Merck's KEYTRUDA Plus Padcev Scores Positive EU CHMP Opinion
Pharmaceutical company Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on KEYTRUDA plus Padcev as a perioperative treatment for adults with resectable muscle-invasive bladder cancer. This recommendation is based on the results of the Phase 3 KEYNOTE-B15 trial, which showed that KEYTRUDA plus Padcev improved event-free survival by 47%, overall survival by 35%, and pathologic complete response rate compared to neoadjuvant chemotherapy and surgery. The CHMP's opinion will now be reviewed by the European Commission for marketing authorization in the EU.
If approved, KEYTRUDA plus Padcev would become the first and only PD-1 inhibitor plus antibody-drug conjugate regimen for patients with MIBC regardless of cisplatin eligibility in the European Union. Dr. Marjorie Green, senior vice president, oncology, global clinical development at Merck Research Laboratories, said that despite advances in muscle-invasive bladder cancer treatment, recurrence remains a significant concern for many patients.
KEYTRUDA is an anti-PD-1 therapy developed by Merck, while Padcev is an antibody-drug conjugate. The trial showed that KEYTRUDA plus Padcev demonstrated a statistically significant improvement in event-free survival, overall survival and pathologic complete response rate compared to neoadjuvant chemotherapy (gemcitabine and cisplatin) and surgery.