Major collaboration to evaluate enfortumab vedotin in combination with Keytruda

Japan’s Astellas Pharma (TYO:4503) and USA-based Seattle Genetics (Nasdaq: SGEN) have entered into a clinical collaboration agreement with pharma giant Merck & Co (NYSE: MRK) to evaluate the combination of their antibody-drug conjugate (ADC) enfortumab vedotin and Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), in patients with previously untreated metastatic urothelial (mostly bladder) cancer, adding to the string of clinical studies that are now evaluatiing already mega-blockbuster Keytruda with other drugs.

Under the terms of the accord, the three companies will conduct and fund a global, registrational Phase III clinical trial to be led by Seattle Genetics. The trial will be designed to evaluate the efficacy of the combination of enfortumab vedotin and pembrolizumab in patients with previously untreated locally advanced or metastatic urothelial cancer. The companies are working in consultation with regulatory authorities to finalize the trial design and currently plan to initiate the trial in the first half of 2020.

Enfortumab vedotin is currently under priority review by the US Food and Drug Administration for the treatment of patients with locally-advanced or metastatic urothelial cancer who have received a PD-1/L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. The PDUFA action date is March 15, 2020.