New york: Merck and Moderna's experimental personalized cancer vaccine has delivered positive results in its first phase three trial, the companies announced Wednesday, moving the treatment closer to potential regulatory approval.
According to Anadolu Agency, the mRNA vaccine, combined with Merck's Keytruda, met the main goals of a study involving more than 1,100 patients with high-risk or advanced melanoma whose tumors had been surgically removed. The combination significantly extended the time patients remained free of melanoma compared with Keytruda alone and lowered the risk of the cancer spreading elsewhere.
The companies plan to present the findings at an upcoming medical meeting. The trial will continue to evaluate overall survival, while the timing of US approval applications remains unclear. The results could establish the combination as a new option for melanoma, which represents about 1% of skin cancers but causes most skin cancer deaths. Most melanoma recurrences occur within two to three years of initial treatment.
Melanoma patients are often faced with the reality of the diagnosis and the subsequent need for treatments like surgery. Dr. Jane Healy, Merck's head of oncology early development, noted that patients are concerned about the potential return of their cancer. She described the results as promising, highlighting an improvement over Keytruda, the standard melanoma treatment. The therapy was generally well-tolerated, with side effects similar to those associated with routine vaccines.
The vaccine is designed to target mutations unique to each patient's tumor, aiming to train the immune system to recognize and destroy those cancer markers, while Keytruda enhances the immune response. Dr. Healy emphasized the significance of these results for melanoma patients and the potential implications for other cancer patients in future trials with this new class of therapy.