Trial Discontinuation: External DMC recommends discontinuing Ph 3 KEYNOTE-D46/EVOKE-03 study of Trodelvy + KEYTRUDA in 1L metastatic NSCLC with high PD-L1 expression
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Gilead Sciences, Inc. (Nasdaq: GILD) today announced the discontinuation of the Phase 3 KEYNOTE-D46/EVOKE-03 study investigating Gilead’s Trodelvy® (sacituzumab govitecan-hziy) in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, compared to KEYTRUDA monotherapy in certain patients with previously untreated metastatic non-small cell lung cancer, whose tumors expressed PD-L1 (tumor proportion score [TPS] ≥50%). The decision is based on the recommendation from the external Data Monitoring Committee (eDMC) following their review of the data from the pre-specified final analysis of progression-free survival (PFS) and interim analysis of overall survival (OS). A numerical improvement in PFS was observed, but did not reach statistical significance. The probability of achieving statistically significant OS is unlikely at the planned final analysis. The safety profile of Trodelvy in combination with KEYTRUDA was consistent with the known safety of each agent. No new safety signals were identified with the combination. These data will be presented at a future medical meeting.
Share:
More News
“These data underscore gotistobart’s potential to redefine treatment for patients with hard-to-treat squamous NSCLC whose disease has progressed after initial therapy and who face limited options,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “In second- and later lines of treatment, the clinical relevance of novel
“The collaboration with Ratio represents an exciting opportunity to explore the potential of novel radiopharmaceutical approaches designed to address the complexity and heterogeneity of cancer,” said Ben Hickey, President of RayzeBio. “The combination of our respective technologies and complementary development expertise creates a strong foundation for generating a novel differentiated
“We believe these results mark a potentially important step forward in the treatment of EGFR exon 20 insertion mutation-positive non-small cell lung cancer,” said Fabio Benedetti, MD, Global Chief Medical Officer, Taiho Pharmaceutical. “To address the unmet medical needs of patients and their families, we will continue working closely with
“Recent clinical data validated KAT6 as a targetable mechanism in the treatment of HR+/HER2- breast cancer, including those with actionable mutations,” stated Charles Morris, MBChB, MRCP, Chief Medical Officer of Prelude. “Dual KAT6A/B inhibitors, however, demonstrated overlapping toxicities with current backbone therapies that may limit the utility in earlier lines