CheckMate -025 Study Supports Opdivo’s Approval


Nov. 27 2015, Updated 6:08 a.m. ET

Opdivo approved for renal cell carcinoma

Bristol-Myers Squibb’s (BMY) Opdivo is a programmed cell death protein 1 (or PD-1) inhibitor. It is already approved by the FDA for two cancer indications, melanoma and advanced NSCLC (non-small cell lung cancer).

The FDA has now approved Opdivo for the treatment of advanced RCC (renal cell carcinoma) based on the results of a phase 3 study called CheckMate -025, announced in Bristol-Myers Squibb’s press release on November 23, 2015. The FDA has also approved Opdivo for the treatment of BRAF wild-type melanoma, which we’ll discuss later in this series.

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Details of CheckMate -025 study

According to the company’s press releases, the CheckMate -025 study is a phase 3 study that compared the overall survival, ORR (objective response rate), and PFS (progression-free survival) of Opdivo with that of another drug, everolimus. This study focused on ~800 patients who had already been treated for advanced or metastatic RCC. The patients were given either a dose of Opdivo intravenously every two weeks or an everolimus tablet daily. The study was continued until there was some disease progression observed or there was unacceptable toxicity.

The study was completed in July 2015 following an assessment that revealed superior overall survival for patients receiving Opdivo, with a median overall survival benefit of 25 months, against 19.6 months for patients receiving everolimus. The safety profile was consistent with previous Opdivo studies.

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Further developments for Opdivo

According to the company’s press release on November 5, 2015, the EMA (European Medicines Agency) approved Bristol-Myers Squibb’s type II variation application for Opdivo based on the overall results from the CheckMate -025 study. This validation was for the use of Opdivo in previously treated advanced renal cell carcinoma. Investors can read Existing Drugs for Renal Cell Carcinoma for more information.

Opdivo competes with drugs such as Pfizer’s (PFE) Inylta and Sutent, Bayer’s Nexavar, Merck’s (MRK) Keytruda, GlaxoSmithKline’s (GSK) Mekinist and Tafinlar, and Roche’s Zelboraf. Investors can consider ETFs such as the iShares US Pharmaceuticals ETF (IHE), which holds ~7.6% of its total investments in Bristol-Myers Squibb.



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