By Senad Karaahmetovic
Moderna (NASDAQ:MRNA) and Merck (NYSE:MRK) announced the results of a closely-watched Phase 2b personalized cancer vaccine (PCV) trial for melanoma.
The results showed that the mRNA-4157 reduced the risk of recurrence or death by 44% compared with KEYTRUDA alone. Phase 3 study should start in the summer of 2023.
"Today's results provide further encouragement for the potential of mRNA as an individualized neoantigen therapy to positively impact patients with high-risk resected melanoma," said Dr. Kyle Holen, M.D. Moderna's Senior Vice President and Head of Development, Therapeutics and Oncology.
The additional data will be shared during the American Association for Cancer Research (AACR) Annual Meeting 2023 plenary session.
Brookline Capital Markets analysts said the first results were “stunning.”
“These results combined with the recently announced FDA Breakthrough Therapy Designation, and the anticipated phase III study initiation, support our outlook for the clinical progress and potential approval of this combination. Our outlook for mRNA-4157 is it could enter the market in 2026. We estimate that worldwide mRNA-4157 sales will increase to $9.94 billion by 2030, making it the fourth largest contributor to Moderna’s 2030 sales. We also believe this success in a cancer setting further de-risks Moderna cancer development platform,” they said in a note.
Cantor Fitzgerald analysts also see the data as “impressive.” Focused on the impact for Merck stock, the analysts said the positive data could “drive even more excitement/ enthusiasm for this asset, and upside to Street expectations, in our view.”
Moderna shares are up 3.5% in premarket Monday.