10/31/2023 0 Comments Keynote 189 esmo 2022Pembrolizumab adverse events of special interest were consistent with previously observed safety data from monotherapy with the exception of severe skin reactions. All-grade treatment-related adverse events (TRAEs) of special interest for enfortumab vedotin in combination with pembrolizumab were skin reactions (67.1%), peripheral neuropathy (60.5%), ocular disorders (dry eye, blurred vision, and corneal disorders) (26.3%), hyperglycemia (14.5%), and infusion-related reactions (3.9%). The median duration of response (DOR) per BICR was not reached (95% CI: 10.25 months to NR). In patients treated with enfortumab vedotin and pembrolizumab (n=76), results demonstrated a 64.5% confirmed objective response rate (ORR) (95% CI: 52.7 to 75.1) per RECIST v1.1 by blinded independent central review (BICR), the primary endpoint of Cohort K, with 10.5% of patients experiencing a complete response and 53.9% of patients experiencing a partial response. The findings were presented today at the European Society for Medical Oncology (ESMO) Congress as part of a late-breaking abstract presentation (Abstract #LBA73).Īstellas stands on the forefront of healthcare change to turn innovative science into value for patients.(PRNewsFoto/Astellas Pharma Inc.) (PRNewswire) (Nasdaq:SGEN) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the phase 1b/2 EV-103 clinical trial (also known as KEYNOTE-869) Cohort K investigating PADCEV ® (enfortumab vedotin-ejfv) in combination with Merck's anti-PD-1 therapy 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. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas"), Seagen Inc. 12, 2022 /PRNewswire/ - Astellas Pharma Inc. – Data highlighted in late-breaking presentation at the European Society for Medical Oncology (ESMO) Congress 2022 – – Results demonstrated a 64.5% confirmed objective response rate in patients treated with investigational combination of enfortumab vedotin and pembrolizumab –
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