– Results from EV-103 trial evaluating PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) in urothelial cancer to be featured as late-breaking oral session –
BOTHELL, Wash., September 07, 2022--(BUSINESS WIRE)--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
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)
Oral Presentation / Proffered Paper Session 2: GU Tumours, Non-prostate, September 12,
Additional analyses of MOUNTAINEER: A phase 2 study of tucatinib and trastuzumab for HER2-positive mCRC
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
Poster Session 7, September 11, 12:00-13:00 CEST
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)
Poster Session 8, September 11, 12:00-13:00 CEST
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)
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
Poster Session 8, September 11, 12:00-13:00 CEST
T. S. Bekaii-Saab
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.
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.
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Douglas Maffei, Ph.D.