After decades of slow progress, a personalized cancer vaccine has shown a clear benefit in a phase 3 trial for the first time. Cancer leaders are now weighing how soon a vaccine built from a patient’s own tumor could become part of routine care.
When added to immunotherapy after surgery, an mRNA vaccine called intismeran autogene cut high-risk melanoma patients’ risk of recurrence or death by 42% compared with immunotherapy alone, according to phase 3 trial results presented Oct. 24 at the European Society for Medical Oncology Congress 2026 in Madrid. The benefit widened over time: Once patients completed the vaccine regimen, a sensitivity analysis showed a 58% lower risk of recurrence or death.
The results arrive as the NIH prepares to launch a public-private cancer vaccine research partnership in December.
Becker’s asked nine oncology leaders what stands between cancer vaccines and routine care and how soon they could get there.
Editor’s note: Responses have been lightly edited for clarity and length.
Question: What will it take for cancer vaccines to become standard care, and how far off are we?
Richard Barakat, MD. Physician-in-Chief and Executive Director of Northwell Health Cancer Institute (New Hyde Park, N.Y.): Intismeran provides clinically meaningful evidence that personalized cancer vaccination using mRNA technology can improve outcomes. I expect it will strengthen individualized neoantigen therapy as a key option, though wide adoption will require solving production logistics and cost, expanding access beyond tertiary cancer centers and addressing stigma around mRNA vaccines. Despite these hurdles — supported by melanoma results and ongoing work across multiple tumor types — I’m optimistic that personalized cancer vaccines will become a viable and standard part of cancer immunotherapy in the coming years.
Monica Baskin, PhD. Director of VCU Massey Comprehensive Cancer Center (Richmond, Va.): In order for cancer vaccines to become standard of care, we must tackle patient, provider and health system barriers. We are closer than we have ever been. Cancer prevention vaccines like HPV and hepatitis B are already standard care and have made a difference in cancer incidence. In addition, new therapeutic cancer vaccines are showing promise in clinical trials, which may lead to future recommendations. But we still have quite a way to go.
Robert Figlin, MD. Associate Dean of Cedars-Sinai Cancer Care (Los Angeles): Cancer vaccines are a promise that translates discovery to translation to standard of care. The vaccines must undergo the same scrutiny of all other therapeutics with the demonstration of clinical benefit. The additional challenge with these vaccines is to be sure that the observed outcomes are from the autologous vaccine and not just a byproduct of the vaccine backbone leading to these benefits. Well-controlled randomized trials that tease out the component benefits are necessary, as the promise of vaccines is a long time promised but yet to deliver without questions.
Sajid Khan, MD. Section Chief of Hepato-Pancreato-Biliary and Mixed Tumors at Yale School of Medicine; Co-Director of Team Science at Yale Center for Clinical Investigation; Co-Program Leader of Advanced Hepatobiliary Disease at Yale Cancer Center (New Haven, Conn.): To become standard care, cancer vaccines must consistently demonstrate long-term recurrence and distant metastasis reductions over immunotherapy alone, as shown by the phase 3 INTerpath-001 trial’s 42% risk reduction and sustained post-treatment efficacy. While these robust phase 3 results bring us significantly closer, broader clinical adoption will require completing these regimens across diverse patient subgroups and confirming longer-term overall survival benefits in postsurgical settings.
Ruben Mesa, MD. President of the Cancer National Service Line and Senior Vice President at Advocate Health (Charlotte, N.C.); Executive Director of Atrium Health Wake Forest Baptist Comprehensive Cancer Center (Winston-Salem, N.C.): The results presented at ESMO in melanoma are very compelling and will likely change practice for melanoma. I think it lays the groundwork proving future cancer vaccine effectiveness [through] randomized trials against current state-of-the-art therapy. Every type of cancer may have relevant differences of vaccine responsiveness, so it will be important to have disease-specific proof — the results in melanoma are encouraging, but melanoma might be more responsive than other tumor types — and [proof the vaccine is] superior as monotherapy or combination compared to current standard of care.
Kimryn Rathmell, MD, PhD. CEO of the Ohio State University Comprehensive Cancer Center-Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (Columbus, Ohio): I am thrilled to see this pivotal transition come to fruition for cancer therapy. The time is right for personalized vaccines to accompany the widespread adoption of checkpoint inhibitor therapy. The challenges of optimizing target identification, customized manufacturing at scale, the need for new regulatory pathways and, of course, cost are all achievable. We should anticipate rapid progress in this space within the next few years. This treatment really fits the definition of personalized care.
Diane Simeone, MD. Director of Moores Cancer Center at University of California San Diego Health (San Diego): The potential use of cancer vaccines in certain clinical settings is exciting. The need to advance their validation in terms of improved cancer outcomes will require additional investment. Comparison of personalized versus off-the-shelf vaccine strategies will be important to assess performance, the economics of their use and the ability of these therapeutics to reach into the community, where many cancer patients get their care. The Foundation for the National Institutes of Health’s planned strategy to test cancer vaccines in earlier disease settings — neoadjuvant and adjuvant — is going to be a great next step.
Theodoros Teknos, MD, PhD. President and Scientific Director of the Seidman Cancer Center at University Hospitals; Deputy Director of the Case Comprehensive Cancer Center (Cleveland): While this trial is a remarkable step forward, the path to having this approach be the standard of care for all cancers will be challenging. Melanoma is the ideal tumor for this approach, as it is highly immunogenic, responds to Keytruda as a single agent, has a high tumor mutational burden and expresses over 30 neoantigens. Other tumors are less immunogenic, or “cold tumors,” and may not benefit from this approach.
There are also logistical considerations which may limit widespread adoption of this approach:
- The significant cost of creating the vaccine ($300,000 per patient)
- CMS and commercial insurance coverage of the treatment
- The seven-week time lag from tumor removal to the availability of the vaccine
- Lack of adequate viable tumor for vaccine creation in some tumor types
Realistically, due to regulatory and CMS approval timelines, the melanoma therapy should become available in 2027, but other tumor vaccines likely won’t become available until 2030 or beyond.
Sai Yendamuri, MD. Chief Strategy Officer and Chair of Thoracic Surgery at Roswell Park Comprehensive Cancer Center (Buffalo, N.Y.): While the presented results are great, the mechanics of identifying suitable patients, creating an individualized vaccine and deploying it in a practical standard-of-care community setting can be daunting. In addition, payer collaboration will be necessary for addressing affordability. I really look forward to progress in biomedical innovation going hand in hand with healthcare delivery innovation to make such novel therapies reachable to underserved communities.
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