The company has reported interim data from the pivotal phase 3 trial assessing Keytruda as both monotherapy and in combination with chemotherapy for the first-line treatment of recurrent or metastatic HNSCC.
Interim data has demonstrated that Keytruda monotherapy improved OS, which is a primary endpoint of the study, by 39% in patients whose tumors expressed PD-L1 with combined positive score.
Keytruda, in combination with chemotherapy (carboplatin or cisplatin plus 5-FU) showed improved OS compared to the Extreme regimen by 23% regardless of PD-L1 expression.
Merck Research Laboratories chief medical officer, global clinical development head and senior vice president Dr Roy Baynes said: “Keytruda is the first anti-PD-1 therapy to show superior overall survival as first-line treatment compared to the EXTREME regimen, the current standard of care in patients with recurrent or metastatic head and neck cancer.
“Recurrent or metastatic head and neck cancer is a very challenging disease. Merck would like to thank the patients and investigators for participating in this important study, which is helping to advance our understanding of the potential for KEYTRUDA and PD-1 inhibition in the first-line setting.”
Currently, Keytruda secured approval in 61 countries to treat second-line recurrent or metastatic HNSCC.
The company intends to submit a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) for a first-line indication, based on Keynote-048 data.
Keynote-048 is a randomized and open-label phase 3 trial designed to assess Keytruda monotherapy or Keytruda combination, as first-line treatment in 882 patients with recurrent or metastatic HSNCC.
KEYTRUDA is an anti-PD-1 therapy, which works by increasing the ability of the body’s immune system to help detect and fight tumor cells.
It is a humanized monoclonal antibody, which blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, enabling to activate T lymphocytes that may affect both tumor cells and healthy cells.
Separately, Merck also secured positive opinion from the the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Keytruda as adjuvant therapy in the treatment of patients with melanoma with lymph node involvement who have undergone complete surgical resection.