Moderna and Merck report positive topline results from the Phase 3 INTerpath-001 trial for intismeran autogene, a personalized mRNA neoantigen therapy combined with Keytruda for resected stage IIB-IV melanoma.International Business TimesLab + Life ScientistOncodailyCure Today
The combination significantly improved recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) compared to Keytruda alone in 1,137 patients, marking the first successful Phase 3 readout for this therapeutic class.Cure TodayFox NewsEuropean Pharmaceutical ReviewWDRB
Moderna and Merck announced that intismeran autogene plus Keytruda met its primary endpoints of improving RFS and DMFS in a Phase 3 study of 1,137 high-risk melanoma patients. The personalized vaccine is designed to teach the immune system to target tumor-specific mutations, offering a mechanism distinct from chemotherapy or broad immunostimulation.
The INTerpath-001 trial evaluated adjuvant intismeran autogene, an mRNA-based neoantigen therapy tailored to each patient's unique mutational signature, alongside pembrolizumab. Each dose contains synthetic mRNA coding for up to 34 neoantigens derived from the patient's tumor, aiming to activate a targeted anti-tumor immune response in patients with completely resected stage IIB–IV melanoma.
Merck CEO Rob Davis highlighted the positive Phase 3 topline results for intismeran autogene plus Keytruda in the adjuvant setting for resected stage IIB-IV melanoma. He described the achievement as a defining moment for cancer research, validating the joint effort between Merck and Moderna scientists in developing this individualized neoantigen therapy.
Professor Marco Donia noted that while the Phase 3 INTerpath-001 trial showed positive results for intismeran autogene plus pembrolizumab in 1,137 patients, full efficacy data including hazard ratios and overall survival are not yet disclosed. He emphasized the importance of awaiting peer-reviewed data before fully assessing the absolute benefit.
Moderna President Stephen Hoge stated that if regulators approve the personalized cancer vaccine, thousands of patients with high-risk resected melanoma could benefit as soon as next year. The announcement comes as Moderna and Merck seek to establish this mRNA-based neoantigen therapy as a standard adjuvant treatment.
Following the announcement of successful Phase 3 trial results for the personalized cancer vaccine, Moderna's stock surged over 140% in a single week. Merck's shares also rose approximately 11%, reflecting investor optimism about the commercial potential and regulatory pathway for the intismeran autogene program.
The combination of the personalized vaccine and Keytruda has been reported to outperform Keytruda alone in preventing melanoma recurrence. This marks the first positive Phase 3 trial for a personalized cancer vaccine, signaling a potential shift in adjuvant treatment standards for high-risk patients following surgical resection.
Merck and Moderna announced that their personalized mRNA vaccine regimen successfully passed a large Phase 3 trial, reducing the risk of melanoma return or spread. While the FDA has not yet approved the treatment, the companies note it is the first combination regimen to demonstrate success in potentially extending lifespans for high-risk resected melanoma patients.
In the INTerpath-001 trial, 1,137 patients with resected stage IIB through IV melanoma were randomized to receive Keytruda plus the personalized vaccine or Keytruda plus placebo. The combination arm showed significantly better recurrence-free and distant metastasis-free survival, marking the first positive Phase 3 result for an mRNA-based personalized cancer therapy.
MSD and Moderna reported the first positive Phase III readout for an individualized neoantigen therapy (INT) combined with an mRNA-based cancer therapy. The data shows intismeran autogene plus pembrolizumab can facilitate longer cancer-free survival in completely resected stage IIB-IV melanoma compared to Keytruda alone.
Moderna and Merck announced that their experimental personalized vaccine, combined with Keytruda, kept melanoma from spreading or returning longer than Keytruda alone in a trial of 1,137 patients. Experts describe the approach as highly promising for delaying recurrence and extending survival, with implications potentially reaching beyond melanoma to other cancer types.
A personalized vaccine paired with Keytruda has shown strong results in reducing melanoma recurrence and spread compared to Keytruda alone in a late-stage trial. The announcement highlights the potential of this combination regimen to improve outcomes for patients with high-risk disease following surgical resection.
ABC News reports on the positive trial results for a personalized cancer vaccine in melanoma. The coverage underscores the significance of the Moderna and Merck partnership in delivering a treatment that targets specific tumor mutations to prevent disease recurrence.
Moderna and Merck announced positive late-stage trial results for a personalized mRNA therapy combined with Keytruda in melanoma patients who had their cancer surgically removed. The companies plan to share full data at upcoming medical meetings, noting that the treatment aims to increase the possibility of cure by intervening early in the disease course.