Merck’s Keytruda Combo Shows 49% Five-Year Melanoma Recurrence Risk Reduction
Moderna and Merck’s Phase 2b KEYNOTE-942 study showed that adjuvant intismeran autogene combined with Merck’s Keytruda cut five-year high-risk melanoma recurrence or death risk by 49% versus Keytruda alone. Merck plans to present further follow-up data and has fully enrolled its Phase 3 adjuvant melanoma INTerpath-001 trial.
1. Merck and CEPI Launch $30 Million Ebola Vaccine Access Program
Merck & Co. has joined forces with the Coalition for Epidemic Preparedness Innovations (CEPI) to invest $30 million in the development of an updated formulation of its licensed Ebola vaccine. The initiative aims to reduce production costs and simplify the cold-chain requirements, targeting annual manufacturing capacity of at least 5 million doses for distribution in low- and middle-income countries. Under the agreement, Merck will leverage its existing production infrastructure in Europe, while CEPI will support formulation optimization and early regulatory interactions. The partners expect to complete preclinical studies by mid-2025 and to submit data for World Health Organization prequalification in late 2026, potentially enabling broader rollout in outbreak regions across sub-Saharan Africa.
2. Five-Year Data Highlight 49% Reduction in Melanoma Recurrence Risk
In a long-term follow-up of the Phase 2b KEYNOTE-942/mRNA-4157 study, Moderna and Merck reported that their individualized neoantigen vaccine, intismeran autogene (mRNA-4157/V940), combined with Merck’s checkpoint inhibitor Keytruda, achieved a 49% reduction in the risk of recurrence or death versus Keytruda alone in patients with high-risk (stage III/IV) melanoma following surgical resection. With a median follow-up of five years, the combination therapy maintained a favorable safety profile consistent with earlier analyses. The fully enrolled Phase 3 INTerpath-001 trial in the adjuvant melanoma setting is under way, and multiple Phase 3 studies in non-small cell lung cancer are enrolling, alongside Phase 2 trials in renal cell carcinoma, bladder cancer and metastatic melanoma. Further data on secondary endpoints and immune correlates will be presented at an upcoming oncology conference.
3. Gardasil Sales Decline in Key Asian Markets Clouds Q4 Outlook
Merck faces mounting pressure on its fourth-quarter revenue forecast as sales of its human papillomavirus vaccine, Gardasil, have declined sharply in China and Japan. Industry estimates suggest year-over-year revenue in those two markets fell by more than 20% in the most recent quarter, driven by intensified local competition and pricing pressure following recent reimbursement reforms. Investors will be watching for Merck’s commentary on inventory adjustments and expected volume growth in emerging markets when the company reports earnings next month.