US regulators have assigned Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor Opdivo breakthrough status as a treatment for advanced kidney cancer, which could place the drug on a faster development pathway for this indication.
The move follows the success of late-stage clinical trial CheckMate-025, which assessed Opdivo (nivolumab) versus Novartis’ Afinitor (everolimus), the current standard of care, in previously treated advanced or metastatic clear-cell renal cell carcinoma.
The trial was stopped early in July after an analysis showed that the drug significantly improved overall survival compared to Afinitor, marking the first time an immunotherapy was shown to offer a survival advantage for this group of patients, whose treatment options remain limited.
RCC is the most common type of kidney cancer in adults, accounting for more than 100,000 deaths worldwide each year, and clear-cell forms are the most prevalent type, accounting for around 80%-90% of all cases.
Opdivo was approved in the US as a treatment for unresectable or metastatic melanoma in December last year, and for squamous non-small cell lung cancer the following March.