A personalized mRNA Vaccine cancer vaccine co-developed by Moderna and Merck (MSD) met its primary endpoint in a phase 3 melanoma trial. Compared with giving the immunotherapy Keytruda alone to patients who had their cancer removed by surgery, combining it with the mRNA Vaccine delayed cancer recurrence and metastasis to other organs.
Moderna and MSD on the 19th (local time) announced an interim analysis of the phase 3 trial "INTerpath-001," which evaluated the combination of the personalized mRNA cancer vaccine "Intismeran autogene (V940, mRNA-4157)" and Keytruda.
The trial enrolled 1,137 patients with high-risk melanoma who had their tumors removed by surgery. Participants were assigned in a 2-to-1 ratio to receive Keytruda plus the personalized mRNA Vaccine for up to about one year or Keytruda alone.
On the primary endpoint of recurrence-free survival (RFS), the combination outperformed Keytruda monotherapy. The time until cancer returned or the patient died was significantly longer.
It also met the secondary endpoint of distant metastasis–free survival (DMFS). The time until melanoma spread to other organs such as the lungs or liver, or the patient died, was also longer than with Keytruda alone.
Safety was consistent with previous clinical results.
The results are significant for the mRNA cancer vaccine field. It is the first case of an mRNA-based cancer vaccine delivering positive results in a late-stage trial, and the first late-stage clinical result to show a meaningful improvement over monotherapy by adding another therapy to Keytruda in patients with surgically removed melanoma.
However, the companies did not disclose detailed data such as the specific hazard ratio (HR) or recurrence risk reduction in this interim analysis. They plan to present detailed results at future academic meetings.
Its personalized nature also sets it apart from existing vaccines. By analyzing a patient's tumor to identify specific mutations found only in cancer cells, an mRNA Vaccine targeting those mutations is manufactured for each patient. Unlike personalized cell therapies such as CAR-T, which culture a patient's own cells for reinfusion, this approach manufactures a patient-specific vaccine.
Moderna said this approach could be relatively advantageous for scaling up manufacturing during commercialization.
Moderna and MSD plan to begin discussions with regulators soon to seek approval. Dean Li, MSD's head of research and development, told CNBC they expect to begin consultations with the U.S. Food and Drug Administration (FDA) in the coming months.
The market reacted immediately. Moderna shares surged more than 90% in premarket trading after the announcement, and MSD shares rose more than 7%.
Both companies need a commercial success from this candidate. Moderna must secure a new growth engine after its COVID-19 vaccine, and MSD needs follow-up growth drivers as the patent expiration of the blockbuster drug Keytruda approaches.
The market expects Intismeran to generate substantial revenue from the melanoma indication alone. Global investment bank Barclays projected last month that Intismeran could bring in about $3 billion (about 4.17 trillion won) in melanoma treatment revenue in 2035.
The key question ahead is whether the same effect can be replicated in cancers beyond melanoma. Moderna and MSD are expanding clinical applications to bladder and kidney cancers.