On September 7, 2022 Seagen Inc. (Nasdaq:SGEN) reported upcoming presentations of new data from its clinical development programs at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022, to be held September 9-13 in Paris, France (Press release, Seagen, SEP 7, 2022, View Source [SID1234619155]). 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.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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 (Free ESMO Whitepaper) 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