Technology and Scienceupdated 56m ago2 min read
Merck And Moderna’s Intismeran Autogene With Keytruda Cuts Melanoma Death Or Recurrence Risk 42%
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Phase 3 trial shows vaccine plus Keytruda cuts melanoma death or recurrence by 42%. Over 1,100 patients participated in the INTerpath-001 study.
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42% Melanoma Risk Cut
Merck and Moderna said their mRNA cancer vaccine, intismeran autogene, when combined with Merck’s immunotherapy Keytruda, cut the risk of melanoma death or recurrence by 42% in a large trial. The Phase 3 trial included 1,137 patients with stage IIB–IV melanoma that had been surgically removed before entering the study. Moderna CEO Stéphane Bancel said in a statement, "From the beginning, we believed mRNA technology could make it possible to develop cancer treatments uniquely matched to each patient’s tumor," as the companies prepared to seek approval.
The trial also showed the combination cut the risk of the cancer’s spread by 38% compared with Keytruda alone. The companies are preparing to file for US approval and expect the cancer vaccine to launch in 2027, with results scheduled for presentation on Saturday at the European Society for Medical Oncology meeting in Madrid.
Leak Triggers Market Shock
Moderna shares fell over 20% after results leaked on an oncology website earlier on Thursday, while Merck shares were down about 0.7%, according to Devdiscourse. Moderna’s shares plunged as much as 26% intraday on Thursday, while Merck’s fell 3.9%, after Merck confirmed that data slated for publication had been leaked. Merck confirmed in a phone call that some results from the study had been disclosed earlier than planned, and it described details surfacing from unverified X sources.
Moderna shares closed more than 17% lower after the results leaked on an oncology website earlier on Thursday, and Merck shares closed down about 1.8%. KELO-AM, citing Reuters, said the selloff wiped out about $24 billion from Moderna’s market value and described analysts calling it a “sell-the-news” reaction.
Trial Design and Next Steps
The experimental vaccine, called intismeran autogene until it receives a brand name, was given as an intramuscular injection every three weeks for up to nine doses, while Keytruda was administered via intravenous infusion every six weeks for up to about a year. The trial results showed a 42% reduction in the risk that cancer recurred from a median of about two years after treatment, and the trial would continue to assess durability and overall survival. The trial tested nine doses of the vaccine beginning 13 weeks after surgery to remove melanoma lesions, and it compared the combination against patients treated with just Keytruda.
Among those who received the vaccine in addition to Keytruda, 82.2% were still cancer-free after two years, compared with 70% of patients who received Keytruda alone. The full data has been accepted for publication in the New England Journal of Medicine, and the companies were already engaging with regulatory authorities to get the vaccine approved.