BMS’ Opdivo gets a potential first-line boost in kidney cancer

pharmafile | September 8, 2017 | News story | Medical Communications, Research and Development |  Bristol-Myers Squibb, biotech, drugs, opdivo, pharma, pharmaceutical 

Bristol-Myers Squibb has announced results from a Phase 3 trial showing that patients treated with Opdivo alongside Yervoy in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) had met its co-primary endpoint. The major news being that the combination therapy was able to extend overall survival (OS) beyond that capable through treatment with standard chemotherapy, Pfizer’s Sutent (sunitinib).

The trial, CheckMate-214, was stopped as a result of the strength of data examined as part of interim analysis. The feedback from the trial showed that OS rate hit its co-primary endpoint with 41.6% against 26.5% for Pfizer’s treatment.

Successful results from this trial represent something of a comeback, after the combination had previously been shown to miss its other co-primary endpoint of improving progression-free survival (PFS). The treatment was only able to show a fractional improvement over Sutent, with 11.5 months of PFS against 8.3 months for Sutent – missing its predefined level of improvement.

“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, Bristol-Myers Squibb. “The company looks forward to sharing the full results with regulatory authorities and will incorporate these data into the planned European Society for Medical Oncology (ESMO) Congress presentation later this week.”

The next step will be to take the combination in front of the FDA to attempt to secure first-line treatment for RCC. Opdivo already possesses an indication to treat kidney cancer patients who have not shown a response to first-line treatment.

Should it gain approval, it would be a big fillip to the company in the immunotherapy field. It has been hit by several knockbacks, with the biggest coming in first-line lung cancer that pointed to its limitations as a monotherapy. This success should boost confidence that there is still ground to gain in the market, as well as putting an increased focus on whether Opdivo or Keytruda may benefit the most from results in combination treatments.

Shares in BMS bounced on the news, up close to 3% on the release of the news.

Ben Hargreaves