The experimental mRNA vaccine, when combined with Merck’s blockbuster drug Keytruda, reduced the risk of melanoma recurrence by 44% when compared to Keytruda alone, the companies reported Sunday in their first detailed presentation of results from a crucial phase two trial.
According to the companies, nearly 80% of participants who received both the vaccine and Keytruda remained cancer-free for 18 months, compared to 62% of participants who received only Keytruda. They added that the vaccine’s adverse effects were generally mild, with fatigue being the most prevalent.
Moderna’s mRNA vaccine and Merck’s Keytruda treated melanoma.
These results, which were presented at a meeting of the American Association for Cancer Research in Florida, supplement the initial findings on the treatment combination that were published in December.
Dr. Kyle Holen, head of development, therapeutics, and oncology at Moderna, said in a press release that the results imply the vaccine in combination with Keytruda “may be a novel way to potentially extend the lives of patients with high-risk melanoma.”
Moderna and Merck have stated that they will launch a phase three trial in 2023 and “rapidly expand” their research to examine the treatment’s efficacy on additional tumor types, including a significant form of lung cancer.
Wall Street analysts reacted cautiously.
According to analysts from SVB Securities, the results indicate that the personalized cancer vaccine is promising. In addition, they stated in a note published on Sunday that the treatment’s path to approval is novel and untested, and that the company does not believe that accelerated approval is possible.
The accelerated approval designation of the Food and Drug Administration is intended to expedite the clearance of drugs for serious conditions that serve an unmet medical need.
Tim Anderson, an analyst at Wolfe Research, wrote on Monday that many Moderna and Merck stakeholders remain “cautiously optimistic at best” regarding the potential of the cancer vaccine-Keytruda combination.
He stated that expectations for the treatment combination were moderately high heading into the weekend, but noted that there are still numerous cancer vaccine skeptics due to a “long history of failures in this space.”
In addition, Wells Fargo analyst Mohit Bansal expressed “cautious optimism” regarding the treatment combination. In a note published on Sunday, Bansal cited “trial imbalances” that may have led to more favorable results for the personalized cancer vaccine.