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Phase 3 melanoma breakthrough
Merck and Moderna said in a joint press release on Wednesday, August 19 that their experimental messenger RNA vaccine against skin cancer succeeded in the final phase of clinical trials for patients with advanced melanoma.
“This is the first positive phase 3 results announcement”
The companies said the personalized therapy, named “autogeneic irMens antigen” (note: actual name in source appears as “intismeran autogene”), when combined with Merck’s Keytruda immunotherapy, significantly improved relapse-free survival compared with treatment with Keytruda alone, and they did so without publishing numerical data.
BFM reported the phase 3 clinical trial was conducted on more than 1,100 people, describing it as a decisive step before seeking regulatory approval.
Stéphane Bancel, Moderna’s chief executive, said in the press release, “For many years, the idea of creating an mRNA-based treatment specifically for an individual's cancer was hard to imagine. Today we are helping to turn this vision into reality.”
The announcement also triggered a market reaction, with BFM reporting that Moderna jumped in electronic trading ahead of the New York Stock Exchange opening (+65.18% around 11:40 GMT).
Independent monitors call it a success
BioPharma Dive said independent data monitors found that the cancer vaccine combined with Merck’s immunotherapy Keytruda showed “statistically significant and clinically meaningful improvements” over Keytruda alone at a pre-planned interim data check, allowing the companies to call the trial a success.
BioPharma Dive reported that the trial strategy used intismeran plus Keytruda or Keytruda alone after surgical removal, with investigators enrolling 1,137 people and two-thirds randomized to receive the intismeran-Keytruda combination.
In a separate account, CBC reported that Dr. Lennard Lee, a consultant medical oncologist and associate professor at Oxford, called the findings “significant,” while also warning 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.”
CBC added that the companies said they will present their results at an upcoming medical meeting and share them with regulators, while the trial is ongoing.
The same CBC report also noted that the treatment combines Merck’s Keytruda with a made-to-order mRNA vaccine from Moderna based on an analysis of mutations found in the patients’ own tumours.
Regulatory steps and next trials
After the interim results, the companies said they plan to present the data at an upcoming medical conference and begin regulatory steps to seek approval for the therapy, according to BFM.
“Merck and Moderna now plan to present these data at an upcoming medical conference”
BioPharma Dive said the clinical strategy focused on the adjuvant setting, and it described the approach as an “individualized antigen therapy” designed to detect up to 34 neoantigens on patients’ tumor cells.
CBC reported that the trial enrolled 1,137 high-risk patients with Stage 2B-4 melanoma that had been surgically removed, with volunteers randomized to receive up to nine doses of Keytruda plus the personalized vaccine or Keytruda alone for about one year.
In a statement carried by BFM, Stéphane Bancel framed the result as a shift from aspiration to reality, while CNBC quoted him saying, “It's a big moment for medicine, a big moment for patients,” during an interview on CNBC's “Squawk Box.”
The sources also tied the stakes to broader development, with BioPharma Dive saying the companies are testing the treatment against lung, kidney and bladder cancer, and with BFM noting melanoma is one of the deadliest forms of skin cancer with more than 330,000 new cases diagnosed worldwide in 2022.
