Moderna announced it will seek regulatory approval for intismeran autogene, a personalized melanoma vaccine developed with Merck, according to the company’s November 6 earnings release. The therapy could add a new revenue stream beyond the COVID-19 shots that built its business.
Investor enthusiasm has surged, pushing Moderna shares up more than 700% this year, a rally analysts link to the experimental cancer vaccine.
As demand for COVID-19 vaccines fell, the company’s annual revenue dropped roughly 90%, falling from $19.3 billion in 2022 to $1.9 billion in 2025.
The oncology partnership began in 2016, with a Phase 2b melanoma study enrolling patients in 2019. Merck exercised its option to co-develop and market the therapy in 2022, paying $250 million and agreeing to split development costs and profits equally.
Intismeran is intended to prevent melanoma recurrence after surgery. Each patient’s tumor mutations guide the selection of up to 34 neoantigens, which are encoded in a custom mRNA vaccine. The goal is to steer T-cells toward cancer cells while Keytruda blocks an immune-suppressing signal.
The Phase 3 INTerpath-001 trial enrolled 1,137 high-risk melanoma patients whose tumors had been surgically removed. Adding intismeran cut the risk of recurrence or death by 42% versus Keytruda alone, and at two years, 82.2% of combination recipients were alive without recurrence compared with 70.0% in the control arm.
A prespecified sensitivity analysis showed a 58% risk reduction after the six-month mark, following the immunization schedule. Grade 3-5 treatment-related adverse events occurred in 14.2% of combination patients versus 13.4% of controls, and the study continues to monitor overall survival.
Personalized mRNA vaccines like intismeran illustrate a shift from generic treatments toward therapies that match each patient’s tumor profile, leveraging the platform that proved its scalability during the pandemic.
Beyond melanoma, the partners are testing the approach in kidney, bladder and three lung cancer trials, with analysts pointing to upcoming readouts as key catalysts for Moderna shares. The company also expects results this year for mRNA-3927, an experimental therapy for propionic acidemia, while its norovirus vaccine program was paused after an interim analysis fell short of early-success thresholds.
