Phase II study for Opdivo (nivolumab)+Yervoy (ipilimumab) versus Yervoy monotherapy in untreated advanced melanoma- BMS

BMS has announced positive results from a Phase II trial (CheckMate -069), evaluating the Opdivo (nivolumab)+Yervoy (ipilimumab) regimen versus Yervoy alone in patients with previously untreated advanced melanoma. Patients with BRAF wild-type mutation status treated with the Opdivo+Yervoy regimen experienced a higher objective response rate (ORR) of 61% (n=44/72) – the primary study endpoint – compared to 11% (n=4/37) for patients administered Yervoy monotherapy (P<0.001). Complete responses were also reported in 22% (n=16) of patients with BRAF wild-type mutation status administered the Opdivo+Yervoy regimen and in no patients who received Yervoy monotherapy. Similar results were also observed in BRAF mutation-positive patients.

The safety profile was consistent with previously-reported studies evaluating the Opdivo+Yervoy regimen and included grade 3-4 colitis (17%), diarrhea (11%), and increased alanine aminotransferase (11%). These data will be presented at the American Association for Cancer Research (AACR) Annual Meeting and featured during a press briefing [Abstract #2860]. The results will also be published in The New England Journal of Medicine (NEJM).

Comment:Main competition for Opdivo, currently, is Keytruda (pembrolizumab) from Merck Inc. which has accelerated approval in the US for advanced melanoma. Keytruda has also demonstrated superiority over Yervoy in both overall survival and progression free survival in a first line melanoma study.

Opdivo has shown in Phase III data a 38% response with patients with previously treated melanoma which is superior to Keytuda producing a 24% overall response in a similar group of patients though baseline characteristics were different. Opdivo has accelerated approval in the US and is filed for metastatic melanoma in the EU.