Keytruda: Mixed Results in Gastric Cancer Study
Even a drug as vaunted as Merck & Company’s Keytruda is bound to miss the mark once in a while. The company reported Thursday that the checkpoint inhibitor, which has been approved for multiple indications, had mixed results as a first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
In the Phase III KEYNOTE-062 trial, Merck said Keytruda, an anti-PD-1 therapy, hit the mark as a monotherapy by demonstrating non-inferiority to chemotherapy for overall survival (OS) in the entire intention-to-treat (ITT) population of patients whose tumors expressed PD-L1. Chemo is the current standard of care for these patients. However, in combination with chemotherapy, Keytruda failed to demonstrate superiority for overall survival or progression-free survival, the company said.
Keytruda’s safety profile remained consistent, Merck said. The KEYNOTE-062 trial was examining Keytruda as monotherapy and in combination with chemotherapy as a first-line treatment in patients with advanced gastric or GEJ adenocarcinoma whose tumors express PD-L1 and who are human epidermal growth factor receptor 2 (HER2) negative. The trial also looked at progression-free survival in patients whose tumors express PD-L1 for the combination arm. Key secondary endpoints included overall response rate and duration of response in patients whose tumors express PD-L1. Full details of the Phase III trial will be presented during an oral session of the American Society of Clinical Oncology meeting in Chicago this summer.
Gastric cancer, or stomach cancer, tends to develop slowly over many years. Most gastric cancers are adenocarcinomas, which develop from the cells of the innermost lining of the stomach. Gastric cancer is the fifth most frequently diagnosed cancer worldwide, with approximately 1,033,700 new cases and 782,700 deaths from the disease estimated in 2018. In the U.S., an estimated 27,500 cases of gastric cancer will be diagnosed in 2019, with 11,100 deaths expected to occur, Merck said. In 2017 Keytruda was approved by the U.S. Food and Drug Administration as a third-line treatment for previously treated patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction cancer whose tumors express PD-L1.
Roy Baynes, head of global clinical development and chief medical officer at Merck Research Laboratories, noted that gastric cancer is a difficult disease to treat and is associated with high mortality rates across the globe, particularly those cases in the metastatic stage.
“Keytruda monotherapy did show non-inferior overall survival in the total patient population, though the study did not meet all of its primary endpoints. We sincerely thank the patients and investigators for their involvement in KEYNOTE-062 and look forward to sharing detailed study results with the medical community,” Baynes said in a statement.
The mixed results for gastric cancer came only days after the FDA approved Keytruda for another indication. On Monday, Keytruda in combination with chemotherapy was given the regulatory go-ahead under priority review as a first-line treatment for advanced renal cell carcinoma. Earlier this month, Keytruda snagged approval a monotherapy for the first-line treatment of stage III non-small cell lung cancer in certain patients. Merck indicates that Keytruda is currently in more than 900 clinical trials in a broad range of cancers and treatment settings. Keytruda is expected to raise more than $10 billion in sales this year. That will be a significant jump over 2017, when Keytruda brought in $3.7 billion.
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