FDA Advisory Committee recommends Keytruda for the treatment of certain patients with high-risk, non-muscle invasive bladder cancer (NMIBC).

Merck Inc. announced that the Oncologic Drugs Advisory Committee (ODAC) of the FDA voted 9-4 in favor of recommending Keytruda, Merck�s anti-PD-1 therapy, for the treatment of certain patients with high-risk, non-muscle invasive bladder cancer (NMIBC). The ODAC discussions were based on the supplemental Biologics License Application (sBLA), currently under priority review at the FDA, seeking approval of Keytruda monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, NMIBC with carcinoma in-situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy (removal of bladder). This application is based on results from the Phase II KEYNOTE-057 trial.

About KEYNOTE-057 : The FDA filing was based on data from KEYNOTE-057 (NCT02625961), a Phase II, multicenter, open-label, single-arm trial in 102 patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumors who were ineligible for or had elected not to undergo cystectomy (Cohort A). In this study, BCG-unresponsive high-risk NMIBC is defined as persistent disease despite adequate BCG therapy, disease recurrence after an initial tumor-free state following adequate BCG therapy, or T1 disease following a single induction course of BCG. Patients received Keytruda 200 mg every three weeks until unacceptable toxicity, persistent or recurrent high-risk NMIBC or progressive disease. Assessment of tumor status was performed every 12 weeks, and patients without disease progression could be treated for up to 24 months. The major efficacy outcome measures were complete response (as defined by negative results for cystoscopy [with transurethral resection of bladder tumor (TURBT)/biopsies as applicable], urine cytology, and computed tomography urography [CTU] imaging) and duration of response.

Comment: The Advisory Committee recommendation offers Keytruda the chance to become the first in the PD-1/L1 class to secure an FDA approval in NMIBC ahead of rivals including Bristol-Myers Squibb�s Opdivo, Roche�s Tecentriq and AstraZeneca�s Imfinzi, all of which are also under test in similar NMIBC settings.