In a statement shared by Moderna and Merck (MSD) in December 2023 it was announced that follow-up data from the Phase IIb randomised KEYNOTE trial demonstrate “meaningful” improvement for patients. The trial is evaluating mRNA-4157 (V940), Moderna’s investigational individualised neoantigen therapy (INT), in combination with Merck’s anti-PD-1 therapy KEYTRUDA in patients with resected high-risk melanoma following complete resection.
The latest news is that in a planned analysis with a median follow-up of roughly three years, the treatment “continued to demonstrate a clinically meaningful improvement” in recurrence-free survival (RFS), reducing risk of recurrence or death by 49%. Furthermore, the combination “continued to demonstrate a meaningful improvement” in distant metastasis-free survival (DMFS), reducing risk of developing distant metastasis or death by 62%.
Another positive step
Dr Kyle Holen, Senior Vice President and Head of Development, Therapeutics and Oncology, commented on the team’s excitement at seeing “such a robust clinical benefit” to people with resected high-risk melanoma.
“These data add another positive analysis to the multiple endpoints and subgroups previously assessed in this study.”
Dr Holen adds that this is the “first demonstration of efficacy for an investigational mRNA cancer treatment in a randomised clinical trial” as well as the “first combination therapy to show a significant benefit over KEYTRUDA alone in adjuvant melanoma”.
“We look forward to sharing these data with people impacted by this disease and the broader scientific community.”
Merck’s senior vice president and head of late-stage oncology, global clinical development is Dr Marjorie Green, who is “committed to driving research forward for innovative modalities in earlier stages of cancer”, which is where the “most meaningful” effects can be seen for patients.
“We are pleased to see the results from this planned analysis on recurrence-free survival for V940 (mRNA-4157) and look forward to working with Moderna in expanding our clinical development programme.”
We just heard of the initiation of a Phase III trial in non-small cell lung cancer, so what is next for this dynamic collaboration? For more from Dr Holen, check out his interview here or join us at the Washington Congress 2024. If you can’t make it, why not subscribe for more insights?
