Moderna Inc (NASDAQ:MRNA) shares surged more than 90% in Wednesday pre-market trading after the biotechnology company and Merck (NYSE:MRK) reported positive Phase 3 results for their melanoma treatment combination, which performed better than Keytruda alone.
The INTerpath-001 study evaluated intismeran autogene, an investigational mRNA-based individualised neoantigen therapy, in combination with Merck’s Keytruda in patients with completely resected stage IIB-IV melanoma. The trial achieved its primary endpoint of recurrence-free survival, as well as the key secondary endpoint of distant metastasis-free survival.
“We are upgrading shares to Outperform from Market Perform given that we believe Moderna has a clear line of sight to revenue diversification from the COVID business now,” William Blair analyst Myles Minter said in a note.
Compared with Keytruda alone, the combination delivered statistically significant improvements across both measures in patients with completely resected stage IIB, IIC, III or IV cutaneous melanoma who had not previously received systemic therapy.
The results represent the first successful Phase 3 readout for an individualised neoantigen therapy and an mRNA-based cancer treatment. The study is also the first Phase 3 trial to demonstrate a clinically meaningful improvement over Keytruda alone in the adjuvant treatment of patients with resected melanoma.
No new safety concerns emerged from the trial, with the safety profiles of intismeran and Keytruda remaining consistent with findings from earlier studies. Researchers will continue assessing additional key secondary endpoints, including overall survival.
Moderna and Merck intend to present the findings at a forthcoming international medical conference and submit the results to regulatory authorities.
The two companies are also evaluating their treatment approach more broadly, with nine Phase 2 and Phase 3 trials currently underway across several tumour types. These include melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma.
Moderna stock price
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