BMS Stops Phase III Opdivo Trial for RCC

Bristol-Myers Squibb cut short a Phase 3 study of Opdivo for the treatment of renal cell carcinoma after the immunotherapy drug met its primary endpoint versus everolimus, the current standard treatment.

The results mark the first time an immuno-oncology agent has demonstrated a survival advantage in advanced RCC, the drugmaker says. The secondary endpoints were objective response rate and progression-free survival.

A BMS spokeswoman says the company will share the trial data with the FDA soon, but didn’t give a timeframe for filing an sNDA for Opdivo as a first-line treatment for RCC.

This is the second Opdivo trial BMS has stopped early due to the drug meeting its primary endpoint. In April, it showed clear benefit over chemotherapy in treating advanced nonsquamous non-small cell lung cancer.

Opdivo already has two FDA-approved indications — the most recent issued in March for treating metastatic squamous non-small cell lung cancer that has progressed after chemotherapy. The drug’s was initially approved in December for melanoma.

Opdivo is one of a new class of immunological cancer drugs called PD-1 inhibitors, which block a protein that keeps the immune system from recognizing and attacking cancer cells. The only other PD-1 inhibitor on the market is Merck’s Keytruda (pembrolizumab). That drug also had a trial halted this past spring, after it increased survival rates in advanced melanoma patients. — Kellen Owings