, which had a primary endpoint of overall survival for patients treated with PADCEV versus chemotherapy, were published in the New England Journal of Medicine.

    "In the European Union, it is estimated that 118,000 people are diagnosed with urothelial cancer each year, and 52,000 die as a result of the disease," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas. "People with advanced urothelial cancer face an urgent need for new treatment options, which is reflected in the CHMP's decision to grant accelerated assessment. We will continue to work with the CHMP toward our goal of securing marketing authorization as soon as possible."

    About Urothelial Cancer

    Urothelial cancer is the most common type of bladder cancer (90 percent of cases), and can also be found in the renal pelvis (where urine collects inside the kidney), ureter (tube that connects the kidneys to the bladder) and urethra.1 Globally, approximately 549,000 new cases of bladder cancer and 200,000 deaths are reported annually.2 In Europe, it is estimated that 118,000 patients are diagnosed with this form of cancer and 52,000 deaths are reported annually.3

    Locally advanced and metastatic urothelial cancer is an aggressive disease that is associated with poor survival and high healthcare costs.4 Five-year relative survival rates for metastatic disease are estimated to be approximately 7 percent.5

    About the EV-301 Trial

    The EV-301 trial (NCT03474107) is a global, multicenter, open-label, randomized phase 3 trial designed to evaluate enfortumab vedotin versus physician's choice of chemotherapy (docetaxel, paclitaxel or vinflunine) in approximately 600 patients with locally advanced or metastatic urothelial cancer who were previously treated with a PD-1/L1 inhibitor and platinum-based therapies. The primary endpoint is overall survival and secondary endpoints include progression-free survival, overall response rate, duration of response and disease control rate, as well as assessment of safety/tolerability and quality-of-life parameters.6

    About Enfortumab Vedotin

    Enfortumab vedotin is an antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.7,8 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).8

    PADCEV (enfortumab vedotin-ejfv) U.S. Important Safety Information

    Warnings and Precautions

    Skin reactions: Severe cutaneous adverse reactions, including fatal cases of Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), occurred in patients treated with PADCEV. SJS and TEN occurred predominantly during the first cycle of treatment but may occur later.

    Skin reactions occurred in 54% of the 310 patients treated with PADCEV in clinical trials. Twenty-six percent (26%) of patients had maculopapular rash and 30% had pruritus. Grade 3-4 skin reactions occurred in 10% of patients and included symmetrical drug-related intertriginous and flexural exanthema (SDRIFE), dermatitis bullous, dermatitis exfoliative, and palmar-plantar erythrodysesthesia. In one clinical trial, the median time to onset of severe skin reactions was 0.8 months (range: 0.2 to 5.3). Of the patients who experienced rash, 65% had complete resolution and 22% had partial improvement.

    Monitor patients closely throughout treatment for skin reactions. Consider topical corticosteroids and antihistamines as clinically indicated. Withhold PADCEV and consider referral for specialized care for severe (Grade 3) skin reactions, suspected SJS, or TEN. Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions.

    Hyperglycemia occurred in patients treated with PADCEV, including death and diabetic ketoacidosis, in those with and without pre-existing diabetes mellitus. The incidence of Grade 3-4 hyperglycemia increased consistently in patients with higher body mass index and in patients with higher baseline A1C. In one clinical trial, 8% of patients developed Grade 3-4 hyperglycemia. Patients with baseline hemoglobin A1C ≥8% were excluded. Closely monitor blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia. If blood glucose is elevated (>250 mg/dL), withhold PADCEV.

    Peripheral neuropathy (PN), predominantly sensory, occurred in 49% of the 310 patients treated with PADCEV in clinical trials; 2% experienced Grade 3 reactions. In one clinical trial, peripheral neuropathy occurred in patients treated with PADCEV with or without preexisting peripheral neuropathy. The median time to onset of Grade ≥2 was 3.8 months (range: 0.6 to 9.2). Neuropathy led to treatment discontinuation in 6% of patients. At the time of their last evaluation, 19% had complete resolution, and 26% had partial improvement. Monitor patients for symptoms of new or worsening peripheral neuropathy and consider dose interruption or dose reduction of PADCEV when peripheral neuropathy occurs. Permanently discontinue PADCEV in patients that develop Grade ≥3 peripheral neuropathy.

    Ocular disorders occurred in 46% of the 310 patients treated with PADCEV. The majority of these events involved the cornea and included keratitis, blurred vision, limbal stem cell deficiency and other events associated with dry eyes. Dry eye symptoms occurred in 36% of patients, and blurred vision occurred in 14% of patients, during treatment with PADCEV. The median time to onset to symptomatic ocular disorder was 1.9 months (range: 0.3 to 6.2). Monitor patients for ocular disorders. Consider artificial tears for prophylaxis of dry eyes and ophthalmologic evaluation if ocular symptoms occur or do not resolve. Consider treatment with ophthalmic topical steroids, if indicated after an ophthalmic exam. Consider dose interruption or dose reduction of PADCEV for symptomatic ocular disorders.

    Infusion site extravasation: Skin and soft tissue reactions secondary to extravasation have been observed after administration of PADCEV. Of the 310 patients, 1.3% of patients experienced skin and soft tissue reactions. Reactions may be delayed. Erythema, swelling, increased temperature, and pain worsened until 2-7 days after extravasation and resolved within 1-4 weeks of peak. One percent (1%) of patients developed extravasation reactions with secondary cellulitis, bullae, or exfoliation. Ensure adequate venous access prior to starting PADCEV and monitor for possible extravasation during administration. If extravasation occurs, stop the infusion and monitor for adverse reactions.

    Embryo-fetal toxicity: PADCEV can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during PADCEV treatment and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PADCEV and for 4 months after the last dose.

    Adverse Reactions

    Serious adverse reactions occurred in 46% of patients treated with PADCEV. The most common serious adverse reactions (≥3%) were urinary tract infection (6%), cellulitis (5%), febrile neutropenia (4%), diarrhea (4%), sepsis (3%), acute kidney injury (3%), dyspnea (3%), and rash (3%). Fatal adverse reactions occurred in 3.2% of patients, including acute respiratory failure, aspiration pneumonia, cardiac disorder, and sepsis (each 0.8%).

    Adverse reactions leading to discontinuation occurred in 16% of patients; the most common adverse reaction leading to discontinuation was peripheral neuropathy (6%). Adverse reactions leading to dose interruption occurred in 64% of patients; the most common adverse reactions leading to dose interruption were peripheral neuropathy (18%), rash (9%) and fatigue (6%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common adverse reactions leading to dose reduction were peripheral neuropathy (12%), rash (6%) and fatigue (4%).

    The most common adverse reactions (≥20%) were fatigue (56%), peripheral neuropathy (56%), decreased appetite (52%), rash (52%), alopecia (50%), nausea (45%), dysgeusia (42%), diarrhea (42%), dry eye (40%), pruritus (26%) and dry skin (26%). The most common Grade ≥3 adverse reactions (≥5%) were rash (13%), diarrhea (6%) and fatigue (6%).

    Lab Abnormalities

    In one clinical trial, Grade 3-4 laboratory abnormalities reported in ≥5% were: lymphocytes decreased (10%), hemoglobin decreased (10%), phosphate decreased (10%), lipase increased (9%), sodium decreased (8%), glucose increased (8%), urate increased (7%), neutrophils decreased (5%).

    Drug Interactions

    Effects of other drugs on PADCEV Concomitant use with a strong CYP3A4 inhibitor may increase free MMAE exposure, which may increase the incidence or severity of PADCEV toxicities. Closely monitor patients for signs of toxicity when PADCEV is given concomitantly with strong CYP3A4 inhibitors.

    Specific Populations

    Lactation Advise lactating women not to breastfeed during treatment with PADCEV and for at least 3 weeks after the last dose.

    Hepatic impairment Avoid the use of PADCEV in patients with moderate or severe hepatic impairment.

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

    About the Astellas and Seagen Collaboration

    Astellas and Seagen Inc. are co-developing enfortumab vedotin under a 50:50 worldwide development and commercialization collaboration. In the United States, Astellas and Seagen co-promote enfortumab vedotin under the brand name PADCEV® (enfortumab vedotin-ejfv). In the Americas outside the US, Seagen holds responsibility for commercialization activities and regulatory filings. Outside of the Americas, Astellas holds responsibility for commercialization activities and regulatory filings.

    Astellas Cautionary Notes

    In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

    Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice.

    Seagen Forward Looking Statements

    Certain statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of enfortumab vedotin, including its efficacy, safety and therapeutic uses; and the potential to obtain regulatory approval of enfortumab vedotin in the European Union. 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, without limitation, the possibility that enfortumab vedotin may not ultimately be approved in the European Union for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting, in a timely manner or at all; and that setbacks in the development and commercialization of enfortumab vedotin could occur as a result of the difficulty and uncertainty of pharmaceutical product development, the risk of adverse events or safety signals, failure to establish sufficient efficacy in clinical trials, adverse regulatory actions or other factors. More information about the risks and uncertainties faced by Seagen is contained under the caption "Risk Factors" included in the company's Annual Report on Form 10-K for the year ended December 31, 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.

    References

    _______________________________

    1 American Society of Clinical Oncology. Bladder cancer: introduction. Published October 2017. https://www.cancer.net/cancer-types/bladder-cancer/introduction. Accessed March 4, 2021.

    2 Cancer today: data visualization tools for exploring the global cancer burden in 2020. https://gco.iarc.fr/today/home. Accessed March 4, 2021.

    3 Wong MC, Fung FD, Leung C, et al. Scientific Reports. 2018;8(1):1129.

    4 Shah MV, McGovern A, Hepp Z. Targeted Literature Review of the Burden of Illness in UC (PCN108). Value Health. 2018;21(3):S32-S33.

    5 von der Maase H, Sengelov L, Roberts J, Ricci S, et al. Long term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol. 2005;23(21):4602 8.

    6 Powles T, Rosenberg JE, Sonpavde GP, et al. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma. N Engl J Med. 2021; 10.1056/NEJMoa2035807.

    7 PADCEV [package insert]. Northbrook, IL: Astellas Pharma Inc.

    8 Challita-Eid P, Satpayev D, Yang P, et al. Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models. Cancer Res 2016;76(10):3003-13.

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