Moderna and Merck reported the success of an experimental melanoma vaccine
Moderna and Merck reported positive results from Phase III trials of a personalized mRNA therapy for melanoma. The combination of the investigational drug intismeran autogene and the immunotherapy Keytruda showed better results than Keytruda alone.
The INTerpath-001 study was conducted among patients with stage IIB-IV melanoma whose tumors had been completely removed surgically but who remained at high risk of disease recurrence.
According to the companies, the therapy met the primary endpoint of the study - it extended the recurrence-free survival period. It also met one of the key secondary endpoints - it extended the period without distant metastasis.
Moderna and Merck say that the improvements in both measures were statistically significant and clinically meaningful compared to treatment with Keytruda alone. However, the companies have not yet disclosed detailed numerical results from the Phase III trial. They plan to present them at one of the upcoming international medical congresses.
Intismeran autogene, also known as mRNA-4157 or V940, is often called a personalized cancer vaccine. Technically, it is an individualized neoantigen therapy based on mRNA. For each patient, the drug is created separately based on the set of mutations in their tumor.
The resulting mRNA is intended to teach the immune system to recognize proteins specific to the patient's tumor and to attack cells containing them. The drug is used together with Keytruda - Merck's pembrolizumab, which helps the immune system recognize cancer cells more effectively.
Previous results already indicated the potential of this approach. In June, Moderna and Merck released five-year data from a Phase II study of patients with stage III-IV melanoma. At that time, the combination of intismeran autogene and Keytruda reduced the risk of recurrence or death by 49%, and the risk of distant metastasis or death by 59% compared to Keytruda.
It is important to note that these figures pertain to the earlier Phase II trial. The companies have not yet released detailed data from the current Phase III trial.
Moderna and Merck now plan to discuss the results with regulators and the possibility of submitting a registration application for the therapy. Previously, the FDA granted the combination Breakthrough Therapy designation for certain patients with high-risk melanoma, and the European Medicines Agency included it in the PRIME program.
The success of the trials has sparked a strong reaction in the stock market. According to MarketWatch, Moderna's stock rose 177% on August 19, marking the largest one-day jump in the company's history. Merck's shares also rose significantly. Investors view the results as confirmation of the potential of mRNA technology beyond vaccines against infectious diseases.
Intismeran autogene is being tested not only in melanoma. Moderna and Merck are investigating personalized mRNA therapy in lung, kidney, bladder, and other cancers.
Based on: Moderna, Merck, MarketWatch
