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Intismeran hits Phase 3
Merck and Moderna said Wednesday that a personalized mRNA melanoma vaccine called Intismeran, combined with Keytruda, met both its primary target of reducing cancer recurrence and its secondary goal of keeping cancers from spreading to other parts of the body in a late-stage trial.
“met both its primary target of reducing cancer recurrence and its secondary goal of keeping cancers from spreading”
CBC reported that the trial is ongoing, but interim results found the treatment met those goals compared with Keytruda alone, and the companies said they will present their results at an upcoming medical meeting and share them with regulators.
CNN said the treatment succeeded in the late-stage trial for melanoma, with Moderna CEO Stephane Bancel telling CNN that the results were “as big a day for humanity as Nov. 16, 2020,” when Moderna released late-stage clinical trial results showing its Covid-19 vaccine worked.
The trial enrolled 1,137 high-risk patients with stage 2b to 4 melanoma that had been surgically removed, and volunteers were randomized to receive up to nine doses of Keytruda plus the personalized vaccine or Keytruda alone for about one year, according to CBC and CNN.
Executives, investigators weigh in
On CNBC’s “Squawk Box,” Moderna CEO Stephane Bancel called it “a big moment for medicine, a big moment for patients,” while Merck Research Laboratories president Dr. Dean Li said the Phase 3 study will continue to assess other outcomes, including the overall survival benefit.
CBC quoted Melanoma Canada CEO Falyn Katz welcoming the results, writing, “This personalized mRNA therapy could offer patients at high risk of recurrence or metastasis a powerful new way to prevent melanoma from returning or spreading,” and said the organization “look[s] forward to seeing the full data.”
In a statement to CBS News, Professor Georgina Long, the study’s principal investigator and the chair of University of Sydney’s Melanoma Medical Oncology and Translational Research, said the results represent a “landmark moment” for adjuvant melanoma treatment.
CBS News also reported that the study tested intismeran in combination with Merck’s Keytruda, and that the drugs kept the cancer from returning for longer and prevented it from spreading to other organs, while the companies said no new safety signals have emerged.
What comes next
The companies said they plan to file for approval with regulators within months, though CNN reported they declined to provide a more specific timeline, and CBC said the trial is ongoing and the results will be shared with regulators.
“We do not yet have the magnitude of the Phase III benefit, the detailed subgroup analyses”
CBC also reported that Dr. Lennard Lee, a consultant medical oncologist and associate professor at Oxford who is not connected with the research, said the findings were “significant,” but warned that “We do not yet have the magnitude of the Phase III benefit, the detailed subgroup analyses, quality-of-life data or mature overall-survival results.”
In parallel, CNBC said the drugmakers will likely start talking to regulatory agencies about the treatment and its safety “in the next few months,” while also noting that it was unclear when they plan to submit applications for approval in the U.S.
CBS News added that the trial focused on people who had undergone surgery to remove a melanoma and tested the drug’s efficacy at reducing the risk of the cancer’s return, and it reported that more than 234,680 cases of melanoma will be diagnosed in the U.S. in 2026.
