Keytruda combination hits primary endpoint in a rare form of gastric cancer

Merck’s Keytruda notched another positive set of data, this time in a rare cancer of the esophagus that sets up the company to receive full approval in this indication.

The drugmaker announced Friday that a Phase III trial investigating Keytruda in combination with Herceptin and chemo met one of two primary endpoints for progression-free survival as a first-line of treatment for gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The combination therapy demonstrated statistically significant improvements in PFS in patients whose tumors were PD-L1 positive compared to placebo.

Scot Ebbinghaus

Scot Ebbinghaus, VP for global clinical development at Merck Research Laboratories, described the data as “meaningful,” saying they “build on the earlier insights from this study that supported the accelerated approval of this Keytruda combination in the US” for this indication.

Keytruda already received accelerated approval for gastric or GEJ in 2021. Merck said it shared the results with the FDA and is working with the agency to update the current indication for Keytruda in HER2-positive gastric or GEJ adenocarcinoma with PD-L1-positive tumors.

The study, KEYNOTE-811, showed some improvement in overall survival, the study’s other primary endpoint, but the data were not statistically significant, according to Merck’s release. The company said it plans to look at the overall survival metric in a “subsequent analysis.”

Keytruda, which brought in $20.9 billion in sales last year, has steadily gained new indications, most recently getting FDA approval as an adjuvant treatment for non-small cell lung cancer and as a combination with Seagen’s Padcev in first-line bladder cancer.

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