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Moderna and Merck’s experimental mRNA Cancer Vaccine combination with pembrolizumab gets FDA Breakthrough Therapy Designation

US-based multinational vaccine giants, Moderna and Merck, have recently announced that mRNA-4157/V940, an investigational personalised mRNA cancer vaccine, in combination with Merck’s anti-PD-1 chemotherapy drug pembrolizumab, marketed as Keytruda, has been granted Breakthrough Therapy Designation by the United States Food and Drug Administration (FDA) for the adjuvant treatment of patients with high-risk melanoma following complete removal of the affected tissues surgically.

In a joint media statement, the companies said that an FDA designation has been received based on the results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial.

“The FDA’s Breakthrough Designation for mRNA-4157/V940 in combination with Keytruda reflects the excitement that we have for the potential promise of individualized cancer treatments,” Moderna’s President Dr Stephen Hoge, said.

“mRNA-4157/V940 in combination with Keytruda provided the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomised clinical trial and potentially represents a new frontier in treating melanoma and other cancers,” he added.

The Moderna Chief added that the companies are looking forward to publishing the full data set and that they will share the results at an upcoming oncology medical conference, as well as continuing discussions with health authorities.

Commenting on the FDA grant of Breakthrough Therapy Designation, Dr Eric H. Rubin, senior vice president, of global clinical development, at Merck Research Laboratories,  said, “This is an important milestone in the development of mRNA-4157/V940 in combination with  Keytruda.”

“We look forward to working with the FDA, in collaboration with Moderna, to conduct a rigorous and rapid clinical development program with a focus on addressing the needs of this important patient population,” he added.

The FDA’s Breakthrough Therapy Designation is granted to expedite the development and review of drugs intended to treat serious conditions, and when preliminary clinical evidence indicates that the product may demonstrate substantial improvement over available therapies on at least one clinically significant endpoint.

The companies stated that they will continue to discuss the results with regulatory authorities, initiate a Phase 3 study in adjuvant melanoma in 2023, and rapidly expand to additional tumour types, including non-small cell lung cancer.

Personalised cancer vaccines are designed to prime the immune system so that a patient can generate a tailored antitumor response based on the kind of mutation that occurs in their tumours.












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