Bristol-Myers Squibb’s ($BMY) Opdivo appears on its way toward an approval in yet another form of cancer after demonstrating more impressive survival rates, this time for patients with the aggressive and fatal advanced head and neck cancer. It showed that more than a third of patients taking the immuno-oncology drug for advanced cancer were still alive at a year when the overall survival average is 6 months.
The data was released less than a week after Merck’s ($MRK) competing immuno-oncology drug Keytruda was put on track for an FDA priority review for treating head and neck cancer, setting it up for approval by August.
In the Opdivo study of 361 patients, which investigators were able to end early, the PD-1 inhibitor extended the median survival rate of cancer patients to 7.5 months compared to 5.1 months for those on any one of three standard of care treatments, BMS said.
More importantly, lead investigator Dr. Maura Gillison told Reuters, the study found that 36% of patients taking Opdivo for the head and neck cancer lived for at least 12 months.
"The most important thing is the difference in the proportion of patients who survived to a year," Dr. Gillison, who presented the data Tuesday at the American Association of Cancer Research meeting in New Orleans, told the news service. "In a disease that was uniformly rapidly fatal, we're seeing a subset of the population clearly benefiting."
The study found that Opdivo was effective regardless of whether the head and neck cancer was positive or negative for human papillomavirus (HPV), one of the key risk factors for the disease. The benefit was greater for HPV-positive patients, with median overall survival hitting 9.1 months compared to 4.4 months for the standard treatments, BMS reported.
That data was presented the day after BMS released results from another trial showing that 34% of patients taking Opdivo for melanoma, the most deadly form of skin cancer, were still alive after 5 years of treatment.
Bristol-Myers and Merck are testing their drugs against a host of cancers, as solo treatments and in tandem with other cancer drugs as they each shoot for preeminence with these new-generation drugs that harness the immune system to fight cancer.
First approved in 2014, both of the meds are forecast by EvaluatePharma to be among the top 20 best-selling drugs in the world by 2020. The pharma research firm believes Opdivo could reach $8.4 billion in annual sales by 2020 sales while it forecasts Keytruda achieving $4.5 billion in annual sales.
- here’s the release