Merck and Moderna have announced encouraging five-year data for a therapy treating patients with high-risk melanoma. 

The Phase IIb trial of intismeran autogene, an investigational mRNA-based individualised neoantigen therapy (INT), reduced the risk of high-risk melanoma recurrence or death by 49% when combined with Keytruda (pembrolizumab). 

The combination therapy also demonstrated sustained improvement in the primary endpoint of recurrence-free survival for high-risk melanoma patients. 

“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 III study in adjuvant melanoma in collaboration with Merck, and continued progress across the eight Phase II and Phase III studies in multiple tumour types and patient populations.” 

“For many patients with stage III/IV melanoma, there is a significant risk of recurrence following surgery,” added Dr Marjorie Green, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories.  

“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. 

“These five-year follow up data are 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.” 

Moderna and Merck have announced eight Phase II and Phase III clinical trials are underway across multiple tumour types including melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma.

Bruno Quinney, Content Team, DDW