- The Food and Drug Administration has approved Merck & Co.'s Keytruda for second- and third-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This is Keytruda's third approval.
- The FDA gave Merck a contingent HNSCC approval for Keytruda under the FDA's accelerated review program, meaning that additional data will be required to convert the approval to a full approval. Approval is based on tumor response rate and durability of response in the KEYNOTE-012 study.
- Bristol-Myers Squibb, which markets the top-selling checkpoint inhibitor Opdivo, is also pursuing the head and neck cancer indication. With the latest approval for Keytruda, there is the sense that Merck is catching up with Bristol-Myers in race to rack up approvals for their respective PD-1/PD-L1 inhibitors.
The approval of Keytruda (pembrolizumab) in head and neck cancer is based on data showing an objective response rate of 16% and a complete response rate of 5%, with 82% of patients responding for at least six months. The randomized study compared treatment with Keytruda to patients who had been treated with single-agent chemotherapy.
“Today’s approval represents a meaningful advance for the oncology community, as well as for our head and neck cancer clinical program,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories.
This is the third approval for Keytruda—the foundation of Merck's oncology program. The drug has been competing closely with Bristol-Myers Squibb's checkpoint inhibitor Opdivo (nivolumab).
While showing largely comprarable efficacy in most settings, Opdivo has been the market leader so far. Yet, last week, the drug failed to meet its primary endpoint in a key trial of first-line non-small cell lung cancer (NSCLC) patients, opening the door for Keytruda to gain market share.
Despite the failure of Opdivo in that trial, Merck will have to work to gain ground and Bristol-Myers is not slowing down with its clinical plans.
Bristol-Myers is also pursuing an approval in head and neck cancer, with results from the Checkmate-141 study suggesting that an approval may be forthcoming. The trial was stopped early in January when it met its primary endpoint (increasing overall survival). The study results showed treatment with Opdivo reduced patient risk of death by 30%; improved median overall survival to 7.5 months versus other drugs' 5.1 months; and more than doubled one-year survival rates to 36%, compared with the control group's 17%.
“Head and neck squamous cell carcinoma presents unique challenges including limited treatment options, especially for patients with recurrent or metastatic disease. We welcome the approval of Keytruda as a new treatment option for people whose lives are impacted by this devastating disease," said Holly Boykin, executive director, Head and Neck Cancer Alliance.
Head and neck squamous cell carcinoma has a very low five-year survival rate in stage 4 patients, with less than 5% of patients surviving to that point. The standard of care until now has been single-agent chemotherapy and palliative care.