Moderna and Merck report mRNA cancer vaccine cuts melanoma recurrence risk in late-stage trial

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Moderna and Merck report mRNA cancer vaccine cuts melanoma recurrence risk in late-stage trial
Moderna shares surge over 150% after positive melanoma vaccine trial results: U.S. Treasury doubles bond buybacks
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Moderna and Merck announced on Wednesday that a personalized mRNA cancer vaccine, developed jointly, reduced the risk of recurrence and spread of melanoma in a late-stage trial involving over 1,100 patients. The vaccine, called Intismeran, was tested in combination with Merck’s immunotherapy drug Keytruda and demonstrated a "clinically meaningful improvement" over Keytruda alone, according to the companies .
The trial focused on patients with high-risk melanoma that had been surgically removed but carried a significant risk of returning. Moderna President Stephen Hoge said thousands of melanoma patients could benefit within the first few years of approval, pending regulatory clearance . The companies plan to submit the full results at an upcoming medical meeting and have begun discussions with regulators .
Moderna’s stock surged as much as 177% on Wednesday, while Merck’s shares rose 12.6% following the announcement . The vaccine represents the first positive Phase 3 results for an mRNA-based cancer therapy, the companies stated in a joint release .
The trial divided 1,137 patients into groups, with two-thirds receiving the vaccine alongside Keytruda and the remainder treated with Keytruda alone. Study leader Georgina Long, medical director of the Melanoma Institute Australia, called the results a "milestone in the adjuvant treatment" of melanoma .
Beyond melanoma, the companies are conducting late-stage trials for non-small cell lung cancers and mid-stage trials for bladder and kidney cancers, with early-stage studies underway for pancreatic and stomach cancers. Additional results are expected in the next one to two years, Hoge told Reuters . Roche and BioNTech are also testing a similar mRNA-based treatment, autogene cevumeran, in mid-stage studies for colon and pancreatic cancers, with colon cancer trial results anticipated in 2027 .
The safety profile of the combination treatment aligned with earlier studies, showing no new risks, according to Hoge . The companies did not specify a timeline for regulatory approval but indicated they are preparing submissions to authorities.
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![Moderna and Merck shares soar on mRNA cancer vaccine Moderna and Merck shares soared on Wednesday after the companies said a personalized mRNA treatment hit its target of preventing skin cancer from recurring or spreading in a late-stage clinical trial. Why it matters: The results come at a pivotal moment for Moderna and mRNA research, after Trump administration health officials cut federal funding for new vaccines and asserted the technology poses more risks than rewards.The customized therapy, which could see a commercial launch next year, could also be adapted for other cancers of the kidney, bladder and pancreas.The big picture: The results could lead to a remarkable turnaround for Moderna, whose market value plummeted more than 90 after demand for its COVID vaccine declined post-pandemic. The company this month also won Food and Drug Administration approval for a new mRNA seasonal flu vaccine."People will experience this as ... the COVID company now [takes on] cancer," Moderna president Stephen Hoge told Axios. "But for those of us that live in it, its like the cancer company that pivoted on a dime to help with COVID has pivoted back and really finally come home."Driving the news: Modernas experimental therapy, called intismeran, was tested in combination with Mercks cancer drug Keytruda in more than 1,100 patients with high-risk melanoma that had been surgically removed.The combination demonstrated a "clinically meaningful improvement" over treating the skin cancers with Keytruda alone.The mRNA-based drugs essentially train the immune system to find mutations in a patient that cause tumors. Thats a contrast to chemotherapy, which damages or destroys cancer cells."We may be entering an era where a patients individual tumor biology can be used to design a therapy specifically for them," William Soliman, founder and CEO of the Accreditation Council for Medical Affairs, said in an email.The latest: The full results of the trial will be released at an upcoming medical meeting. But Wall Street has already responded enthusiastically, with shares of Moderna surging 177 Wednesday, while Merck shares closed up 12.6."This is a landmark moment," TD Cowen analysts wrote in an investor note. "We view the result as a significant validation of the ... platform." Between the lines: The safety profile of the combination treatment was consistent with earlier studies and showed no new risks.The findings showed early cancers might be treated more aggressively than with prior treatments that were more toxic to the body, Hoge said.What were watching: Whether the potential success of an mRNA-based cancer therapy could help lift the bigger cloud hanging over the technology. Political backlash following the pandemic — including the Trump administration pulling nearly $500 million in federal funding for mRNA research — raised questions about the fields long-term prospects.The FDA initially refused to review Modernas mRNA flu vaccine before changing course."I do hope that this will move people away from pigeonholing mRNA as a vaccine platform, or maybe even more incorrectly, tying it to the things they didnt like about the pandemic era that had nothing to do with the technology," Hoge said."I hope this starts to move us past that because it is, we think, a transformational moment in cancer."](https://images.axios.com/37lchMmq5jskTpVpcWScxJHTrVs=/0x0:4832x2718/1366x768/2026/08/19/1787168992152.jpeg)



