MSD’s Keytruda improved overall survival by up to 39% in first-line head and neck cancer, new results show.

Interim data from KEYNOTE-048 showed Keytruda monotherapy improved overall survival (OS) by 39% in patients whose tumors expressed PD-L1 with Combined Positive Score (CPS) greater-than or equal to 20, and by 22% in patients with CPS greater than or equal to 1, compared to the current standard of care.

In addition, Keytruda in combination with chemotherapy demonstrated improved OS by 23 percent regardless of PD-L1 expression.

“In this study, KEYTRUDA showed the potential to significantly prolong survival when used as first-line therapy for patients whose head and neck cancer had recurred or spread,” said Dr. Barbara Burtness, lead investigator for KEYNOTE-048, professor of medicine at Yale School of Medicine and co-director, Development Therapeutics Research Program, Yale Cancer Center. ”This is a devastating cancer when it recurs, and there has not been any advance in first-line treatment for over a decade. It is thrilling to see these new data, which have the potential to alter the standard of care in the first-line treatment of head and neck cancer.”

In more good news for Keytruda, the drug was approved by the EMA as adjuvant therapy in the treatment of patients with melanoma with lymph node involvement who have undergone complete surgical resection. This recommendation is based on data that demonstrated a significant improvement in recurrence-free survival (RFS) for the drug in the pivotal Phase 3 EORTC1325/KEYNOTE-054 trial, which was conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC).