Business Wire

Seagen to Highlight Research in Urothelial and Colorectal Cancers at 2022 European Society for Medical Oncology (ESMO) Congress

Share

Seagen Inc. (Nasdaq:SGEN) today announced upcoming presentations of new data from its clinical development programs at the European Society for Medical Oncology (ESMO) Congress 2022, to be held September 9-13 in Paris, France. One of two late-breaking oral presentations will feature results from Cohort K of EV-103 (also known as KEYNOTE-869), a phase 1b/2 clinical trial conducted in partnership with Astellas. Cohort K is evaluating PADCEV® (enfortumab vedotin-ejfv) as monotherapy or in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer (la/mUC) who are ineligible to receive cisplatin-based chemotherapy. Merck is known as MSD outside the United States and Canada.

A second late-breaking oral presentation will include additional results from the phase 2 MOUNTAINEER trial evaluating TUKYSA® (tucatinib) in combination with trastuzumab in patients with previously treated HER2-positive metastatic colorectal cancer (mCRC). Patient-reported outcomes from MOUNTAINEER also will be detailed in a separate presentation. Data from the MOUNTAINEER trial formed the basis of a supplemental New Drug Application submitted to the U.S. Food and Drug Administration (FDA) under the Accelerated Approval Program. On July 28, 2022, the FDA granted Breakthrough Therapy Designation for tucatinib in combination with trastuzumab for the treatment of adult patients with unresectable or metastatic HER2-positive CRC who have previously received fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy. The designation is based on results from the MOUNTAINEER trial.

“These important data to be shared at the ESMO Congress reflect our commitment to develop innovative solutions for patients with challenging clinical needs in cancer,” said Marjorie Green, M.D., Senior Vice President and Head of Late-Stage Development at Seagen.

Presentations of Company-Sponsored Trials

ABSTRACT TITLE

PRESENTATION #

PRESENTATION TYPE

LEAD AUTHOR

PADCEV® (enfortumab vedotin-ejfv)

Study EV-103 Cohort K: Antitumor activity of enfortumab vedotin (EV) monotherapy or in combination with pembrolizumab (P) in previously untreated cisplatin-ineligible patients (pts) with locally advanced or metastatic urothelial cancer (la/mUC)

LBA73

Oral Presentation / Proffered Paper Session 2: GU Tumours, Non-prostate, September 12,

14:55-15:05 CEST

J. Rosenberg

TUKYSA® (tucatinib)

Additional analyses of MOUNTAINEER: A phase 2 study of tucatinib and trastuzumab for HER2-positive mCRC

LBA27

Mini Oral Presentation / Mini Oral Session: GI, Lower Digestive, September 12, 14:50-14:55 CEST

J. H. Strickler

Tucatinib plus trastuzumab in patients (Pts) with HER2-positive metastatic colorectal cancer (mCRC): Patient-reported outcomes (PROs) from ph 2 study MOUNTAINEER​

361P

Poster Session 7, September 11, 12:00-13:00 CEST

C. Wu

TUKYSA® (tucatinib) Trials in Progress

MOUNTAINEER-03: Phase 3 study of tucatinib, trastuzumab, and mFOLFOX6 as first-line treatment in HER2+ metastatic colorectal cancer (trial in progress)

438TiP

Poster Session 8, September 11, 12:00-13:00 CEST 

T. André 

Disitamab vedotin Trials in Progress

Phase 2 clinical study evaluating the efficacy and safety of disitamab vedotin in patients (pts) with HER2-expressing urothelial carcinoma (RC48G001, trial in progress)

1779TiP

Poster Session 12, September 12, 12:00-13:00 CEST

V. S. Koshkin

Health Economics and Outcomes Research

Impact of anti-EGFR therapies on HER2-positive metastatic colorectal cancer (HER2+ mCRC): A systematic literature review and meta-analysis of clinical outcomes

376P

 Poster Session 8, September 11, 12:00-13:00 CEST

T. S. Bekaii-Saab 

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.

Forward-Looking Statements

Certain statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of PADCEV, TUKYSA, disitamab vedotin and the company’s other products and product candidates, including their potential efficacy, safety and therapeutic uses, and the potential for TUKYSA to receive accelerated approval from the FDA based on data from the MOUNTAINEER trial. 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 data from the MOUNTAINEER trial and other trials may not be sufficient to support any regulatory approvals; the risk of adverse events, including the potential for newly-emerging safety signals; adverse regulatory actions; delays, setbacks or failures in clinical development activities, the submission of regulatory applications and the regulatory review process for a variety of reasons, including the difficulty and uncertainty of pharmaceutical product development. 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 year ended June 30, 2022 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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

For Media
David Caouette
(310) 430-3476
dcaouette@seagen.com

For Investors
Douglas Maffei, Ph.D.
(425) 527-4881
dmaffei@seagen.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

