Bristol-Myers Squibb to challenge Merck in skin cancer treatment arena, says GlobalData Analyst

Merck’s Keytruda, which was recently approved in the US to treat patients with advanced melanoma, who have stopped responding to other cancer therapies, will soon face strong competition from Bristol-Myers Squibb’s (BMS) Opdivo, says an analyst with research and consulting firm GlobalData.

Fenix Leung, DPhil, GlobalData’s Analyst covering Oncology and Hematology, states that Keytruda is the US’ first-to-market therapy that targets the programmed cell death receptor-1 (PD-1), better enabling the immune system to fight cancer.

However, the analyst notes that Merck should expect fierce competition in the race to first-line therapy development from BMS’ anti-PD-1 monoclonal antibody, Opdivo, which could receive approval from the European Medicines Agency for first-line melanoma treatment as early as Q2 2015.

Leung explains: “BMS stopped the CheckMate-066 trial early due to favorable results, and the Committee for Medicinal Products for Human Use (CHMP) granted accelerated assessment for Opdivo at the end of July. It is clear that BMS is working on a tight deadline to push Opdivo ahead of Keytruda in the EU.

“Keytruda is also likely to gain Food and Drug Administration approval as a first-line melanoma treatment in the US earlier than Opdivo. Since the latter is expected to reach the market a year after Keytruda, BMS may instead put forward a combination of Opdivo with Yervoy.”

Opdivo’s Phase III CheckMate-067 trial included an investigation of a Yervoy/Opdivo combination, which showed unmatched efficacy in a Phase 1b trial. The median overall survival of patients was 40 months, more than double that of either drug alone.

Leung comments: “Combination strategies are essential in the race to capture a large share of one of the most promising markets in cancer immunotherapy. However, toxicity remains a concern, as combining two immune response modulators could increase the frequency and severity of adverse drug reactions.

“Nonetheless, we will need to wait for the safety results from the CheckMate-067 trial, due in the fall of 2016, to gain an improved understanding of the Yervoy/Opdivo combination’s safety profile prior to approval in either the US or EU.”