Melanoma — high mutational burden makes it the proving ground for personalized neoantigen vaccines, including the mRNA-4157 + pembrolizumab adjuvant program.
by European Society for Medical Oncology edited by Lisa Lock, reviewed by Andrew Zinin This article has been reviewed according to Science X's editorial process and policies. Editors have highlighted the following attributes while ensuring the content's credibility: Adding a pers…
/content/dam/corporate/images/news-and-opinion/news/2026/October/georginalongtimbauer.jpeg Professor Georgina Long to present results of a melanoma vaccine trial that reduces the risk of recurrence or death by 42 percent 2000.1333.2x.jpeg 4000w, 1280.1280.jpeg 1280w, 440.293.2x.j…
Late last week, the drug makers Merck and Cambridge-based Moderna announced that patients who received their melanoma vaccine after surgery were 42 percent less likely to have a recurrence or die within two years than those who did not receive the treatment. And, earlier this mon…
On October 26, 2026, Moderna Inc (NASDAQ: MRNA) CEO Stephane Bancel expressed optimism about the company’s personalized cancer vaccine, intismeran autogene, following phase 3 melanoma trial results that fell short of investor expectations. Bancel emphasized the vaccine’s potentia…
Adding the personalized mRNA-based cancer vaccine intismeran autogene to pembrolizumab significantly reduced the risk for recurrence or death by 42% in patients with high-risk melanoma who had undergone complete surgical resection. At 2 years, recurrence-free survival (RFS) was 8…
A personalized cancer vaccine administered alongside an immunotherapy drug reduced the risk of death or melanoma recurrence by 42%, according to results from a major clinical trial involving more than 1,000 patients. The phase three trial found that the combination of the vaccine…
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Test your knowledge with our new weekday mini crossword Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and aut…
Leaked confidential data. A major stock sell-off. Beneath the chaos surrounding Moderna and Merck's latest data on their personalized cancer vaccine, oncologists see something else: an important milestone in melanoma treatment. The companies on Thursday released detailed results …
A new personalized mRNA vaccine for melanoma is being hailed by some oncologists as a major breakthrough after it reduced the risk of cancer recurrence and death by 42% compared with standard treatment in a late-stage clinical trial. Dr. Robert Vonderheide, director of Penn Medic…
by EMMA KOPPELMAN | The National News Desk (TNND) — A personalized cancer vaccine reduced the risk of melanoma returning or patients dying by 42% when given with a standard immunotherapy drug, according to late-stage trial results released Thursday by drugmakers Moderna and Merck…
The vaccine was custom-brewed for each patient to match their tumor. A first-of-its-kind cancer vaccine is significantly reducing the chances that melanoma patients’ tumors come back, according to results of a major study released Thursday by drugmakers Moderna and Merck. The vac…
Our scientists pursue every aspect of cancer research—from exploring the biology of genes and cells, to developing immune-based treatments, uncovering the causes of metastasis, and more. Our highly-specialized educational programs shape leaders to be at the forefront of cancer ca…
Merck and Moderna report that the personalized mRNA plus mAb cancer therapy cleared its first phase 3 hurdle, cutting recurrence risk beyond pembrolizumab alone. Merck and Moderna announced positive topline results from the phase 3 INTerpath-001 trial evaluating intismeran autoge…
Adding the mRNA-based individualized neoantigen intismeran to pembrolizumab reduced the risk of disease recurrence or death by 42% in melanoma. Adding intismeran autogene, an mRNA-based individualized neoantigen therapy also known as a personalized cancer vaccine, to adjuvant pem…
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When the news arrived in August that what could be the first personalized mRNA cancer vaccine had succeeded in a late-stage clinical trial in melanoma, oncologists and the public alike were exhilarated. And that was before its makers had even disclosed just how well the therapy w…
WASHINGTON (AP) — A first-of-its-kind cancer vaccine is significantly reducing the chances that melanoma patients' tumors come back, according to results of a major study released Thursday by drugmakers Moderna and Merck. The vaccine was custom-brewed for each patient to match th…
Danish clinical-stage techbio Evaxion (Nasdaq: EVAX) has announced new three-year immune and clinical outcome data for personalized cancer vaccine EVX-01 in patients with advanced melanoma, with the news sending the firm’s share up almost 9% to $3.71 in pre-market trading. The da…
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Results from the INTERpath-001 trial of V0940 plus pembrolizumab demonstrated a statistically significant and clinically meaningful improvement in resected melanoma. The primary end point of recurrence-free survival (RFS) and secondary end point of distant metastasis-free surviva…
Evaxion (Nasdaq: EVAX) reported three-year follow-up from its Phase II trial of personalized cancer vaccine EVX-01 in advanced melanoma: all patients maintained the clinical responses observed at two years, with no tumor progression, and received EVX-01 as stand-alone therapy in the third year. Shares rose 5.5% to $2.99 in pre-market trading on the news. For a techbio whose vaccines come off its AI-Immunology platform, extended response durability without progression is the key evidence point that its AI-selected antigens translate into lasting clinical benefit, and stand-alone activity in year three strengthens the case beyond earlier-trial contexts.