H.I.G. Capital Announces the Sale of DGS S.p.A.11.6.2024 12:00:00 CEST | Press release

H.I.G. Capital (“H.I.G.”), a leading global alternative investment firm with $62 billion of capital under management, is pleased to announce that an affiliate has signed a definitive agreement to sell its portfolio company, DGS S.p.A. (“DGS” or the “Group”), a leading firm in the Italian Information Technology market, to DGS Co-Founders and management team in partnership with ICG, a global alternative asset manager. Since its inception in 1997, DGShas supported blue-chip customers in the design, integration, and maintenance of complex IT systems, with a specialization in digital transformation and cybersecurity services. The Group currently has over 1,900 employees, revenues of approximately €300 million, and maintains a group of highly loyal clientele. During H.I.G.’s ownership, DGS has tripled in size and consolidated its position as a leading Italian firm in cybersecurity services and digital transformation. DGS offers its clients sophisticated and proprietary digital transformation

Evertas Names Nick Selby Head of European Underwriting11.6.2024 12:00:00 CEST | Press release

Evertas, the world’s first crypto insurance company, has named Nick Selby as its new Head of European Underwriting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240611141887/en/ Nick Selby, Executive Vice President and Head of European Underwriting at Evertas (Photo: Business Wire) Selby, an accomplished information and physical security professional, brings two decades of expertise in public and private sector information security, physical security, and complex incident handling, as well as seven years of experience leading teams securing billions of dollars in cryptoassets. Previously, his roles included VP of the Software Assurance Practice at Trail of Bits, Chief Security Officer at Paxos Trust Company, and Director of Cyber Intelligence and Investigations at the NYPD Intelligence Bureau. “Nick is an extremely valuable addition to our European team,” said Evertas CEO and Co-Founder J. Gdanski. “His public and private

Owlet utvider globalt fotavtrykk med lanseringen av medisinsk-sertifisert Dream Sock™ i Storbritannia og over hele Europa11.6.2024 11:00:00 CEST | Pressemelding

Owlet, Inc. («Owlet» or the «Company») (NYSE:OWLT), pioneren innen smart spedbarnsovervåking, kunngjør i dag den britiske og europeiske lanseringen av Dream Sock. Dette er en smart babymonitor med levende helseavlesninger og varsler for friske spedbarn mellom 0-18 måneder og 2,5-13,6 kg. Dette innovative medisinske utstyret gir foreldre helse og viktig informasjon i sanntid, noe som gir uovertruffen trygghet. Denne pressemeldingen inneholder multimedia. Se hele pressemeldingen her: https://www.businesswire.com/news/home/20240611820341/no/ (Photo: Business Wire) «Vi er svært stolte over å lansere Dream Sock til omsorgspersoner over hele Storbritannia og Europa og gi millioner av foreldre mer trygghet mens babyen sover,» sa Kurt Workman, Owlets administrerende direktør og medgründer. «Dream Sock er nå et globalt produkt som er anerkjent som medisinsk nøyaktig og trygt, etter å ha gjennomgått regulatoriske autorisasjoner og sertifiseringer innenfor flere geografier. I dag er misjonen vår

V-Nova Surpasses 1000 Patent Milestone in Media Technology Innovation11.6.2024 10:00:00 CEST | Press release

V-Nova, a leading provider of data compression solutions, video compression technology, XR technology, AI acceleration and parallel processing for a multitude of industries including media and entertainment, today announced its milestone achievement of 1000 active technology patents. This accomplishment underscores V-Nova’s dedication to research and development and its commitment to protecting its intellectual property globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240611724561/en/ V-Nova’s patent portfolio spans more than 50 different jurisdictions. Including over 400 patents in Europe, over 200 in the Americas, over 100 in the United States specifically, and over 200 in Asia. V-Nova forged new directions in data processing to enhance digital experiences, maximize efficiency, reduce costs, and increase sustainability. The company leads the way with key international data compression standards for the video indust

Alipay+ Reveals Top Scorer Trophy Design for UEFA EURO 2024™11.6.2024 09:24:00 CEST | Press release

Alipay+, a suite of cross-border mobile payment and digitalization technology solutions operated by Ant International and an Official Partner of UEFA EURO 2024™, today revealed the trophy that will be awarded to the most prolific marksman at the UEFA EURO 2024™ finale on July 14 in Berlin, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240610328619/en/ The UEFA Top Scorer Trophy presented by Alipay+ is unveiled for UEFA EURO 2024™ (Photo: Business Wire) Sculpted in the shape of the Chinese character “支” (pronounced zhi, and meaning payment as well as support), the trophy reflects Alipay+’s dedication to supporting consumers to enjoy seamless payment and a broad choice of deals using their preferred payment methods while traveling abroad. The character also resembles the fleeting moment of a barefooted striker poised to shoot, evoking the original beauty and power of football – a game that united people across the wo

World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye