Phase 2b mRNA-4157 Trial Cuts Melanoma Recurrence by 49%; Gardasil Faces Q4 Slump

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Merck and Moderna’s Phase 2b mRNA-4157 plus Keytruda trial cut high-risk melanoma recurrence or death by 49% at five years, and Merck has fully enrolled Phase 3 melanoma and NSCLC studies. The company also warned that Gardasil sales weakness in China and Japan will pressure Q4 vaccine revenues.

1. Merck Launches $30 Million Ebola Vaccine Affordability Program

Merck & Co. has committed $30 million in partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop an updated version of its Ervebo Ebola vaccine. The program aims to reduce manufacturing costs, optimize supply chains and secure technology transfers to regional producers in low- and middle-income countries. Over the next three years, Merck and CEPI will co-fund preclinical optimization, scale-up studies and regulatory filings, with the goal of lowering per-dose costs by at least 40% and expanding global stockpiles to 1.5 million doses by 2027.

2. Five-Year Follow-Up Shows 49% Reduction in Recurrence or Death for Melanoma Combination Therapy

Data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial demonstrate that patients receiving intismeran autogene (mRNA-4157) plus Merck’s Keytruda in the adjuvant setting for high-risk, surgically resected Stage III/IV melanoma saw a 49% reduction in the risk of recurrence or death versus Keytruda alone. The median follow-up of five years confirms sustained recurrence-free survival benefit, consistent safety profile and durable immune responses. Merck is collaborating with Moderna on multiple ongoing Phase 3 studies across melanoma, non-small cell lung cancer, renal cell carcinoma and bladder cancer, with full enrollment achieved in the INTerpath-001 melanoma trial.

3. Gardasil Sales Weakness in China and Japan Clouds Q4 Outlook

Merck faces mounting pressure as Gardasil vaccine sales in China and Japan have declined sharply over the past two quarters, driven by intensified price competition and slower restart of school-based immunization programs. Industry analysts estimate that quarterly Gardasil revenues could drop by up to 25% year-over-year in Q4, potentially shaving $400 million off Merck’s sales forecast. Investors will closely watch Merck’s upcoming quarterly report for guidance on pricing strategies and market restoration efforts in key Asia-Pacific markets.

Sources

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