Five-year data for intismeran autogene (mRNA-4157/V940) combined with pembrolizumab were presented at the ASCO Annual Meeting in Chicago from the Phase IIb KEYNOTE-942/mRNA-4157-P201 trial, which enrolled 107 patients following melanoma surgery to test whether the combination prevented recurrence better than pembrolizumab alone. The individualized neoantigen therapy is built from each patient's own tumor using mRNA that instructs cells to make tumor proteins, teaching the immune system to distinguish cancer cells from normal ones. Long-term follow-up in the adjuvant melanoma setting is the durability signal underpinning the program's late-stage and commercial case.
Dana-Farber's personalized cancer vaccine NeoVax showed immune activity in an ovarian cancer trial, per the report. The item provides headline-level detail only, but the signal matters because it extends the personalized vaccine approach beyond melanoma, where today's clinical activity is concentrated, into ovarian cancer. Full data disclosure will be needed to judge whether immune activity translates into clinical benefit.
Moderna fell 10% to $214.03 in morning trading as profit taking hit a steep run tied to its personalized cancer vaccine, while BioNTech slipped 2% to $88.59 and Pfizer edged up 0.3% to $29.54; the iShares Biotechnology ETF fell 2% against a roughly flat S&P 500. The pullback follows August news that intismeran autogene plus Keytruda met its primary endpoint in a late-stage melanoma trial, which had driven Moderna's best single-day gain. With a critical trial readout due later this month, the move underscores how concentrated the vaccine thesis has become in near-term catalysts.
Nature has published a phase 1 trial of personalized neoantigen-targeting cancer vaccines in ovarian cancer. Peer-reviewed clinical data in ovarian cancer gives investors a public reference point for the modality in an indication beyond the melanoma-heavy literature that has dominated the field. Worth reading closely for how the personalized vaccine approach performed at the earliest clinical stage in this tumor type.
Personalized mRNA vaccines that train the immune system to hunt a patient’s own tumor mutations are nearing approval, but, as Pharma Voice’s Alexandra Pecci reports, building them may prove harder than discovering them. Merck and Moderna’s melanoma vaccine, intismeran autogene, r…
Evaxion (EVAX) reported two-year phase 2 data for its personalized neoantigen vaccine EVX-01 plus pembrolizumab in advanced melanoma: 12 of 16 patients responded, and 86% of EVX-01 neoantigen targets triggered a tumor-specific immune response. New analyses looking beyond vaccine-specific T-cell responses at effects across the immune system will be presented orally and as posters at SITC 2026 in November. Durable follow-up paired with mechanistic depth is the data package a clinical-stage vaccine developer needs for partnership conversations and next-trial design.
