- New data on Bristol-Myers Squibb's Opdivo bolstered evidence of the cancer immunotherapy's long-term benefit, with more than a third of melanoma patients who received the therapy surviving at least five years, the company said on Sunday.
- The Phase 1b study included 107 heavily pre-treated patients with advanced melanoma, 34% of whom survived past five years. Typically, survival rates for the five-year mark are around 15% - 20% in advanced patients, according to the company.
- Additionally, Bristol-Myers reported results from a phase 2 combination trial of Opdivo and its other immunotherapy Yervoy which showed higher two-year overall survival rates than treatment by Yervoy alone.
The new data should help Bristol-Myers in its battle for anti-PD1 market share against Merck's Keytruda. Although Merck beat Bristol-Myers to regulatory approval by several months, Opdivo has racked up new indications and outpaced Keytruda in 2015 sales.
Consensus expectations put annual sales for Opdivo at $11.1 billion by 2020, according to a Reuters report from February. The durability of responses shown in the five-year study of Opdivo against previously-treated melanoma will shore up those forecasts.
“These data contribute to our growing understanding of this aggressive cancer and are promising news for advanced melanoma patients. In particular, we are seeing further data that evaluate the potential survival benefit of the nivolumab and ipilimumab combination,” said F. Stephen Hodi, director of the Melanoma Center at Dana-Farber Cancer Institute, using the generic names for Opdivo and Yervoy.
In the Checkmate study, 142 patients with BRAF wild-type/BRAF V600 melanoma received either a combination of Opdivo and Yervoy, or Yervoy alone. After two years, patients taking the combo had a overall survival rate of 69%, compared to 53% for those only receiving Yervoy.
The safety profile of the drugs was similar to previously reported studies.
As Bristol-Myers and Opdivo fight for the top spot in the anti-PD1 space, others are trying to catch up. Roche's atezolizumab recently won priority review status from the FDA for the treatment of NSCLC and the agency plans to decide on approval by October 19.
However, atezolizumab is being considered for approval in conjunction with a companion diagnostic test to determine PD-L1 expression. This is similar to Keytruda's current approval and has proven to be an edge for Opdivo, which doesn't carry the same diagnostic requirement.
AstraZeneca is also moving forward with its bladder cancer candidate durvalumab, despite some setbacks last year.