Merck (NYSE:MRK) and Moderna (NASDAQ:MRNA) presented detailed mid-stage results for a combination therapy containing vaccine maker’s personalized cancer shot mRNA-4157 (V940) and pharma giant’s blockbuster cancer therapy Keytruda at a medical event on Sunday.
The companies said that the novel therapeutic regimen cut the risk of recurrence or death by 44%, leading to a statistically significant and clinically meaningful improvement in recurrence-free survival (RFS) compared to Keytruda alone in patients with skin cancer, melanoma.
The Phase 2b KEYNOTE-942 (mRNA-4157-P201) trial involved patients with resected melanoma (stage III/IV) with high risk of recurrence, out of whom 107 received mRNA-4157 plus Keytruda and 50 patients underwent only Keytruda therapy.
22.4% and 40% of patients were shown to have disease recurrence or death in the combination arm and Keytruda-only arm, with a median follow-up of 23 and 24 months, respectively.
The 12-month recurrence-free survival (RFS) rates stood at 83.4% and 77.1%, and 18-month RFS rates reached 78.6% and 62.2% in mRNA-4157 plus Keytruda and Keytruda-only arms, respectively.
The incidence of Grade 3 or worse adverse events was found to be 25% vs. 18% in those in the combination therapy and the monotherapy arms, respectively, with fatigue (60.6%), injection site pain (55.8%) and chills (50.0%) being most common adverse events.
In 2023, Merck (MRK) and Moderna (MRNA) expect to begin a Phase 3 trial for the combination therapy in adjuvant melanoma before expanding studies to additional cancer types, such as non-small cell lung cancer.
The data were part of a presentation at the ongoing American Association for Cancer Research (AACR) Annual Meeting 2023.
Ahead of the readout, Merck (MRK) announced a buyout deal to acquire the immunology-focused biotech Prometheus Biosciences (RXDX) for nearly $11B in cash.
Posting initial results, Merck (MRK) and Moderna (MRNA) said in December KEYNOTE-942 met the primary endpoint of RFS with a statistically significant and clinically meaningful improvement.