All articles tagged with #padcev
Merck announced positive results from the Phase 3 KEYNOTE-B15 trial showing that combining KEYTRUDA (pembrolizumab) with Padcev (enfortumab vedotin) before and after surgery significantly improves survival and response rates in cisplatin-eligible muscle-invasive bladder cancer patients, with a safety profile consistent with known effects.
Pfizer's stock rose by 1.6% after the FDA approved the expanded use of Padcev, an antibody-drug conjugate (ADC), in combination with Merck's Keytruda for the treatment of advanced bladder cancer. This marks the first approval for a combination of an ADC product plus PD-L1 inhibitor for this indication, offering an alternative to platinum-containing chemotherapy. The approval was based on data from a phase III study showing that the combination nearly doubled overall survival and progression-free survival compared to chemotherapy. Pfizer's acquisition of Seagen, which added ADC technology to its portfolio, is expected to strengthen its position in the oncology market.
The combination of Seagen and Astellas Pharma's Padcev with Merck's Keytruda has been hailed as the "new standard of care" in first-line bladder cancer, according to confirmatory trial data presented at the European Society for Medical Oncology (ESMO) conference. The combination therapy demonstrated significantly improved overall survival and progression-free survival compared to chemotherapy, potentially expanding the eligible patient population.
Seagen and Merck's combination therapy of Padcev and Keytruda has received FDA accelerated approval for the first-line treatment of bladder cancer in patients who are ineligible for cisplatin-containing chemotherapy. The approval is based on positive data from a multi-cohort study, and analysts estimate that the market for cisplatin-ineligible urothelial carcinoma is worth $2.5 billion to $3 billion globally. The approval could potentially push Padcev into a multibillion-dollar market just as Pfizer prepares to acquire Seagen for $43 billion.