Moderna and Merck (MSD) have successfully suppressed melanoma recurrence and distant metastasis in a Phase 3 clinical trial with a personalized messenger RNA (mRNA) cancer vaccine jointly developed by the two companies. This is the first case in which an mRNA-based cancer treatment has demonstrated efficacy in late-stage clinical trials.
Moderna and Merck of the United States announced on the 19th (local time) that, in an interim analysis of the global Phase 3 trial 'INTerpath-001' conducted on patients with high-risk melanoma, the combination therapy of the cancer vaccine 'intismeran autogene' and the immunotherapy 'Keytruda' significantly improved recurrence-free survival (RFS) compared with Keytruda monotherapy. It also met the key secondary endpoint of distant metastasis-free survival (DMFS).
A total of 1,137 patients with stage 2B to 4 cutaneous melanoma whose tumors were completely removed through surgery participated in this clinical trial. Patients were assigned in a 2-to-1 ratio to either the intismeran and Keytruda combination group or the Keytruda monotherapy group. The combination group received intismeran up to 9 times every 3 weeks and Keytruda up to 9 times every 6 weeks.
Intismeran is a personalized treatment designed to target up to 34 neoantigens after analyzing a patient's tumor tissue to identify unique genetic mutations. When administered into the body, the mRNA trains the immune system on the characteristics of cancer cells, inducing T cells to recognize and attack cancer cells. Keytruda blocks the PD-1 pathway that cancer cells use to evade immune attacks.
Specific hazard ratios and detailed safety data from this Phase 3 trial have not yet been disclosed.
The two companies plan to apply for approval with the U.S. Food and Drug Administration (FDA) and aim to launch it next year.
Meanwhile, Moderna and Merck are currently conducting a total of 9 Phase 2 and 3 clinical trials expanding intismeran not only to melanoma but also to non-small cell lung cancer, bladder cancer, and kidney cancer.
