Merck pushes Keytruda into perioperative NSCLC setting with FDA approval


Merck pushes Keytruda into perioperative NSCLC setting with FDA approval

Published: Oct 17, 2023

By Tristan Manalac


The FDA on Monday approved the use of Merck’s blockbuster PD-1 inhibitor Keytruda (pembrolizumab) in the perioperative setting for non-small cell lung cancer.

Under the updated label, Keytruda can now be given as neoadjuvant treatment in combination with platinum-based chemotherapy, and then continued as an adjuvant monotherapy after surgery. This covers patients with resectable tumors that measure at least four centimeters or with node positivity.

The updated label also includes Keytruda’s latest overall survival (OS) data in this indication, showing that Merck’s perioperative regimen significantly reduced the risk of death by 28% compared with placebo.

Merck last week announced that Keytruda had met its survival efficacy endpoint. The company didn’t reveal the specific effect size on survival before the approval and was supposed to do so at the upcoming 2023 Congress of the European Society for Medical Oncology.

In a statement along with Monday’s approval announcement, Marjorie Green, Merck’s senior vice president and head of late-stage oncology, global clinical development, said that Keytruda “continues to change the way non-small cell lung cancer is treated” across different stages of the disease “regardless of PD-L1 expression.”

“This approval marks a pivotal moment for the lung cancer community by providing certain patients with earlier stages of non-small cell lung cancer and healthcare providers with an important new treatment option,” Green said.

This is Keytruda’s sixth approval in non-small cell lung cancer, according to Merck’s announcement.

The FDA based its approval of the label expansion on data from the Phase III KEYNOTE-671 trial, a randomized, double-blinded and placebo-controlled study assessing the perioperative regimen of Keytruda. A total of 797 patients were enrolled regardless of PD-L1 expression.

Aside from OS, KEYNOTE-671 also evaluated event-free survival (EFS) as its second primary endpoint. In March 2023, Merck released interim data from the study showing that Keytruda met this metric. The company followed this up with an August 2023 publication in The New England Journal of Medicine, which demonstrated a nearly 60% reduction in the risk of disease progression, recurrence or death in patients treated with the Keytruda regimen.

In terms of safety, the adverse events in KEYNOTE-671 were generally similar to those that develop in patients treated with Keytruda and chemotherapy.

Merck is also anticipating a bladder cancer expansion for Keytruda. Earlier this month, the PD-1 blocker induced a statistically significant and clinically meaningful improvement in disease-free survival in patients with muscle-invasive urothelial carcinoma. Keytruda is not yet approved to treat this specific type of bladder cancer and Merck is planning to discuss these data with regulators.

Source: BioSpace