Personalized mRNA Cancer Vaccines
Moderna and Merck discontinued a Phase 2/3 adaptive study of their mRNA cancer vaccine, mRNA-4157 (V940), combined with Keytruda for skin squamous cell cancer on May 8, 2026, stopping enrollment and not proceeding to Phase 3 for this indication. As of May 8, 2026: Other studies involving mRNA-4157 for melanoma and different tumor types are continuing. This decision follows promising five-year follow-up data released on January 21, 2026, showing mRNA-4157/V940 demonstrated a nearly 50% lower risk of recurrence or death in melanoma patients compared to standard therapies. Additionally, a personalized mRNA vaccine for pancreatic cancer showed significant promise in a Phase 1 study, with seven out of eight patients who mounted an immune response remaining alive six years later as of April 27, 2026. Australia is also launching the world-first PaedNEO-VAX clinical trial to treat children with advanced or treatment-resistant brain tumors using personalized mRNA vaccines, as announced on February 2, 2026.
Timeline
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May 2026 — 2 developments
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.
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.
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.
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
A personalized mRNA vaccine for pancreatic cancer has shown significant promise in a Phase 1 study, …
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
A new analysis of federal funding for RNA vaccine research reveals significant investment in areas i…
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
Moderna announced an update on their ongoing Phase 2 study, INTerpath-013, for V940 (mRNA-4157), an mRNA-based cancer vaccine.
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.
New five-year follow-up data from the KEYNOTE-942/mRNA-4157-P201 study shows that patients treated w…
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.
Australia is launching the world-first PaedNEO-VAX clinical trial to treat children with advanced or…
Australia is launching the world-first PaedNEO-VAX clinical trial to treat children with advanced or treatment-resistant brain tumors using personalized mRNA vaccines, which will be customized based on each child's unique cancer markers.
Newly formed French biotech Kahimmune Therapeutics has secured an exclusive license for a 'dark-geno…
Newly formed French biotech Kahimmune Therapeutics has secured an exclusive license for a 'dark-genome' cancer vaccine platform, aiming to develop shared mRNA cancer vaccines initially for colorectal and pancreatic cancer.
January 2026 — 2 developments
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.
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]
Moderna and Merck announce 5-year follow-up data for mRNA-4157/V940, demonstrating sustained protect…
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
A personalized mRNA pancreatic cancer vaccine, autogene cevumeran, shows sustained immune activity i…
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
Russia announced its first mRNA-based cancer vaccine, which is expected to be available by early 202…
Russia announced its first mRNA-based cancer vaccine, which is expected to be available by early 2025 and aims to revolutionize cancer treatment by triggering an immune response against cancer cells.
June 2024 — 1 developments
Moderna presents 3-year follow-up data for mRNA-4157 (V940) in combination with Keytruda at the Amer…
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
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.
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
Moderna and Merck initiate a pivotal Phase 3 study (V940-001) evaluating mRNA-4157 in combination wi…
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]
February 2023 — 2 developments
The FDA has granted a breakthrough therapy designation to the investigational personalized mRNA cancer vaccine mRNA-4157/V940, when used in combination with pembrolizumab.
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.
The U.S. Food and Drug Administration (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
Moderna and Merck announce that their personalized mRNA cancer vaccine, mRNA-4157/V940, met its prim…
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
BioNTech doses the first patient in a Phase 2 trial for its personalized mRNA cancer vaccine (BNT122/autogene cevumeran) for high-risk colorectal cancer.
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
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.
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
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.
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
Moderna and Merck announce a collaboration for the further development of the investigational personalized mRNA cancer vaccine, mRNA-4157/V940.
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
BioNTech publishes results from the first clinical trial for an mRNA-based individualized vaccine, d…
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]