Keytruda Meets Trial Goals for Non-Small Cell Lung Cancer Treatment

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Keytruda plus chemotherapy before surgery and as single agent after improved outcomes for patients with resectable non-small cell lung cancer.

In the phase 3 KEYNOTE-671 trial evaluating Keytruda (pembrolizumab) as preoperative treatment (a regimen given before and after surgier) in patients with resectable stage 2, 3a or 3b non-small cell lung cancer has met one of its primary endpoints of event-free survival (time after treatment without cancer-related complications), according to a press release from Merck, the drug’s manufacturer.

At an interim analysis Keytruda plus chemotherapy followed by resection and then Keytruda again, demonstrated a statistically significant and clinically meaningful improvement in event-free survival, compared with a placebo.

There were also statically significant improvements in the secondary goals including pathological complete response (the lack of signs of cancer in tissue removed after surgery) and major pathological response (decreased cancer found in tissue).

Based on these results, the U.S. Food and Drug has accepted Merck’s new supplemental Biologics License Application for Keytruda for the treatment of this patient’s population in combination with chemotherapy in the preoperative setting. This application is used to request permission to introduce or deliver a biologic product intro interstate commerce.

The FDA has set a Prescription Drug User Free Act, or PDUFA, or target action date of Oct. 16, 2023.

Of note, there were no new safety signals with Keytruda observed.

This trial will continue to evaluate the other primary endpoint of overall survival (time from treatment until disease worsens) and further, detail results will be presented at an upcoming medical meeting.

“By moving this Keytruda-based regimen into earlier stages of non-small cell lung cancer, we may be able to significantly reduce the risk of recurrence for these patients. This study is an important milestone, and we look forward to sharing the detailed results with the medical community as soon as possible. We thank the patients and investigators for their important contributions to this study,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, in the release.

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