A biorxiv preprint introduces TWISTAR, a platform that deorphanizes single-cell-derived TCRs by screening them against tumor transcriptomes, validating actual TCR engagement so only functionally immunogenic antigens are recovered. Applied to melanoma, breast, and hepatocellular carcinoma patients responding to immune checkpoint blockade, it shows tumor-reactive TCRs recognize targets beyond neoantigens—including peptides from unannotated coding sequences and novel transcripts—many shared across patients and cancer types, with multiple clones converging on a few immune-dominant epitopes. Why it matters: shared, immune-dominant antigens are the prerequisite for off-the-shelf or pan-cancer vaccines, and the finding that the immunogenic landscape is broader than the neoantigen set expands the addressable target space. The work is method-stage and retrospective on ICB responders; no prospective vaccine validation is reported, so watch for independent replication and whether the platform is productized by an antigen-discovery player.
Personalized neoantigen vaccines are moving from early proof to later-stage clinical validation. In melanoma, Moderna and Merck’s mRNA vaccine intismeran, combined with pembrolizumab, met the primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival in a phase 3 trial. In head and neck cancer, Transgene’s personalized vaccine TG4050 induced durable immune responses in a phase 1 trial, but efficacy remains unconfirmed. The contrast matters for investors: melanoma has a positive efficacy signal, while head and neck still requires confirmatory data.
Moderna and Merck reported that their personalized mRNA cancer vaccine mRNA-4157 met its primary endpoint in the Phase 3 INTerpath-001 trial, which enrolled 1,137 high-risk melanoma patients after complete surgical resection. The vaccine combined with Keytruda produced statistically significant improvements in recurrence-free survival and distant metastasis-free survival versus Keytruda monotherapy. The result added more than $50 billion in combined market value to the two companies, with Moderna’s stock rising 177% and adding about $44 billion, and is pushing oncology sequencing and diagnostics into the capital-markets spotlight. It also heightens speculation around Tempus AI’s Personalis bid and rivalry in the sequencing sector.
Volume 10 - 2019 | https://doi.org/10.3389/fimmu.2019.02472 From the Computer to the Clinic: Methods for the Prediction, Validation and Characterization of Tumor Neo-antigens for Applications in Cancer Immunotherapy University of Pennsylvania, United States Volume 10 - 2019 | htt…
The development of cancer immunotherapy is increasingly moving beyond broadly administered immune checkpoint blockade toward strategies designed around the molecular characteristics of an individual patient’s tumor. A major milestone in this direction has now been reported. On Au…
Merck and Moderna announced Wednesday that a personalized mRNA-based cancer vaccine succeeded in a large, late-stage trial among high-risk patients with melanoma. The individualized vaccine, when paired with the existing immunotherapy, Keytruda, is the first and only combination …
Matteo S. Carlino, MD, PhD, FRACP, discussed V940 plus pembrolizumab data, safety, and administration in resected melanoma. CancerNetwork® spoke with Matteo S. Carlino, MD, PhD, FRACP, a medical oncologist at Westmead and Blacktown Hospitals, a faculty member at Melanoma Institut…
All rights reserved, including those for text and data mining, AI training, and similar technologies. The content of this site is intended for health care professionals. Harnessing the immune system through a vaccine to prevent recurrence of metastatic cancer has long been a tant…
Matteo S. Carlino, MD, PhD, FRACP, explains how the individualized neoantigen therapy V940 is designed and delivered in melanoma. Matteo S. Carlino, MD, PhD, FRACP, a medical oncologist at Westmead and Blacktown Hospitals, a faculty member at Melanoma Institute Australia, and a c…
Merck and Moderna announced Wednesday that a personalized mRNA-based cancer vaccine succeeded in a large, late-stage trial among high-risk patients with melanoma. The individualized vaccine, when paired with the existing immunotherapy, Keytruda, is the first and only combination …
Personalized mRNA vaccines are showing promise as a new way to fight cancer, particularly melanoma. The vaccines are designed around mutations unique to a patient’s tumor, helping the immune system target cancer cells. While recent trial results are encouraging, researchers say m…
Moderna and Merck say their personalized mRNA cancer vaccine significantly reduced the risk of melanoma returning or spreading. Get up-to-the-minute news sent straight to your device. Account processing issue - the email address may already exist Must be at least 8 characters, no…
