The combination of Keytruda and an mRNA vaccine reduced the risk of death or relapse in patients with the most deadly form of skin cancer after three years in a Phase IIb study.
Pictured: Moderna headquarters in Massachusetts/iStock, hapabapa
A combination of Merck’s blockbuster cancer drug Keytruda and an mRNA vaccine from Moderna has demonstrated positive results at the three-year stage in a Phase IIb study of patients with resected high-risk melanoma following complete resection.
Moderna and Merck on Thursday revealed the data from a Phase IIb of the Keynote-942 study evaluating Moderna’s vaccine known as mRNA-4157, which is an individualized neoantigen therapy, combined with Merck’s anti-PD-1 in patients with resected high-risk melanoma.
Moderna touted the data, stating that the combination demonstrated a “clinically meaningful improvement” in recurrence-free survival after a three-year follow-up. In recurrence-free survival, the combination reduced the risk of recurrence or death by 49% when put up against Keytruda alone. This earned the combination a p-value of p=0.0095.
The combination also showed a “meaningful improvement” in distant metastasis-free survival, reducing the risk of the development of distant metastasis or death by 62% and nabbing a p-value of p=0.0077.
Moderna’s stock price jumped 11% on Thursday morning before the opening bell.
“These data add another positive analysis to the multiple endpoints and subgroups previously assessed in this study. Importantly for this technology, the Keynote-942/mRNA-4157-P201 study was the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and the first combination therapy to show a significant benefit over Keytruda alone in adjuvant melanoma,” Kyle Holen, Moderna’s senior vice president and head of development for therapeutics and oncology, said in a statement.
The adverse events for the combination have remained consistent, with the most common reported side effects being fatigue, pain where the injection was made, and chills.
The combination has already been granted Breakthrough Therapy Designation by the FDA and is a part of the EMA’s priority medicine scheme. A Phase III trial for the combo was already launched in July 2023 and another Phase III study is also underway for a Keytruda, mRNA-4157 combo to treat non-small cell lung cancer. Moderna noted in a release that there is a plan to expand the development program into other tumors.
Moderna and Merck have been revealing data for its combo since last year when, in December 2022, it was announced that the vaccine had reached its primary endpoint of recurrence-free survival, reducing death or recurrence by 44%. More results were released at ASCO in June 2023, showing a reduction of the development of metastasis or death by 65%.
While Keytruda has continued securing further label extensions from the FDA this year, Moderna is looking to shift its business away from COVID-19. In Moderna’s third-quarter results, overall sales were $1.8 billion—down from $3.4 billion in the prior year—due to a “lower sales volume.” Moderna is also looking to forge ahead with other vaccines, particularly in RSV, which was submitted for further authorization over the summer.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
