Cancer Vaccine ‘Closer Than We Ever Thought,’ 2025 Availability Possible

Personalized cancer vaccines are on the horizon and could be available for some patient populations as soon as next year, one expert said.

“We are way closer than we ever thought [we would be] just like three years ago,” said Dr. Patrick Ott, director of the Center for Personal Vaccines, clinical director of the Melanoma Disease Center and director of clinical sciences of the Center for Immuno-Oncology at the Dana-Farber Cancer Institute in Boston, as well as an attending physician in the department of medicine at Brigham and Women’s Hospital, an associate professor at Harvard Medical School and a member of the scientific advisory board of drug development company Imunon.

The enthusiasm is in the wake of the results of the phase 2b KEYNOTE-942/mRNA-4157-P201 study, announced in late 2023 by drug manufacturers Moderna and Merck, which found that patients with advanced-stage melanoma experienced reduced risk of recurrence or death following treatment with a combination of mRNA vaccine mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), and Keytruda, an anti-PD-1 therapy.

The combination reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 62% when compared with treatment with Keytruda alone in patients with stage 3 or 4 melanoma with a high risk of recurrence following complete resection.

The Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to the combination for the post-surgical treatment of patients with high-risk melanoma earlier this year based on the trial’s findings. Moderna and Merck have also launched the phase 3 INTERpath-002 trial evaluating the combination as a postsurgical treatment for patients with stage 2, 3A or 3B with nodal development non-small cell lung cancer, as well as V940-001, a phase 3 study evaluating mRNA-4157 and Keytruda as postsurgical treatment for stage 2B to 4 melanoma.

Elsewhere, immunotherapy company BioNTech is evaluating mRNA-based, individualized cancer vaccines in cancer types including colorectal and pancreatic cancers and melanoma, with Dana-Farber announcing in 2021 that Ott was leading its participation in one of the BioNTech clinical trials.

“When you talk about phase 3 trial or randomized phase 2 studies, it’s basically the two companies who also are known for mRNA vaccines, so it’s BioNTech and Moderna,” explained Ott, who said he has been working on the Moderna studies. “Moderna has partnered with Merck to do a series of phase 3 trials using these vaccines and different tumor types, including melanoma and lung cancer, but also other tumor types in the future. And that’s all public knowledge. They’re basically revving ramping up their manufacturing capabilities, because there’s even some hope in the field that one of these vaccines may even become like clinically available, meaning approved by the FDA, as early as in 2025, from what I heard. So basically, that’s maybe ambitious, but it’s a possibility.”


One of the main reasons why this is so exciting, I think, for the entire field, is because at least conceptually there’s no reason why this would not work in other cancers as well. And that’s exactly why, for example, with Moderna and Merck’s collaboration, why they already embarked on a lung cancer trial without having any randomized data in lung cancer before. So, there’s really not a similar phase 2 trial to what we have in melanoma in lung cancer and nevertheless, they go right into phase 3 in lung cancer. So that tells you that, well, we will find out. But at least from a conceptual point of view, and looking into biology, there’s reason to think that this may work not just in melanoma.

But I would also say we kind of have to be reasonable, right? We don’t know yet. And I think sort of taking it from the other side was like, ‘Oh, the vaccine should be employed for anyone where we don’t really have good other options.’ That’s not the way I see it. I think one first needs data and there has to be solid evidence that it works before it should be employed.

Transcript edited for clarity and conciseness.

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