Personalized mRNA Cancer Vaccines

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SUMMARY

Moderna and Merck are initiating Phase 3 trials for their mRNA cancer vaccine, mRNA-4157 (V940), in non-small cell lung cancer and other cancer types as of July 16, 2026. As of July 17, 2026, Evaxion will present three-year clinical efficacy data for its personalized cancer vaccine candidate, EVX-01, at the ESMO Congress 2026. The companies discontinued a Phase 2/3 adaptive study of mRNA-4157 combined with Keytruda for skin squamous cell cancer on May 8, 2026, but other studies continue. Five-year follow-up data from the KEYNOTE-942/mRNA-4157-P201 study on February 3, 2026, showed patients treated with mRNA-4157 and Keytruda had a 49% lower risk of recurrence or death compared to Keytruda alone.

Timeline

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July 2026 — 2 developments

  1. Evaxion to Present Three-Year Efficacy Data for Personalized Cancer Vaccine EVX-01

    Evaxion announced it will present three-year clinical efficacy data for its personalized cancer vaccine candidate, EVX-01, at the ESMO Congress 2026. The data comes from a one-year extension of a Phase 2 trial, during which a subset of patients received EVX-01 as a standalone therapy.

  2. Moderna and Merck Advance mRNA Cancer Vaccine Trials to Phase 3, Explore New Programs

    Moderna and Merck are initiating Phase 3 trials for their mRNA cancer vaccine, mRNA-4157 (V940), in non-small cell lung cancer and other cancer types. Additionally, Moderna is exploring new mRNA programs for autoimmune disease and ovarian cancer.

May 2026 — 2 developments

  1. Moderna and Merck Halt Skin Cancer Vaccine Trial

    Moderna and Merck have discontinued a Phase 2/3 adaptive study of their mRNA cancer vaccine, mRNA-4157 (V940), combined with Keytruda for skin squamous cell cancer. The companies have stopped enrollment and will not proceed to Phase 3 for this indication. Other studies involving mRNA-4157 for melanoma and different tumor types are continuing.

  2. New mRNA Vaccine Tech Explores Non-Immune Cells for Enhanced Cancer Immunotherapy

    Recent research is exploring novel methods to enhance mRNA cancer vaccine effectiveness, including a role for non-immune cells and technology to precisely control mRNA expression. These advancements aim to improve the efficacy of personalized cancer vaccines, while existing data continues to show a 49% reduction in recurrence or death risk for high-risk melanoma patients treated with intisomeran autogene (mRNA-4157) and Keytruda.

April 2026 — 1 developments

  1. Personalized mRNA vaccine for pancreatic cancer shows 6-year survival in early trial

    A personalized mRNA vaccine for pancreatic cancer has shown significant promise in a Phase 1 study, with seven out of eight patients who mounted an immune response remaining alive six years later and exhibiting a lower recurrence rate. This approach tailors the vaccine to individual tumor mutations to train the immune system against cancer cells.

March 2026 — 1 developments

  1. National Cancer Institute funds RNA vaccine research for cancer and melanoma

    A new analysis of federal funding for RNA vaccine research reveals significant investment in areas including cancer and melanoma, indicating a growing focus on RNA technology for therapeutic applications beyond infectious diseases. The National Cancer Institute has awarded grants for solid tumors and melanoma, suggesting a potential for new treatments.

February 2026 — 4 developments

  1. Moderna updates on Phase 2 study of cancer vaccine V940 for lung cancer

    Moderna announced an update on their ongoing Phase 2 study, INTerpath-013, for V940 (mRNA-4157), an mRNA-based cancer vaccine. The vaccine is being tested in combination with Merck's Keytruda and standard chemotherapy as a first-line treatment for patients with metastatic squamous non-small cell lung cancer who have not received prior treatment.

  2. Personalized cancer vaccine intismeran autogene reduces recurrence risk by 49% in KEYNOTE-942 study

    New five-year follow-up data from the KEYNOTE-942/mRNA-4157-P201 study shows that patients treated with the personalized cancer vaccine intismeran autogene combined with Keytruda experienced a 49% lower risk of recurrence or death compared to those receiving Keytruda alone. These results demonstrate sustained protection and reinforce the promise of mRNA cancer vaccines.

