KEYTRUDA and KEYTRUDA QLEX Approved to Treat Adults Patients with MIBC

The U.S. Food and Drug Administration has approved KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. These approvals represent the first PD-1 inhibitor plus ADC regimens for this patient population.

The approvals are based on data from the Phase III KEYNOTE-905 trial (also known as EV-303), which was conducted in collaboration with Pfizer and Astellas. Result showed that after a median follow-up of 25.6 months, KEYTRUDA plus Padcev, as perioperative treatment, demonstrated a statistically significant 60 percent reduction in the risk of event-free survival (EFS) events versus surgery alone in patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy. KEYTRUDA plus Padcev also demonstrated a statistically significant 50 percent improvement in overall survival versus surgery alone. The trial demonstrated a statistically significant difference in pathologic complete response rate. The effectiveness of KEYTRUDA QLEX for its approved indications has been established based upon evidence from the adequate and well-controlled studies conducted with KEYTRUDA and additional data from MK-3475A-D77 comparing the pharmacokinetic, efficacy and safety profiles of KEYTRUDA QLEX and KEYTRUDA.

“Pembrolizumab plus enfortumab vedotin is poised to address a critical unmet need,” said Matthew Galsky, MD, Lillian and Howard Stratton professor of medicine and director of genitourinary medical oncology at Mount Sinai Tisch Cancer Center, and KEYNOTE-905 study investigator. “Half of patients with MIBC may experience cancer recurrence even after having their bladder removed, and many of these patients are ineligible to receive cisplatin. These approvals, based on striking event-free and overall survival benefits, may represent an important practice-changing advance for these patients who’ve had no new options in decades.”