FDA Approves Treatment of Certain Patients With Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction Carcinoma
New Jersey-based Merck announced that the U.S. Food and Drug Administration (FDA) had approved KEYTRUDA, an anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy.
KEYTRUDA works by increasing the body’s immune system's ability to help detect and fight tumor cells, says Merck.
The approval is based on results from the Phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) for KEYTRUDA plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status.
For OS and PFS, KEYTRUDA plus FU and cisplatin reduced the risk of death by 27% and reduced disease progression or death by 35% versus FU and cisplatin alone.
The ORR, an additional efficacy outcome measure, was 45% for patients who received KEYTRUDA plus FU and cisplatin and 29% for those who received FU and cisplatin alone.
Dr. Peter Enzinger, Director, Center for Esophageal and Gastric Cancer, Dana-Farber/Brigham and Women’s Cancer Center, stated in a press release, “Today’s approval of this indication for KEYTRUDA introduces a new option, which has shown a superior survival benefit compared to FU and cisplatin alone, for newly diagnosed patients with locally advanced or metastatic esophageal or GEJ carcinoma that is not amenable to surgical resection or definitive chemoradiation, regardless of PD-L1 expression status and tumor histology.”
Esophageal cancer begins in the inner layer (mucosa) of the esophagus and grows outward. Esophageal cancer is the eighth most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide. In the U.S., about 67% of newly diagnosed esophageal cancer cases were adenocarcinoma, and 33% were squamous cell carcinoma. It is estimated there will be approximately 19,260 new cases of esophageal cancer diagnosed and about 15,530 deaths resulting from the disease in the U.S. in 2021.
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