IO Biotech has concluded subject enrolment in the Phase III IOB-013/KN-D18 clinical trial for IO102-IO103 combination therapy to treat advanced melanoma. 

Sponsored by IO Biotech, the randomised, open-label pivotal trial will analyse IO102-IO103 along with pembrolizumab compared to pembrolizumab alone for priorly untreated, unresectable or metastatic (advanced) melanoma.

The trial has so far enrolled a total of 380 subjects at study sites across Australia, the US, Europe, Israel, South Africa and Turkey.

The company will carry out a per-protocol interim assessment of the study mid-next year.

Progression-free survival is the trial’s primary endpoint with analysis slated to be carried out in the second half of 2025. 

An investigational cancer vaccine, IO102-IO103 acts on the immunosuppressive mechanisms.

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MSD is providing its anti-PD-1 therapy pembrolizumab required for the trial.

IO Biotech president and CEO Mai-Britt Zocca said: “The Phase I/II data of IO102-IO103 in combination with a PD-1 inhibitor in patients with first-line advanced melanoma demonstrated approximately double the effect than would have been expected with PD-1 inhibitor monotherapy in this patient population – with 80% of patients achieving a response, 50% of patients achieving a complete response, and no additional systemic toxicity than that typically seen with a PD-1 inhibitor alone. 

“Completion of enrolment in this pivotal Phase III trial marks a significant milestone for our company and is a testament to the enthusiasm for this study among our investigators and the patient community.”