Studies Supporting Opdivo’s sBLA for Renal Cell Carcinoma

Bristol Myers Squibb’s Opdivo sBLA Accepted for Priority Review

(Continued from Prior Part)

Studies that support Opdivo’s sBLA

Bristol-Myers Squibb’s (BMY) Opdivo is a programmed death 1 (or PD-1) inhibitor that is already approved by the U.S. Food and Drug Administration, or FDA, for two types of cancer—melanoma and advanced non-small cell lung cancer, or NSCLC. The FDA has accepted Opdivo’s supplemental biologics license application, or sBLA, for renal cell carcinoma, or RCC. The approval is based on the results of a phase III study named Checkmate-025, according to BMY’s press release on November 16, 2015.

Details about Checkmate-025 study

According to BMY’s press release, Checkmate-025 was a phase III study that compared Opdivo with everolimus on overall survival, ORR (objective response rate), and PFS (progression-free survival). In this study, the total sample size was ~800 patients who had already been treated for advanced or metastatic RCC. The patients were given either a dose of 3mg/kg of Opdivo intravenously every two weeks or a 10mg tablet of everolimus on a daily basis. The study was continued until researchers observed disease progression or unacceptable toxicity. The primary end point was overall survival rate, while the secondary end points were PFS and ORR.

The study was stopped in July 2015 following an assessment that revealed superior overall survival in patients who received Opdivo.

Further developments for Opdivo

According to BMY’s press release on November 5, 2015, the European Medicines Agency (EMA) approved BMY’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.

In its press releases, BMY has also discussed the broad global development program to study Opdivo in multiple tumor types. There are more than 50 clinical trials under process for use of Opdivo in various anticancer treatments. All these programs are listed under the Checkmate series and are studying Opdivo as a monotherapy or a combination treatment.

Drugs for melanoma and NSCLC include Merck’s (MRK) Keytruda, GlaxoSmithKline’s (GSK) Mekinist and Tafinlar, and Roche’s Zelboraf, while existing drugs for renal cell carcinoma include Genentech’s Avastin, Pfizer (PFE) Inlyta and Sutent, and Bayer HealthCare Pharmaceuticals’ Nexavar.

To diversify risk, investors can consider ETFs such as the Market Vectors Pharmaceutical ETF (PPH), which holds ~5.3% of its total portfolio in Bristol-Myers Squibb, or the iShares US Pharmaceuticals ETF (IHE).

Continue to Next Part

Browse this series on Market Realist:

• Part 1 - Opdivo’s sBLA Accepted by FDA for Priority Review

• Part 3 - Market Response to the FDA’s Acceptance of Opdivo’s sBLA

• Part 4 - Existing Drugs for Renal Cell Carcinoma