US-based Merck, Sharp & Dohme Inc. (NYSE: MRK) announced the discontinuation of two Phase III trials evaluating its programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab) in new indications, due to insufficient efficacy. The decisions to halt the trials were made following recommendations from their respective independent data monitoring committees.
The trials in question were KEYNOTE-867, which assessed Keytruda in combination with stereotactic body radiotherapy (SBRT) for stage I or II non-small cell lung cancer (NSCLC), and KEYNOTE-630, which evaluated Keytruda as an adjuvant treatment for patients with high-risk locally advanced cutaneous squamous cell carcinoma (cSCC) after surgery and radiation.
KEYNOTE-867 was terminated after an interim analysis revealed no improvement in event-free survival (EFS) or overall survival (OS), along with a higher incidence of adverse events, including deaths, compared to the SBRT and placebo group. Similarly, KEYNOTE-630 was halted as Keytruda failed to improve the primary endpoint of recurrence-free survival (RFS), with data suggesting it would likely not meet the secondary endpoint related to overall survival.- Flcube.com
