'Unlikely' Moderna can file for accelerated approval says analysts; Shares jump 12% By

(Updated - December 14,bfs Niuhui 2023 10:38 AM EST)

(NASDAQ:) shares rose more than 12% today after the company said its vaccine candidate, developed together with Merck (MRK) cuts the risk of skin cancer returning by nearly half.

According to the press release, mRNA-4157 (V940) in combination with KEYTRUDA demonstrated promising results.

The treatment reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 62% compared to KEYTRUDA alone in stage III/IV melanoma patients with a high risk of recurrence post-complete resection.

These findings build on the primary analysis reported at AACR and ASCO in 2023, showing a 44% reduction in the risk of recurrence or death and a 65% reduction in the risk of distant metastasis or death at a median planned follow-up of approximately two years.

The companies have initiated Phase 3 studies in the adjuvant setting for patients with high-risk melanoma and non-small cell lung cancer, with plans to expand to additional tumor types rapidly.

"As we continue to follow participants in the KEYNOTE-942/mRNA-4157-P201 study, we are excited to see such a robust clinical benefit with mRNA-4157 (V940) as adjuvant treatment in combination with KEYTRUDA in people with resected high-risk melanoma," said Kyle Holen, M.D., Moderna's Senior Vice President and Head of Development, Therapeutics and Oncology.

Jefferies analysts weighed in on the results.

"This is an overall incremental (+) and MRNA will now likely speak with FDA on next steps and question then becomes if they can file for accelerated approval. We think unlikely given this is only a Phase II and FDA might want data from Phase III to get a better sense on the benefit given some baseline imbalances in the Phase II," they said in a note.

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