globaldataBristol-Myers Squibb (BMS) and Merck & Co. are set to continue their strong rivalry in the head and neck cancer space, as their respective PD-1 inhibitory monoclonal antibodies, Opdivo and Keytruda, race to enter the market, according to an analyst with research and consulting firm GlobalData.

Both drugs have shown promise in clinical trials, and are therefore set to make waves across the head and neck cancer market which, as stated in GlobalData’s most recent Head and Neck Cancer report, will grow rapidly to more than $1.5 billion by 2024.

Amy Yip, PhD, GlobalData’s analyst covering oncology and haematology, says: “Recent trials evaluating Opdivo’s efficacy in recurrent or metastatic head and neck squamous cell carcinoma, found that it resulted in a 30% reduction in the risk of death, and a significant improvement compared with the only targeted agent currently approved for the disease, Eli Lilly’s Erbitux (cetuximab).”

“Keytruda, by contrast, in a single-arm Phase Ib trial, was found to produce an overall response rate of 24.8%, including a complete response in one patient. This compares favourably with the 10-15% response rate commonly reported for Erbitux monotherapy. In this way, as both Opdivo and Keytruda have shown significant superiority over current standard treatments, their success could depend on how soon they are approved by the FDA,” she added.

As the first to file, Keytruda could become the first checkpoint inhibitor to reach the market. However, a filing for Opdivo is expected to occur soon, and is likely to gain full FDA approval on the strength of BMS’ Phase III data. Opdivo’s recently awarded breakthrough therapy designation for head and neck cancers should also expedite the FDA approval process. If both agents gain a second-line approval, it will be difficult to predict which of the two will garner the larger market share, and the implications for BMS and Merck could vary widely.

Yip explains: “Even in a decidedly niche indication such as head and neck cancer, there is a potential difference of hundreds of millions of dollars in sales at stake across therapy lines between the first-to-market product and the runner-up. GlobalData believes that the pressure on both companies is only going to rise while the race between BMS and Merck comes to a close.”