Seagen Inc. 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.