Press release
Moderna and Merck Announce mRNA-4157 (V940) in Combination With KEYTRUDA(R) (pembrolizumab) Demonstrated a Statistically Significant and Clinically Meaningful Improvement in Distant Metastasis-Free Survival in Patients with High-Risk Stage III/IV Mela...
Moderna and Merck Announce mRNA-4157 (V940) in Combination With KEYTRUDA(R) (pembrolizumab) Demonstrated a Statistically Significant and Clinically Meaningful
About this update from Moderna, Inc.
[{"type":"text","content":"Moderna and Merck Announce mRNA-4157 (V940) in Combination With KEYTRUDA(R) (pembrolizumab) Demonstrated a Statistically Significant and Clinically Meaningful Improvement in Distant Metastasis-Free Survival in Patients with High-Risk Stage III/IV Melanoma Following Complete Resection Versus KEYTRUDA \n mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of distant metastasis or death by 65% (HR=0.347 [95% CI, 0.145-0.828]); one-sided p value=0.0063) compared to KEYTRUDA aloneThe DMFS results, a key secondary endpoint of the Phase 2b KEYNOTE-942 study, will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual MeetingCompanies plan to initiate a Phase 3 study in the adjuvant setting in patients with high-risk melanoma in 2023, and rapidly expand to additional tumor types, including non-small cell lung cancerCAMBRIDGE, MA and RAHWAY, NJ / ACCESSWIRE / June 5, 2023 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced distant metastasis-free survival (DMFS) results from the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck's anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV). In the overall intention-to-treat (ITT) population, adjuvant treatment with mRNA-4157 (V940) in combination with KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in DMFS, a key secondary endpoint of the study, compared with KEYTRUDA alone and reduced the risk of developing distant metastasis or death by 65% (HR=0.347 [95% CI, 0.145-0.828]); one-sided p value=0.0063). The secondary endpoint of DMFS, defined as the time from the first dose of KEYTRUDA until the date of first distant recurrence or death from any cause, was pre-specified for statistical testing following the positive primary endpoint of recurrence-free survival (RFS). These late-breaking data are being presented for the first time today at 5:00 p.m. ET during an oral abstract session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (abstract #LBA9503).\"We are excited to be sharing t...