FDA approves Merck’s Keytruda for patients with recurrent or metastatic HNSCC

New treatment option for patients with with disease progression on or after platinum-containing chemotherapy.

The approval is based on data from the KEYNOTE-012 study, which included patients with recurrent or metastatic HNSCC who had disease progression on or after platinum-containing chemotherapy or following platinum-containing chemotherapy administered as part of induction, concurrent, or adjuvant therapy and ECOG performance status (PS) of zero or one. The data showed an objective response rate (ORR) of 16%, complete response rate of 5%, with responses of 6 months or longer observed in 82% of the responding patients. ORR and duration of response were similar regardless of human papilloma virus (HPV) status.

“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. “Together with prior approvals in the treatment of other tumour types, today’s action by the FDA underscores our tireless commitment to addressing the unmet needs of patients suffering from a broad range of cancers.”

KEYNOTE-012 was the first clinical study to investigate the role of a PD-1 inhibitor in patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. Merck currently has the largest immuno-oncology clinical development program, including multiple registration-enabling studies in head and neck cancer, and is conducting research investigating Keytruda (pembrolizumab) as a monotherapy, as well as in combination with chemotherapy compared to the current standard of care.

“Head and neck cancer is a complex disease that historically has been associated with high recurrence rates and poor long-term outcomes, highlighting the critical need for new treatment options,” said Dr Tanguy Seiwert, associate director of the Head and Neck Cancer Program and assistant professor of medicine at The University of Chicago. “The approval of Keytruda for previously treated patients with recurrent or metastatic HNSCC is an important step forward in treating this disease.”

Keytruda is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumour cells. Keytruda blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells.

“HNSCC presents unique challenges including limited treatment options, especially for patients with recurrent or metastatic disease,” said Holly Boykin, executive director, Head and Neck Cancer Alliance. “We welcome the approval of Keytruda as a new treatment option for people whose lives are affected by this devastating disease.”