Evaxion Reports Sustained Three-Year Responses with EVX-01 in Advanced Melanoma

20 October 2026 | Tuesday | News

Phase 2 follow-up showed no tumour progression among patients assessed at three years, building on earlier results showing a 75% objective response rate and 25% complete response rate.
Image Source: Public Domain

Image Source: Public Domain

  • Three-year data from the EVX-01 phase 2 trial in patients with advanced melanoma to be presented at the ESMO 2026 Congress
  • Data supplements unprecedented two-year data from the trial including a 75% Objective Response Rate with 25% of patients obtaining a complete response
  • This new clinical and new immune data will be presented at a poster session on October 24, 2026, followed by a webinar on October 29, 2026, providing further insights into the findings

Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel immunotherapies with its pioneering AI-Immunology™ platform, announces new three-year clinical outcome data for personalized cancer vaccine EVX-01 in patients with advanced melanoma.

All patients at three-year follow-up in the phase 2 trial maintained the clinical responses observed at two-year follow-up, with no tumor progression observed. In the third year of treatment, patients received EVX-01 as stand-alone therapy. The data, coupled with new immune data, will be presented in a poster session at the European Society for Medical Oncology (ESMO) Congress 2026 to be held in Madrid, Spain, from October 23-27, 2026.

The new findings supplement the unprecedented two-year data presented at ESMO in 2025, showing a 75% Objective Response Rate with 25% of patients obtaining a complete response.

“We are highly excited by the new data reflecting a long durability of clinical responses in this hard-to-treat patient population. This is another strong confirmation of the clinical potential of personalized cancer vaccines in general, and EVX-01 in particular, which we are looking forward to sharing and discussing at the important ESMO Congress. The new data further adds to EVX-01’s strong data package as a good foundation for potential partnership discussions,” says Birgitte Rønø, CSO and COO of Evaxion.

Building on convincing two-year results
In addition to promising response rates, the two-year data from the trial also showed a durable clinical benefit, with 92% of patients still responding at two years of follow-up and no relapses observed.

54% of patients had a deepened response following initiation of EVX-01 treatment, improving from stable disease or partial response to partial or complete response. Tumor reduction (target lesions) was observed in 15 out of the 16 patients enrolled in the trial.

EVX-01 induced an immune response in all patients, with 86% of the vaccine neoantigens generating potent specific T-cell responses as measured at the two-year follow-up.

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