Evaxion will present three-year Phase 2 data for its AI-designed personalized cancer vaccine EVX-01 at ESMO 2026, highlighting durable immune responses and long-term disease control in advanced melanoma.
Written By: Meghana Jinka, PharmD
Reviewed By: Pharmacally Editorial Team
Evaxion A/S will present three-year follow-up data from its Phase 2 clinical trial of the personalized cancer vaccine EVX-01 at the European Society for Medical Oncology (ESMO) Congress 2026, providing new insights into the durability of immune responses and long-term disease control in patients with advanced melanoma.
The data come from a one-year extension of the ongoing Phase 2 study, in which a subset of patients received EVX-01 as stand-alone therapy during the third year after initially receiving the vaccine in combination with Merck’s anti-PD-1 checkpoint inhibitor KEYTRUDA® (pembrolizumab). The findings may help clarify the vaccine’s long-term therapeutic activity independent of checkpoint inhibition while further evaluating the persistence of EVX-01-induced antitumor immunity.
Personalized Vaccine Targets Patient-Specific Tumor Neoantigens
EVX-01 is Evaxion’s lead clinical-stage asset and is generated individually for each patient using the company’s AI-Immunology™ platform. The peptide-based vaccine targets patient-specific tumor neoantigens identified from each individual’s cancer biology and immune profile, with the goal of stimulating a targeted T-cell response against malignant cells.
Advanced melanoma remains one of the most aggressive forms of skin cancer despite major advances in immunotherapy. Although immune checkpoint inhibitors have improved survival for many patients, a substantial proportion either fail to respond or eventually develop disease progression, highlighting the need for strategies that strengthen durable antitumor immunity.
Three-Year Extension Evaluates EVX-01 Without Checkpoint Inhibition
The Phase 2 trial enrolled patients with advanced melanoma receiving first-line treatment. During the initial two years, participants were treated with EVX-01 in combination with pembrolizumab. In the third year, selected patients continued with EVX-01 alone, allowing investigators to assess whether immune responses and disease control persist after discontinuation of anti-PD-1 therapy.
The three-year findings will be presented as a poster during the ESMO Congress 2026 in Madrid on October 24. The presentation, titled “EVX-01, a personalized cancer vaccine, induces sustained T-cell responses and durable disease control in advanced melanoma after three-year of follow-up” (Poster 2006P), will be delivered by Dr. Muhammad Adnan Khattak of One Clinical Research, Hollywood Private Hospital, and Edith Cowan University in Australia.
Earlier Results Demonstrated Durable Clinical Responses
The upcoming presentation builds on encouraging two-year Phase 2 results (NCT05309421) reported previously.
Among 16 treated patients, EVX-01 combined with pembrolizumab produced an objective response rate (ORR) of 75%, with 12 patients achieving objective responses, including four complete responses. Durable clinical benefit was maintained in 92% of responding patients after two years, and no relapses were reported during follow-up.
More than half of participants experienced deepening clinical responses over time, progressing from stable disease or partial response to either partial or complete response. Tumor shrinkage was observed in 15 of the 16 enrolled patients.
Immunological analyses also showed vaccine-induced immune activation across the study population. EVX-01 generated measurable immune responses in all treated patients, while 86% of targeted neoantigens elicited strong antigen-specific T-cell responses.
ESMO Presentation May Inform Future Development Strategy
Chief Scientific Officer and Chief Operating Officer Birgitte Rønø said the ESMO presentation will provide an opportunity to discuss the long-term clinical findings with investigators and potential partners as late-stage evidence continues to emerge across the personalized cancer vaccine field.
The three-year dataset may help define whether individualized neoantigen vaccines can maintain durable immune surveillance after checkpoint inhibitor therapy ends, an important question as personalized cancer vaccines continue advancing through clinical development.
EVX-01 is currently being investigated as a potential first-line treatment for multiple advanced solid tumors, with the long-term melanoma data expected to further guide its future clinical and strategic development.
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About the Writer
Meghana Jinka (LinkedIn) is a Pharm.D graduate with a strong interest in clinical pharmacy, clinical research, pharmacovigilance, and medical writing. She has developed expertise in evaluating scientific literature, interpreting clinical data, and communicating complex medical information in a clear and accessible manner. Through clinical training, patient counseling, and healthcare awareness activities, she has gained practical experience in evidence-based medicine and patient-centered care. Passionate about healthcare communication, Meghana is committed to developing accurate, engaging, and evidence-based healthcare documents that support healthcare professionals and the wider community.