> Moderna, Inc. (MRNA) up 120% today

Merck, Moderna’s personalized cancer vaccine slows recurrence in phase 3, setting up approval push

https://www.fiercebiotech.com/biotech/m … ph-3-trial

Merck & Co. and Moderna's personalized mRNA cancer vaccine has successfully lengthened recurrence-free survival (RFS) when paired with Keytruda for patients with high-risk skin cancer. The phase 3 win sets the partners up to potentially seek accelerated approval.

The INTerpath-001 trial enrolled 1,137 patients who had previously had their cutaneous melanoma surgically removed. These patients either received intismeran autogene—alternatively known as V940 or mRNA-4157—along with Keytruda, or Keytruda alone. The companies didn't provide specific data this morning, but did say that the improvements in both RFS as well as a secondary endpoint of prolonging survival without a distant metastasis had been “statistically significant and clinically meaningful.”

The partners observed no new safety signals in the trial, according to the Aug. 19 release.

Intismeran is customized for each patient, providing mRNA instructions to help the immune system hunt down as many as 34 different targets found on a patient’s tumors.

“For many years, the idea of creating an mRNA treatment designed specifically for an individual patient's cancer was aspirational,” Moderna CEO Stéphane Bancel said in the release. “We are now helping turn that vision into a reality.”

The results come from a preplanned interim analysis, with the trial now set to continue so that overall survival can be analyzed down the line. In the meantime, the companies said they plan to present the trial data at an upcoming international medical meeting, as well as “engage with regulators on filing submissions for intismeran autogene in combination with Keytruda.”

Speaking to investors during a second quarter earnings call last month, Moderna President Stephen Hoge, M.D., said that a positive interim readout “would obviously make the case for an accelerated review.”

Moderna previously sought accelerated approval for the cancer vax in 2024, but was rebuffed by the FDA.

“These first phase 3 findings for intismeran in combination with Keytruda as adjuvant therapy reinforce the promise of a more personalized approach to cancer treatment,” Dean Li, M.D., Ph.D., president of Merck Research Laboratories, said in this morning's release. “We believe individualized neoantigen therapies have the potential to redefine how patients with completely resected stage IIB-IV melanoma are treated.”

In a note to investors yesterday, analysts from Citi suggested that a statistically significant RFS hazard ratio equal to or below 0.72 would be “positive,” with a figure at or below 0.65 “representing a clear win.” A ratio of 0.65 would mean the experimental treatment combo reduced the risk of recurrence by 35% compared to Keytruda and placebo.

In an earlier phase 2 trial, intismeran posted an RFS hazard ratio of 0.51 at the five-year mark, though the Citi analysts noted yesterday that “some compression” from this number would be expected given the phase 3 study’s broader patient population and the possibility of disease recurrence before intismeran reaches patients.

Meanwhile, Jefferies analysts offered their own take last month, suggesting that an RFS hazard ratio between 0.5 and 0.8 “should be meaningful,” with positive results likely boding well for intismeran’s slew of other ongoing phase 2 and 3 trials in a variety of solid tumors.

The melanoma win follows Moderna’s triumphant recent approval for the first-ever mRNA flu vaccine, which came after the FDA initially—and controversially—refused to review the biotech’s application.

The pioneering mRNA company’s oncology chief told Fierce last year that Moderna was focusing more on its cancer pipeline in the wake of the Trump administration’s more skeptical attitude to vaccines.

Citi analysts wrote yesterday that Moderna’s pipeline is “still largely a show-me story.” A “clean result” for intismeran would bolster confidence in the company's strategy, the analysts suggested, “although broader execution and commercial questions would remain.”

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