Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that a late-stage trial for its anti-PD-1 drug Keytruda (pembrolizumab) has successfully met the primary endpoint of statistically significant and clinically meaningful improvement in overall survival (OS) in patients with resectable non-small cell lung cancer (NSCLC). The trial evaluated Keytruda as part of a perioperative regimen, and the results were compared to those of a placebo group.
Significance of the Trial Results
Earlier this year, MSD announced that the trial had already met the other dual primary endpoint of event-free survival (EFS), among other interim results. The interim data has been accepted for review by the US Food and Drug Administration (FDA), MSD’s homeland regulator, with a decision anticipated this month. This regulatory review is a critical step towards potential label expansion for Keytruda in the treatment of NSCLC.
Global Submission Plans
Following the positive trial outcomes, MSD now plans to submit the full results to health authorities worldwide. This move is expected to bolster Keytruda’s position as a leading therapy in various NSCLC indications and could lead to broader access for patients globally.
Keytruda’s Ongoing Development
Keytruda has completed development in several NSCLC indications, including advanced disease, and is currently involved in a number of studies focused on earlier stages of the disease. The continued research and development efforts underscore MSD’s commitment to expanding treatment options for patients with NSCLC and improving outcomes in the fight against this form of cancer.
Conclusion
The successful late-stage trial results for Keytruda in resectable NSCLC mark a significant milestone for MSD and provide hope for patients with this disease. With global submissions on the horizon, Keytruda’s impact on NSCLC treatment is set to expand, potentially changing the standard of care for patients around the world.-Fineline Info & Tech