Test your knowledge with our new weekday mini crossword Matthew Herper covers medical innovation — both its promise and its perils. Angus reports on the basic research, clinical science, and drug development that may transform survival and quality of life for patients, as well as…
By The ASCO Post Staff Posted: 8/21/2026 10:29:00 AM Last Updated: 8/21/2026 9:47:23 AM Advertisement Merck and Moderna, Inc. have announced positive topline results from the phase III INTerpath-001 trial (ClinicalTrials.gov identifier NCT05933577) evaluating adjuvant treatment w…
What Is A Neoantigen Cancer Vaccine? The Science Behind Moderna-Merck's Melanoma Breakthrough NDTV Profit
NTxscribe CORE automates mRNA amplification of patient-derived tumor transcriptome, preserving full-length range of each patient’s tumor sequences in a personalized cancer vaccine workflow that is now dosing patients RIO RANCHO, N.M.--(BUSINESS WIRE)--NTx Bio, a leader in next-ge…
Merck and Moderna’s success with a personalized cancer vaccine designed to keep melanoma at bay opens a new avenue of treatment that doctors hope will work against many types of tumors. Unlike chemotherapy, which kills both healthy and cancerous cells, or immunotherapy, which re…
TOLEDO, Ohio (WTVG) - A new cancer vaccine is delivering hope in the fight against melanoma, the deadliest type of skin cancer. The vaccine is still undergoing trials, but results suggest it can stop the disease from coming back or spreading. The American Cancer Society says skin…
Subscribe to Smithsonian magazine and get a FREE tote. A personalized cancer vaccine, used in combination with an existing treatment, helped prevent the return and spread of melanoma in a late-stage clinical trial, Moderna and Merck, the companies developing the drug, announced t…
The experimental mRNA vaccine successfully cleared phase 3 clinical trials, the last step necessary before it can be approved by the FDA. An experimental mRNA cancer vaccine prevented the return and spread of melanoma, the deadliest form of skin cancer, in a large clinical trial,…
Merck and Moderna report positive phase III results for intismeran in melanoma, as The Medicine Maker revisits how cancer vaccines work and the challenges still facing the field A personalized mRNA cancer vaccine has delivered the first positive phase III readout for an individua…
Loizos Loizou, Head of Cyprus International Action Plan for Children with Cancer at ELPIDA Foundation for Children with Cancer, shared on LinkedIn: High-Risk Melanoma, Important New Hope: Personalized Therapeutic mRNA Vaccine. Melanoma is a particularly aggressive and dangerous s…
Intismeran autogene, an individualized neoantigen therapy, makes history on Wall Street as well as within the industry following its first positive Phase III data in a form of melanoma Investors of Merck & Co. (NYSE: MRK) and Moderna (Nasdaq: MRNA) were the most obvious—but not t…
Stéphane Bancel, Founding CEO at Moderna, shared an update from Moderna, on LinkedIn, adding: In 2020, mRNA helped change what was possible in infectious disease, as our teams worked to deliver a COVID-19 vaccine at unprecedented speed, in less than a year. Today, we announced th…
The combination of the personalized vaccine and Keytruda has been reported to outperform Keytruda alone in preventing melanoma recurrence. This marks the first positive Phase 3 trial for a personalized cancer vaccine, signaling a potential shift in adjuvant treatment standards for high-risk patients following surgical resection.
Merck and Moderna announced that their personalized mRNA vaccine regimen successfully passed a large Phase 3 trial, reducing the risk of melanoma return or spread. While the FDA has not yet approved the treatment, the companies note it is the first combination regimen to demonstrate success in potentially extending lifespans for high-risk resected melanoma patients.
In the INTerpath-001 trial, 1,137 patients with resected stage IIB through IV melanoma were randomized to receive Keytruda plus the personalized vaccine or Keytruda plus placebo. The combination arm showed significantly better recurrence-free and distant metastasis-free survival, marking the first positive Phase 3 result for an mRNA-based personalized cancer therapy.
Moderna and Merck announced that intismeran autogene plus Keytruda met its primary endpoints of improving RFS and DMFS in a Phase 3 study of 1,137 high-risk melanoma patients. The personalized vaccine is designed to teach the immune system to target tumor-specific mutations, offering a mechanism distinct from chemotherapy or broad immunostimulation.
