BMS' Opdivo and Yervoy ace kidney cancer trial

Bristol-Myers Squibb has halted a trial combining its two checkpoint inhibitors in a common form of kidney cancer early, after showing improved survival versus standard therapy.

The results of the CheckMate-214 come after earlier mixed results for the pairing of PD-1 inhibitor Opdivo (nivolumab) and CTLA4 blocker Yervoy (ipilimumab) in metastatic renal cell carcinoma (RCC), showing an improvement in response rate but failing to significantly improve progression-free survival (PFS).

Now - just a month later - data from the trial on overall survival shows a clear benefit for the combination compared to Pfizer's targeted RCC therapy Sutent (sunitinib), although BMS isn't giving away the details just yet.

The two drugs showed superior overall survival compared to Sutent in intermediate- and poor-risk patients - a co-primary endpoint in the trial - and also achieved a secondary endpoint of improving survival versus Pfizer's drug in all randomised patients. More details will be made available at the European Society for Medical Oncology (ESMO) congress this month.

The combination of Opdivo and Yervoy has already shown its worth in melanoma, with BMS claiming approval for that indication in 2015, but the missed PFS data in RCC, a delay in filing the two drugs in lung cancer plus a setback for AstraZeneca's rival PD-1/CTLA-4 duo Imfinzi (durvalumab) and tremelimumab in lung cancer had lowered expectations.

The new data put the programme back on track and could open up a new market for Opdivo worth $1bn-$2bn, according to analysts.

"This overall survival result from CheckMate-214 highlights the potential of the combination of Opdivo and Yervoy to provide a new treatment option for first-line advanced renal cell carcinoma patients for whom there is a considerable unmet need," said Vicki Goodman, head of new asset development at BMS. "The company looks forward to sharing the full results with regulatory authorities."

There was less encouraging news for BMS this week after the FDA slapped a partial hold on trials of Opdivo in multiple myeloma, a few weeks after taking a similar action against Merck & Co's Keytruda.

The partial hold - which means no new patients can be recruited into the trials but allows patients already enrolled to stay on therapy - affects three trials testing Opdivo in combination with other medicines.

In a statement, BMS said the FDA's action "is related to risks identified in trials studying [Keytruda] in patients with multiple myeloma", which prompted the FDA to place a full clinical hold on three of Merck's clinical studies in July.

The FDA is concerned about the risk associated with combining PD-1/PD-L1 inhibitors such as Keytruda and Opdivo with Celgene's Pomalyst (pomalidomide) or Revlimid (lenalidomide), two widely-used myeloma therapies.