Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY), Seagen (NASDAQ:SGEN) and Merck (NYSE:MRK) said Padcev and Keytruda showed a 64.5% confirmed objective response rate (ORR) in patients with a type of urothelial cancer.
The companies presented data from a phase 1b/2 trial, dubbed EV-103 (also known as KEYNOTE-869), Cohort K evaluating Padcev (enfortumab vedotin-ejfv) in combination with Merck's Keytruda (pembrolizumab) and Padcev alone as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer (la/mUC) who are ineligible to receive cisplatin-based chemotherapy, at the 2022 European Society for Medical Oncology (ESMO) Congress.
In patients treated with Padcev/Keytruda (n=76) a 64.5% confirmed ORR was seen, the primary goal of Cohort K, with 10.5% of patients experiencing a complete response and 53.9% of patients seeing a partial response, the companies said in a Sept. 12 press release.
Among patients treated with the combo, median progression-free survival (PFS) was not reached, while median overall survival (OS) was 22.3 months.
All-grade treatment-related adverse events (TRAEs) of special interest for the combo were skin reactions (67.1%); peripheral neuropathy — damage to the nerves outside the brain and spinal cord — (60.5%), eye disorders (dry eye, blurred vision, and corneal disorders) (26.3%); hyperglycemia (high blood glucose) (14.5%); and infusion-related reactions (3.9%), the companies added.
Group K also included the monotherapy arm in which patients were treated with Padcev alone (n=73).
Data showed a 45.2% confirmed ORR, with 4.1% of patients experiencing a complete response and 41.1% of patients seeing a partial response, according to the companies.
The median duration of response (DOR) was 13.2 months. Median PFS was 8.0 months and median OS was 21.7 months.
All-grade TRAEs of special interest for Padcev were peripheral neuropathy (54.8%), skin reactions (45.2%), ocular disorders (28.8%), hyperglycemia (11.0%), and infusion-related reactions (5.5%), the companies noted.