Moderna and Merck announced positive late-stage trial results for a personalized mRNA therapy combined with Keytruda in melanoma patients who had their cancer surgically removed. The companies plan to share full data at upcoming medical meetings, noting that the treatment aims to increase the possibility of cure by intervening early in the disease course.
The INTerpath-001 trial evaluated adjuvant intismeran autogene, an mRNA-based neoantigen therapy tailored to each patient's unique mutational signature, alongside pembrolizumab. Each dose contains synthetic mRNA coding for up to 34 neoantigens derived from the patient's tumor, aiming to activate a targeted anti-tumor immune response in patients with completely resected stage IIB–IV melanoma.
MSD and Moderna reported the first positive Phase III readout for an individualized neoantigen therapy (INT) combined with an mRNA-based cancer therapy. The data shows intismeran autogene plus pembrolizumab can facilitate longer cancer-free survival in completely resected stage IIB-IV melanoma compared to Keytruda alone.
Merck CEO Rob Davis highlighted the positive Phase 3 topline results for intismeran autogene plus Keytruda in the adjuvant setting for resected stage IIB-IV melanoma. He described the achievement as a defining moment for cancer research, validating the joint effort between Merck and Moderna scientists in developing this individualized neoantigen therapy.
Moderna and Merck announced that their experimental personalized vaccine, combined with Keytruda, kept melanoma from spreading or returning longer than Keytruda alone in a trial of 1,137 patients. Experts describe the approach as highly promising for delaying recurrence and extending survival, with implications potentially reaching beyond melanoma to other cancer types.
A personalized vaccine paired with Keytruda has shown strong results in reducing melanoma recurrence and spread compared to Keytruda alone in a late-stage trial. The announcement highlights the potential of this combination regimen to improve outcomes for patients with high-risk disease following surgical resection.
ABC News reports on the positive trial results for a personalized cancer vaccine in melanoma. The coverage underscores the significance of the Moderna and Merck partnership in delivering a treatment that targets specific tumor mutations to prevent disease recurrence.
Moderna President Stephen Hoge stated that if regulators approve the personalized cancer vaccine, thousands of patients with high-risk resected melanoma could benefit as soon as next year. The announcement comes as Moderna and Merck seek to establish this mRNA-based neoantigen therapy as a standard adjuvant treatment.
Moderna CEO Stéphane Bancel described the success of intismeran autogene as turning an aspirational vision into reality. The customized treatment uses patient tumor tissue to train the immune system, targeting high-risk melanoma stages that were surgically removed but carried a high chance of recurrence.
Moderna and Merck’s personalized mRNA vaccine met its main goal in a late-stage melanoma trial when combined with Keytruda. The treatment significantly reduced the risk of high-risk skin cancer returning compared to standard therapy, validating the neoantigen approach in a pivotal setting.
The Phase 3 trial of intismeran autogene involved 1,137 patients with high-risk melanoma whose tumors had been surgically removed. Patients receiving the vaccine plus Keytruda met the primary goal of reducing cancer return and spread compared to Keytruda alone, though detailed statistical data has not yet been released.
Success in this large melanoma trial raises hopes that personalized neoantigen vaccines could be applied to other cancer types. Unlike broad immunotherapies, the vaccine is custom-built for each patient by instructing the immune system to attack mutations unique to their specific tumor.
This week’s BioPharm Brief covers positive phase 3 melanoma results for Merck and Moderna’s individualized neoantigen therapy, a personalized cancer vaccine manufacturing platform entering clinical use, and a new brain-penetrant antibody approach for glioblastoma. Welcome to The …
Merck and Moderna announced that the vaccine-drug combo extended the time before cancer returned in high-risk patients, though specific duration metrics were not disclosed. Interim data from an earlier ASCO presentation indicated a halving of melanoma return risk after five years.
The regimen is the first and only combination to demonstrate success in potentially extending melanoma lifespans in Phase 3. Previous Phase 2b data showed a 49% reduction in return and 59% reduction in metastasis, with regulatory review pending full data submission to the FDA.
