The US Food and Drug Administration (FDA) has accepted Merck & Co (MSD)’s new supplemental biologics licence application (sBLA) of its anti-PD-1 therapy Keytruda in combination with chemotherapy, as a first-line treatment for gastric cancer, for review.
Through this sBLA, the company is seeking approval for the combination therapy for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Keytruda is an anti-programmed death receptor-1 (PD-1) therapy, which helps enhance the capability of the body’s immune system to identify and kill tumour cells.
It is a humanised monoclonal antibody, which blocks the interaction between PD-1 and its PD- L1 and PD-L2 ligands to activate T lymphocytes that are expected to affect both tumour and healthy cells.
MSD Research Laboratories global clinical development vice-president Dr Scot Ebbinghaus said: “The five-year survival rate for patients diagnosed with metastatic gastric cancer is estimated to be only 6%, and 80% of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma have HER2-negative disease.
“We are committed to working closely with the FDA to bring KEYTRUDA to more patients with gastric and gastroesophageal junction cancer who are in need of additional treatment options that may help them live longer.”
The company’s application is based on data from the KEYNOTE-859 study, which showed Keytruda plus chemotherapy’s statistically significant improvement in overall survival (OS) against chemotherapy alone in patients who were human epidermal growth factor receptor 2 (HER2) negative.
KEYNOTE-859 is a randomised and double-blind Phase III trial designed to assess Keytruda and chemotherapy against placebo in combination with chemotherapy for the first-line treatment of HER2-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma patients.
OS is the primary endpoint of the trial with 1,579 patients, while progression-free survival, ORR, duration of response and safety are the secondary endpoints.