January 2026 — 2 developments

  1. Moderna Confirms Ongoing Recruitment for mRNA-4157 Lung Cancer Trial

    Moderna provides an update on its ongoing Phase 3 clinical study for mRNA-4157 in non-small cell lung cancer, confirming the trial is actively recruiting patients. [5]

  2. Moderna and Merck announce 5-year follow-up data for mRNA-4157/V940 in melanoma patients

    Moderna and Merck announce 5-year follow-up data for mRNA-4157/V940, demonstrating sustained protection and a nearly 50% lower risk of recurrence or death in melanoma patients compared to standard therapies. [3, 17, 23]

March 2025 — 1 developments

  1. Personalized mRNA Pancreatic Cancer Vaccine Shows Sustained Immune Activity in Phase 1 Trial

    A personalized mRNA pancreatic cancer vaccine, autogene cevumeran, shows sustained immune activity in a Phase 1 trial, activating tumor-specific immune cells that persisted for up to nearly four years in some patients. [9]

January 2025 — 1 developments

June 2024 — 1 developments

  1. Moderna Presents Positive 3-Year Follow-Up Data for mRNA-4157/Keytruda in Melanoma at ASCO

    Moderna presents 3-year follow-up data for mRNA-4157 (V940) in combination with Keytruda at the American Society of Clinical Oncology (ASCO) meeting, showing sustained improvement in melanoma patients. [2]

May 2024 — 1 developments

  1. NHS England launches Cancer Vaccine Launch Pad; first patient receives personalized mRNA vaccine

    NHS England launches its Cancer Vaccine Launch Pad, with the first patient in England receiving a personalized mRNA vaccine for bowel cancer as part of a clinical trial. [21]

July 2023 — 1 developments

  1. Moderna and Merck Initiate Phase 3 Study for Melanoma Treatment

    Moderna and Merck initiate a pivotal Phase 3 study (V940-001) evaluating mRNA-4157 in combination with pembrolizumab for the adjuvant treatment of patients with resected high-risk stage IIB-IV melanoma. [16]

May 2023 — 1 developments

  1. New Research Suggests mRNA Cancer Vaccines Recruit Unexpected Immune Cells

    New research suggests that mRNA cancer vaccines may recruit unexpected immune cells to mount potent tumor-fighting responses, potentially leading to more effective treatments. This discovery indicates that mRNA cancer vaccines can remain effective even without a certain immune cell, with another cell type stepping in to initiate a strong attack against tumors.

February 2023 — 2 developments

  1. FDA Grants Breakthrough Therapy Designation for mRNA-4157/V940 in High-Risk Melanoma

    The FDA has granted a breakthrough therapy designation to the investigational personalized mRNA cancer vaccine mRNA-4157/V940, when used in combination with pembrolizumab. This designation is for the adjuvant treatment of patients diagnosed with high-risk melanoma following complete resection. The decision was based on previously presented data.

  2. FDA Grants mRNA-4157/V940 Breakthrough Therapy Designation

    The U.S. Food and Drug Administration (FDA) grants mRNA-4157/V940 Breakthrough Therapy designation, accelerating its development and review process. [16]

December 2022 — 1 developments

  1. Moderna and Merck's mRNA cancer vaccine reduces melanoma recurrence by 44% in trial

    Moderna and Merck announce that their personalized mRNA cancer vaccine, mRNA-4157/V940, met its primary efficacy endpoint in a Phase 2b trial for melanoma, demonstrating a 44% reduction in the risk of recurrence or death when combined with Keytruda. [4, 7, 16]

October 2021 — 1 developments

  1. BioNTech Doses First Patient in Phase 2 Trial for Personalized mRNA Cancer Vaccine

    BioNTech doses the first patient in a Phase 2 trial for its personalized mRNA cancer vaccine (BNT122/autogene cevumeran) for high-risk colorectal cancer. [13]

November 2020 — 1 developments

  1. Moderna announces positive interim data from multi-cancer Phase 1 trial for mRNA-4157

    Moderna announces interim data from a multi-cancer Phase 1 trial for mRNA-4157, indicating that the vaccine in combination with Keytruda is well-tolerated. [12]

January 2019 — 1 developments

  1. Moderna and Merck Begin Clinical Trials for mRNA-4157/V940 and Keytruda in Melanoma

    Moderna and Merck jointly initiate clinical trials for mRNA-4157/V940 in combination with Merck's immunotherapy drug Keytruda (pembrolizumab) for resected stage IIIB-IV melanoma. [16]

May 2018 — 1 developments

  1. Moderna and Merck collaborate on personalized mRNA cancer vaccine development

    Moderna and Merck announce a collaboration for the further development of the investigational personalized mRNA cancer vaccine, mRNA-4157/V940. [16]

July 2017 — 1 developments

  1. BioNTech Reports Positive Immune Response in Melanoma Patients from mRNA Vaccine Trial

    BioNTech publishes results from the first clinical trial for an mRNA-based individualized vaccine, demonstrating that all 13 melanoma patients in the study developed an immune response against their specific tumor antigens. [29]