Moderna’s personalized cancer vaccine has scored a late-stage win, validating the commercial and clinical viability of neoantigen targeting. This success establishes a new standard for adjuvant treatment in high-risk melanoma patients.
Moderna’s personalized cancer vaccine has scored a late-stage win, confirming the efficacy of its mRNA platform in preventing melanoma recurrence. This milestone underscores the potential for neoantigen vaccines to become a cornerstone of oncology treatment.
Personalized cancer vaccine shows positive late-stage trial results, reinforcing the strategic value of mRNA-based immunotherapies. The success in melanoma provides a proof-of-concept for broader application across other tumor types.
Personalized cancer vaccine shows positive late-stage trial results, marking a significant advancement in adjuvant melanoma therapy. The outcome highlights the industry's shift toward highly individualized treatments that target specific tumor mutations.
Merck and Moderna’s success opens a new avenue of treatment that doctors hope will work against many types of tumors. Unlike chemotherapy, the personalized vaccine trains the immune system to specifically target mutations found only on a person's tumor, with thousands of melanoma patients expected to benefit upon approval.
Moderna and Merck announced positive Phase 3 results for their jointly developed personalized mRNA cancer vaccine in high-risk melanoma patients, marking a historic milestone for mRNA technology in oncology. Combining the vaccine with Keytruda significantly delayed cancer recurre…
According to the National Cancer Institute, in 2023 more than 1.5 million people in the US suffered from melanoma Merck and Moderna’s experimental personalized cancer vaccine has shown promising success in Melanoma’s first-ever late-stage trial. The landmark success in the trial …
A Phase III trial of intismeran autogene, the mRNA-based individualized neoantigen therapy co-developed by Merck (NYSE: MRK) and Moderna (Nasdaq: MRNA), has met both its primary and a key secondary endpoint in patients with completely resected stage IIB-IV melanoma, the companies…
Moderna is headquartered at 325 Binney Street in Cambridge. Moderna Inc.’s personalized cancer vaccine is now one big step closer to seeking approval. Merck and Moderna said that new Phase 3 data showed intismeran autogene combined with Keytruda reduced melanoma recurrence and sp…
Moderna and Merck's jointly developed personalized mRNA cancer vaccine has succeeded in suppressing cancer recurrence and metastasis in high-risk melanoma patients in a late-stage clinical trial. This marks the first time a personalized mRNA cancer therapeutic has met its primary…
Merck and Moderna announced positive initial results from their first late-stage trial of an experimental personalized cancer vaccine combined with Merck's immunotherapy Keytruda. The phase three trial involving over 1,100 melanoma patients showed the combo significantly extended…
NTx Bio Powers Baylor College of Medicine's Manufacturing of a Personalized Cancer Vaccine in Diakonos Oncology's Phase 1 Refractory Melanoma Trial Business Wire
Researchers developed SPEAR gRNAs to harness endogenous ADAR1 for precise A-to-I RNA editing, creating immunogenic neoepitopes termed 'editopes.' In a melanoma model using the MART-1 antigen, this approach restored T-cell recognition and enabled tumor control in vivo. The team also established a computational pipeline to identify candidate tumor-selective neoepitopes across multiple cancer types.
Follow-up data from the phase 2b KEYNOTE-942 trial shows that BioNTech’s mRNA-4157 combined with pembrolizumab reduced the risk of recurrence or death by 49% in high-risk stage III/IV melanoma patients compared to pembrolizumab alone. The combination also cut the risk of distant metastases or death by 62% at a median follow-up of three years. These results support the clinical benefit of personalized neoantigen mRNA vaccines in adjuvant settings.
The data stems from a one-year extension of the phase 2 trial evaluating EVX-01 in patients with advanced melanoma (skin cancer). In the third year, patients received EVX-01 as stand-alone therapy, meaning the data will offer insight into the vaccine’s effect also when not admini…
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Primary tumors and their sentinel lymph nodes are functionally linked sites of anti-tumor immunity, yet how T cell receptor (TCR) repertoires are organized across these compartments remains incompletely understood. We thus performed TCR{beta} sequencing on paired primary melanoma…