Moderna and Merck have announced positive results from a phase 2 clinical trial of a personalized cancer vaccine, mRNA-4157 (also known as V940), in combination with Merck’s Keytruda (pembrolizumab). The trial studied patients with high-risk resected melanoma – a type of skin cancer. It showed that those who received the combination treatment had a statistically significant and clinically meaningful improvement in recurrence-free survival compared to those who received Keytruda alone.
As of now, Keytruda is known to treat several types of cancer by targeting and blocking the PD-1 protein on cancer cells, allowing the immune system to better recognize and attack the cancer cells. It has been approved for use in various cancers, including melanoma, lung, head and neck, and more. Keytruda can be used alone or in combination with other treatments and is administered intravenously by a healthcare provider.
mRNA-4157 is a personalized vaccine, designed to target neoantigens specific to an individual patient’s tumor. Neoantigens are abnormal proteins that are present on the surface of cancer cells but not on normal cells, making them a promising target for cancer treatment. By targeting neoantigens, mRNA-4157 aims to activate the immune system to recognize and attack cancer cells.
The phase 2 clinical trial included 123 patients with high-risk resected melanoma. Patients were randomized to receive either mRNA-4157 in combination with Keytruda or Keytruda alone. The primary endpoint of the trial was recurrence-free survival, which is the length of time a patient remains cancer-free after treatment. The trial met its primary endpoint, with patients who received the combination treatment having a statistically significant and clinically meaningful improvement in recurrence-free survival compared to those who received Keytruda alone.
The combination treatment was generally well-tolerated, with the most common side effects being fatigue, injection site reactions, and fever. There were no treatment-related deaths reported in the trial. The results are considered promising, as there are currently limited treatment options available for high-risk resected melanoma. While Keytruda has shown efficacy in treating melanoma, not all patients respond to the drug, and there is a need for additional treatment options.
Moderna and Merck plan to continue studying mRNA-4157 in larger patient populations to further evaluate its efficacy and safety. The companies are also studying mRNA-4157 in combination with other cancer therapies, including Merck’s Lenvima (lenvatinib) and Eisai’s Halaven (eribulin).
Personalized cancer vaccines like mRNA-4157 have the potential to revolutionize cancer treatment by targeting specific mutations in a patient’s cancer cells. However, developing these vaccines is a complex and time-consuming process, as each vaccine must be tailored to an individual patient’s unique genetic profile. Despite these challenges, personalized cancer vaccines have shown promise in clinical trials and are an area of active research and development in oncology.
The positive results from the phase 2 clinical trial of mRNA-4157 in combination with Keytruda represent a promising advance in the treatment of high-risk resected melanoma. The results are encouraging and suggest that personalized cancer vaccines may have an important role to play in the future of cancer treatment.
