FDA Grants Priority Review to Merck’s sBLA for Keytruda Plus Chemotherapy as First-Line Treatment for Esophageal and GEJ Cancer

MSD Announces FDA Acceptance of Supplemental Biologics License Application (sBLA) for Keytruda in Combination with Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic Esophageal and Gastroesophageal Junction (GEJ) Cancer; Priority Review GrantedMerck Sharp & Dohme (MSD) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for its blockbuster PD-1 inhibitor Keytruda, in combination with chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic esophageal cancer and gastroesophageal junction (GEJ) cancer. The FDA has also granted priority review designation to this application. A decision is expected by April 13 next year.

Esophageal cancer is a difficult-to-treat malignancy that originates in the inner lining (mucosa) of the esophagus and grows outward. The two main types of esophageal cancer are squamous cell carcinoma and adenocarcinoma. Esophageal cancer is the seventh most common cancer and the sixth leading cause of cancer-related death worldwide. In 2018, it was estimated that there were over 572,000 new cases of esophageal cancer diagnosed globally, with nearly 509,000 deaths attributed to the disease. In China, it is the fourth leading cause of cancer-related death, following lung cancer, gastric cancer, and liver cancer. The high incidence of esophageal cancer in China may be associated with the dietary habit of consuming food and beverages at high temperatures (“eating while hot”).

This sBLA is based on the positive results from the pivotal Phase 3 KEYNOTE-590 clinical trial. In this trial, the combination therapy of Keytruda and chemotherapy significantly improved overall survival (OS) and progression-free survival (PFS) compared with chemotherapy alone, regardless of PD-L1 expression status or tumor histology.

Interim analysis data presented at this year’s ESMO Congress showed that, with a median follow-up of 10.8 months, Keytruda combination therapy reduced the risk of death by 27% compared with chemotherapy (HR=0.73; 95% CI, 0.62–0.86; p<0.0001). The median overall survival (OS) was 12.4 months in the Keytruda group versus 9.8 months in the chemotherapy group.

▲Survival Data for Keytruda Combination Therapy in the KEYNOTE-590 Clinical Trial (Image source: MSD official website)

Notably, in the Asian patient subgroup, this combination therapy demonstrated superior efficacy compared with the overall patient population, reducing the risk of death by 36% (HR=0.64) and the risk of disease progression or death by 41% (HR=0.59).

References:

[1] FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic Esophageal and Gastroesophageal Junction Cancer. Retrieved December 17, 2020, from https://www.businesswire.com/news/home/20201217005083/en/FDA-Grants-Priority-Review-to-Merck%E2%80%99s-Supplemental-Biologics-License-Application-for-KEYTRUDA%C2%AE-pembrolizumab-Plus-Chemotherapy-as-First-Line-Treatment-for-Locally-Advanced-Unresectable-or-Metastatic-Esophageal-and-Gastroesophageal-Junction-Cancer

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