Personalized mRNA Cancer Treatment Successfully Completes Phase 3 Trial

For the first time, a personalized mRNA cancer treatment developed using AI has successfully completed a Phase 3 trial.

Moderna and Merck sequence each patient's tumor and compare it to healthy DNA. AI then helps identify which tumor mutations are most likely to elicit an immune response.

Based on these targets, Moderna creates a personalized mRNA treatment encoding up to 34 neoantigens to train the immune system to recognize and attack cancer cells.

"Earlier results from Phase 2b were already impressive: five years later, 68.8% of patients remained cancer-free compared to 49.1% with KEYTRUDA alone. The combination reduced the risk of recurrence or death by 49%, and the risk of distant metastasis or death by 59%."

Now, a much larger Phase 3 trial, INTerpath-001, has successfully concluded with 1,137 patients participating.

"Intismeran autogene (V940) from Merck and Moderna in combination with KEYTRUDA (pembrolizumab) significantly improved recurrence-free survival and distant metastasis-free survival compared to KEYTRUDA alone in patients with completely resected melanoma stages IIB–IV."

The Phase 3 trial achieved both the primary endpoint of recurrence-free survival and the key secondary endpoint of distant metastasis-free survival.