Bristol Myers reports positive Phase III trial results of melanoma drug Opdivo

The randomized double blind trial included a total of 418 patients with treatment naïve BRAF wild-type unresectable Stage III and IV melanoma and they were given either Opdivo 3mg/kg every two weeks or DTIC 1000mg/m2 every three weeks.

The trial met the primary endpoint of overall survival (OS) with the median OS not reached for Opdivo versus 10.8 months for DTIC.

According to the company, safety was reported in all patients treated in the Opdivo and DTIC arms.

Designed in consultation with the Committee for Medicinal Products for Human Use (CHMP), the trial was primarily conducted in countries where DTIC is a commonly-used treatment in the first-line setting, including Canada, Europe and Australia, but not at US trial sites.

Bristol-Myers Squibb senior vice-president and head of Development, Oncology Michael Giordano said: "Results from this Phase III Opdivo trial with a survival endpoint build upon the pioneering science that led to the introduction of Yervoy in 2011 and underscore our strategic commitment to provide more patients with the potential opportunity for long-term survival.

"And, we continue to develop our immuno-oncology portfolio across the continuum of melanoma and multiple other cancers as single agents and as part of combination regimens."

BMS has proposed the name Opdivo, which, if approved by health authorities, will serve as the trademark for nivolumab.