An experimental personalized mRNA cancer vaccine jointly developed by Moderna and Merck & Co. demonstrated a reduction in the risk of disease recurrence or death when used in combination with Merck's Keytruda in a phase 2 study of melanoma patients.
The partners announced that the phase 2b KEYNOTE-942/mRNA-4157-P201 trial of mRNA-4157/V940 in combination with Merck's anti-PD-1 therapy, Keytruda, demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of recurrence-free survival (RFS) versus Keytruda alone for the adjuvant treatment of patients with stage III/IV melanoma following complete resection. Adjuvant treatment with mRNA-4157/V940 in combination with Keytruda reduced the risk of recurrence or death by 44% compared with Keytruda alone.
Back in Oct., the companies announced that Merck had put up $250 million to exercise its option to jointly develop and commercialize mRNA-4157/V940. Merck and Moderna will share costs and any profits equally under this worldwide collaboration.
"Today's results are highly encouraging for the field of cancer treatment. mRNA has been transformative for COVID-19, and now, for the first time ever, we have demonstrated the potential for mRNA to have an impact on outcomes in a randomized clinical trial in melanoma," said Stéphane Bancel, Moderna's Chief Executive Officer.
According to Moderna, the partners will begin additional studies in melanoma and other forms of cancer with the goal of bringing individualized cancer treatments to patients. The companies plan to discuss the most recent results with regulatory authorities and initiate a phase 3 study in melanoma patients in 2023.