FDA ushers Merck's star cancer drug Keytruda toward another key checkpoint
Merck counts 22 approved indications for Keytruda across 14 different cancer types. It is now being ushered toward one more.
The PD-1 blockbuster has been granted priority review for another set of bladder cancer patients: those with high-risk non-muscle invasive bladder cancer (NIMBC) who haven’t undergone cystectomies and are resistant to the standard treatment. The biologics license application will be discussed at the FDA oncology drug meeting on December 17, Merck said, and has a PDUFA date for next month, January 2020.
The expedited review is based on KEYNOTE-057, a single-arm Phase II study that found 40 out of 102 patients had a complete response at three months. Of those, 29 (72.5%) remained tumor-free through the last check-up at 14 months. Data were not presented on partial responses.
The news comes two months after the hype around Roche’s self-vaunted Phase III data on Tecentriq in bladder cancer was batted down by the company’s own investigators.
For once, though, Merck might not find itself with the most eye-catching cancer drug approaching approval. Last week, Ferring spun out a biotech built around a gene therapy that uses an adenovirus to deliver the cancer-suppressing gene interferon alfa-2b into bladder walls. FerGene, as the new company is known, hasn’t announced a PDUFA date, but the drug also has priority review and the biotech has $570 million in backing.
Keytruda first gained approval in a bladder cancer, advanced urothelial carcinoma, in 2017. That indication was almost rejected by UK health authority NICE, though, who saw it as potentially too costly for an end-of-life treatment but ultimately okayed the drug in 2018.
Bladder cancer has long been treated by an older form of immunotherapy: Bacillus Calmette-Guérin, a bacterial strain commonly used as a tuberculosis vaccine, and which appears to trigger an immune response in the bladder that can affect tumors. NIMBC patients represent 75% of the annual 80,000 new bladder cancer cases in the US, according to company-cited estimates.