Key Trial Breakthrough in Skin Cancer
The personalized mRNA cancer vaccine developed by Merck & Co. and Moderna has proven to extend patients’ recurrence-free survival (RFS) when combined with Keytruda for patients with high-risk skin cancer. The phase 3 victory helps put the partners in a position to apply for accelerated approval.
INTerpath-001 involved 1,137 patients with a history of surgical removal of their skin melanoma. The patients were either given intismeran autogene – also known as V940 or mRNA-4157 – combined with Keytruda, or given just Keytruda. The companies didn’t provide specific data this morning. Still, they 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 saw no new safety signals in the trial, the Aug. 19 release noted.
How Personalized mRNA Vaccines Work
Intismeran is tailored to a patient and delivers mRNA instructions to the immune system to target as many as 34 different targets that are present on the patient’s tumors.
The concept of developing an mRNA drug targeted to a specific patient’s cancer was a dream for many years, said Moderna CEO Stéphane Bancel in the release. “Today we’re contributing to making that vision a reality.”
The results are part of a planned interim analysis, and the trial is continuing for the purpose of analysing overall survival in the future. Meanwhile, the companies indicated that they would be submitting the trial data to regulators for intismeran in conjunction with Keytruda at a future international medical meeting, as well as the “engagement with regulators on filing submissions for intismeran in combination with Keytruda.”
Moderna President Stephen Hoge told investors in the second-quarter earnings call last month 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 initial phase 3 results of intismeran used with Keytruda as an adjuvant therapy further demonstrate the potential to treat cancer more individually, as Merck is dedicated to doing,” said Dean Li, president of Merck Research Laboratories in the release. “In our view, the new individualized neoantigen therapies could revolutionize the treatment of patients with stage IIB-IV melanoma who have had complete resection.
Analyst Expectations and Benchmark Numbers
Citi analysts in a note to investors yesterday recommended that a hazard ratio of 0.72 or lower “is positive” and one of 0.65 or lower is a “clear win.” A ratio of 0.65 translates to a 35% decrease in the likelihood of the recurrence with the experimental treatment combination versus Keytruda and Placebo.
In a prior phase 2 trial, the hazard ratio for intismeran was 0.51 at five years, but the analysts at Citi said yesterday that “some compression” would likely be seen in the phase 3 study because of the larger patient population and the fact that there could be several patients who would have recurred before intismeran has reached them.
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 victory comes on the heels of Moderna’s highly successful breakthrough approval of the world’s first-ever mRNA flu vaccine, just after the FDA initially, and controversially, rejected 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.
Merck and Moderna have reported positive Phase 3 results for their personalized mRNA cancer vaccine, Merck-partnered intismeran autogene, used with Merck’s Keytruda. The INTerpath-001 trial met its primary recurrence-free survival endpoint and its secondary distant metastasis-free survival endpoint in patients with completely resected high-risk melanoma.
The Merck and Moderna treatment was evaluated in 1,137 patients with stage IIB-IV melanoma following surgery. The companies said the combination produced statistically significant and clinically meaningful improvements compared with Keytruda alone.
Merck’s Personalized Cancer Vaccine Targets Melanoma
The Merck vaccine strategy uses personalized mRNA technology designed around characteristics of an individual patient’s tumor. The approach aims to train the immune system to recognize tumor-specific neoantigens that may remain after surgery.
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
