Evaxion A/S said six participants in an extension of its phase 2 melanoma study still showed clinical responses at a three-year follow-up, extending the reported follow-up for its personalized vaccine. The company said no tumor progression was observed in the group.
The extension involved six of the 12 patients Evaxion had counted as responders at the two-year mark. The company reported objective responses in 12 of the 16 original participants, including four complete responses, and said 11 of the 12 responders were still responding at month 24. The third-year result therefore covers half of the earlier responder group, rather than all 16 trial participants. Evaxion’s Oct. 19 announcement did not say why the other six responders did not enter the extension.
EVX-01 is tailored to each patient’s tumor. Pembrolizumab treatment began with a 12-week lead-in before EVX-01 was added. The treatments were then used together during the initial two-year period; the six extension participants received EVX-01 alone in year three.
The phase 2 study was open label and had a single treatment arm, with no comparison group. That design cannot show how much EVX-01 contributed to the reported responses. Evaxion also said it did not formally analyze the primary endpoint after enrollment fell below the original protocol target. Progression-free and overall survival had not been reported at the two-year data cutoff.
Chief Scientific Officer and Chief Operating Officer Birgitte Rønø said the new findings add to EVX-01’s broader data package, which she called “a good foundation for potential partnership discussions.”
Evaxion plans to present fuller three-year clinical and immune data during a Saturday, Oct. 24, poster session in Madrid for the European Society for Medical Oncology (ESMO) Congress. The company has scheduled a webinar for Oct. 29.
