Pharma powerhouses Moderna and Merck have claimed data from their five-year study showed that mRNA therapy plus KEYTRUDA cuts melanoma recurrence risk by nearly half.
The data is from their Phase 2b KEYNOTE-942/mRNA-4157-P201 study.
The study evaluated patients with stage III/IV melanoma after complete tumor resection. The latest analysis shows the combination therapy reduced the risk of recurrence or death by 49% compared to KEYTRUDA alone; one-sided nominal.
“Now with five years of follow-up data, today’s results highlight the potential of a prolonged benefit of the intismeran autogene and KEYTRUDA combination in patients with resected high-risk melanoma,” said Kyle Holen, Moderna’s Senior Vice President and Head of Development, Oncology and Therapeutics.
“We continue to invest in our platform in oncology because of encouraging outcomes like these, which illustrate mRNA’s potential in cancer care. We look forward to several additional milestones to come, including the results of our Phase 3 study in adjuvant melanoma in collaboration with Merck, and continued progress across the eight Phase 2 and Phase 3 studies in multiple tumor types and patient populations.”
“For many patients with stage III/IV melanoma, there is a significant risk of recurrence following surgery. As such, demonstrating the longer-term potential of intismeran autogene and KEYTRUDA to reduce the risk of recurrence for certain patients with melanoma is a meaningful milestone,” said Dr Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.
“These five-year follow up data are encouraging and we look forward to late-stage data from the INTerpath clinical development program with Moderna, across a range of tumor types where significant unmet needs remain.”
The five-year analysis builds on prior evaluations at two and three years of follow-up. The safety profile of intismeran autogene combined with KEYTRUDA remains consistent with earlier reports.
Beyond melanoma, Moderna and Merck are advancing multiple trials: the Phase 3 INTerpath-001 study in adjuvant melanoma is fully enrolled, while Phase 3 studies in non-small cell lung cancer (NSCLC) and Phase 2 studies in renal cell carcinoma, bladder cancer, metastatic melanoma, and metastatic squamous NSCLC are ongoing or enrolling.
