Bristol-Myers Squibb’s Phase III trial of Opdivo meets primary end point

17th November 2014 (Last Updated November 17th, 2014 18:30)

Bristol-Myers Squibb has reported positive results from a Phase III trial (CheckMate -066) comparing an investigational PD-1 immune checkpoint inhibitor, Opdivo, to the chemotherapy dacarbazine (DTIC) in patients with treatment naïve BRAF wild-type advanced melanoma.

Bristol-Myers Squibb has reported positive results from a Phase III trial (CheckMate -066) comparing an investigational PD-1 immune checkpoint inhibitor, Opdivo, to the chemotherapy dacarbazine (DTIC) in patients with treatment naïve BRAF wild-type advanced melanoma.

A total of 418 patients with treatment naïve BRAF wild-type unresectable Stage III and IV melanoma were enrolled in the trial and they were randomised to receive either Opdivo 3mg/kg every two weeks or DTIC 1000mg/m2 every three weeks.

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

The company said that the one-year survival rate was 73% for Opdivo versus 42% for DTIC and there was a 58% decrease in the risk of death for patients treated with Opdivo.

"A total of 418 patients with treatment naïve BRAF wild-type unresectable Stage III and IV melanoma were enrolled in the trial and they were randomised to receive either Opdivo 3mg/kg every two weeks or DTIC 1000mg/m2 every three weeks."

Institute Gustave Roussy professor of Dermatology and head of the Dermatology Unit Caroline Robert said: "The results from CheckMate -066 are significant as they represent the first time a PD-1 immune checkpoint inhibitor has shown a survival benefit in a randomised Phase III trial.

"This represents a major milestone in the study of treatment naïve patients with wild-type BRAF advanced melanoma."

The company said that in the trial, safety was reported in all patients treated in the Opdivo and DTIC arms.

The trial, designed in consultation with the Committee for Medicinal Products for Human Use (CHMP), 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."

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