Key Findings
The combination of the personalized intismeran autogene vaccine and the immunotherapy Keytruda (pembrolizumab) demonstrated a hazard ratio of 0.58, reducing the risk of recurrence or death by 42% compared to Keytruda alone at 24 months. Recurrence-free survival (RFS) at this timepoint was 82.2% for the combination group versus 70.0% for the control group. Additionally, distant metastasis-free survival (DMFS) at two years improved by 38%, reaching 88.5% in the combination group compared to 80.2% in the Keytruda-only group.
Technical Details
The intismeran autogene vaccine is developed using a personalized approach:
- Tumor sampling is used to determine the patient’s unique mutational signature.
- Up to 34 cancer neoantigens—proteins appearing on tumor cells but not healthy cells—are identified.
- These antigens are used to prime the immune system to target and attack the cancer.
Safety data from the INTerpath-001 study remained consistent with previous earlier studies, and benefits were observed consistently across different patient groups.
Background and Context
The data was released early following a leak first reported by STAT and confirmed by the ESMO secretariat, ahead of the scheduled presentation at ESMO in Madrid. Following the leak, Moderna’s shares fell nearly 18% and MSD shares dipped slightly. This market reaction is attributed to RFS and DMFS results being slightly lower than those seen in mid-stage trials, as well as a correction after stock gains in August.
Significance and Outlook
MSD’s head of R&D, Dean Li, stated that INTerpath-001 is the first phase 3 study to show a clinically meaningful improvement in RFS and DMFS over the standard-of-care Keytruda for resected melanoma. Moderna and MSD are preparing marketing applications, with potential approvals possible next year. Beyond melanoma, this technology may pave the way for Moderna’s mRNA-based vaccine pipeline currently in trials for kidney, bladder, and lung cancers.
Source: https://pharmaphorum.com/news/esmo26-moderna-msd-reveal-cancer-jab-data-early-after-leak
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