Moderna and Merck (known as MSD outside the US) have announced five-year follow-up data from their study of intismeran autogene, in combination with Keytruda (pembrolizumab), in patients with high-risk melanoma following complete resection.
Follow-up results from the phase 2b KEYNOTE-942/mRNA-4157-P201 study showed that the combination treatment demonstrated sustained improvement in recurrence-free survival (RFS), which was the study’s primary endpoint. It was found to reduce the risk of recurrence or death by 49% compared with Keytruda alone.
The safety profile of the intismeran/Keytruda combination treatment at five years of follow-up was found to be consistent with its reported safety profile at two and three years.
Moderna and Merck plan to present additional study data at a future medical meeting.
Melanoma is caused by the uncontrolled growth of pigment-producing cells. Rates of the disease have been growing over the past decades, with over 330,000 new cases diagnosed globally in 2022. Skin cancer is one of the most common types of cancer diagnosed in the US, with melanoma accounting for the majority of US skin cancer deaths.
Estimates show more than 100,000 newly diagnosed melanoma cases, and more than 8,000 deaths from the disease, in the US in 2025.
A phase 3 trial of the combination treatment in adjuvant melanoma, INTerpath-001, has already completed enrolment. Enrolment has also begun in two phase 3 trials of the treatment in resectable non-small cell lung cancer (NSCLC) following neoadjuvant Keytruda and platinum-based chemotherapy. Phase 2 studies are likewise enrolling patients with resected muscle invasive and resected non-muscle invasive bladder cancer, metastatic melanoma and metastatic squamous NSCLC.
Kyle Holen, senior vice president and head of development, oncology and therapeutics at Moderna, said: “Now with five years of follow-up data, these results highlight the potential of a prolonged benefit of the intismeran autogene and Keytruda combination in patients with resected high-risk melanoma.”
Dr Marjorie Green, senior vice president and head of oncology, global clinical development at Merck Research Laboratories, added: “This five-year follow-up data is encouraging and we look forward to late-stage data from the INTerpath clinical development programme with Moderna, across a range of tumour types where significant unmet needs remain.”