Merck has secured approval from the US Food and Drug Administration (FDA) for its Keytruda to treat patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC).
Keytruda has been approved to treat patients with BCG- unresponsive, high-risk NMIBC with carcinoma in situ (CIS) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.
Keytruda, an anti-PD-1 therapy, works by enhancing the capability of the body’s immune system to help detect and combat tumour cells.
It is a humanised monoclonal antibody that inhibits the interaction between PD-1 and its ligands, PD-L1 and PD-L2, resulting in the activation of T lymphocytes that may affect both tumour cells and healthy cells.
The FDA has approved Keytruda for the new indication based on data from KEYNOTE-057 multicentre, open-label and single-arm trial, which recruited 96 patients with BCG-unresponsive NMIBC.
The trial does not include patients with muscle-invasive locally advanced non-resectable or metastatic urothelial carcinoma, concurrent extra-vesical non-muscle invasive transitional cell carcinoma of the urothelium, or autoimmune disease or a medical condition that required immunosuppression.
According to the company, the complete response, urine cytology, and computed tomography urography and duration of response are the major efficacy outcome measures of the trial.
Keytruda is currently being studied in over 1,000 trials across a wide variety of cancers and treatment settings.
Merck Research Laboratories clinical research vice president Dr Scot Ebbinghaus said: “Today’s approval of KEYTRUDA reinforces our company’s commitment to expanding existing treatment options for certain patients with high-risk, non-muscle invasive bladder cancer.
“As the first anti-PD-1 therapy approved in this setting, KEYTRUDA will be a new clinical option for a patient population that previously had limited FDA-approved therapies available.”
Keytruda plus Lenvima has been approved for the treatment of patients with advanced endometrial carcinoma, which is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Lenvima is the orally available kinase inhibitor discovered by Eisai.