Clinical Report: Intismeran may improve melanoma end points

Overview

Intismeran autogene combined with pembrolizumab significantly improved recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) in patients with completely resected stage IIB to IV cutaneous melanoma compared to pembrolizumab alone, according to the phase 3 INTerpath-001 trial.

Background

The management of high-risk resected melanoma remains a critical area in oncology, as recurrence rates can be significant. Current guidelines recommend PD-1 blockade as adjuvant therapy for patients at high risk of recurrence.

Data Highlights

No new safety signals emerged in the INTerpath-001 trial, and safety findings were consistent with previous studies of intismeran and pembrolizumab.

Key Findings

• Intismeran plus pembrolizumab improved RFS and DMFS compared to pembrolizumab alone.
• The trial enrolled 1,137 patients with completely resected stage IIB to IV melanoma.
• Intismeran was administered at 1 mg every 3 weeks for up to nine doses.
• Pembrolizumab was administered at 400 mg every 6 weeks for up to 9 cycles.
• No new safety signals were reported during the trial.
• Follow-up is ongoing for other secondary outcomes, including overall survival.

Clinical Implications

Ongoing follow-up will provide further insights into overall survival and other secondary outcomes.

Conclusion

The findings from the INTerpath-001 trial indicate that the combination of intismeran and pembrolizumab improved RFS and DMFS in high-risk melanoma patients.

Related Resources & Content

1. Moderna, Press Release, 2023 -- Intismeran may improve melanoma end points
2. Moderna, Press Release, 2023 -- Vaccine Plus Pembrolizumab Reduces Risk of Recurrence in High-Risk, Resected Melanoma
3. The ASCO Post, 2016 -- Adjuvant Ipilimumab Improves Survival in High-Risk Melanoma
4. Journal of Clinical Oncology, 2023 -- Systemic Therapy for Melanoma: ASCO Guideline Update
5. PubMed, 2021 -- Adjuvant pembrolizumab versus placebo in resected stage III melanoma
6. Journal of Clinical Oncology, 2026 -- Intismeran Autogene Plus Pembrolizumab Versus Pembrolizumab Alone in High-Risk Resected Melanoma
7. the asco post — More on Melanoma From ASCO 2023: Focus on Two Different Treatment Strategies
8. Systemic Therapy for Melanoma: ASCO Guideline Update | Journal of Clinical Oncology
9. Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): distant metastasis-free survival results from a double-blind, randomised, controlled, phase 3 trial - PubMed
10. Intismeran Autogene Plus Pembrolizumab Versus Pembrolizumab Alone in High-Risk Resected Melanoma: 5-Year Update of the Randomized Phase IIb KEYNOTE-942 Study | Journal of Clinical Oncology