IO Biotech has achieved recruitment milestonewith the randomisation of 225 patients in its Phase III clinical trial of IO102-IO103 combined with Merck’s KEYTRUDA (pembrolizumab) for treating advanced melanoma.
The open label IOB-013/KN-D18 study protocol calls for an interim analysis of overall response rate (ORR) one year after 225 patients have been randomised.
It is carried out in collaboration with Merck which is supplying pembrolizumab, an anti-PD-1 therapy, for the trial.
The Phase III study will also conduct biomarker analyses.
IO Biotech president and CEO Mai-Britt Zocca said: “The enthusiasm for this trial in cancer care centres in Europe, Australia, South Africa, Israel, and the US is a testament to the need for improved outcomes for patients with advanced melanoma.
“With the momentum of enrolment building in this trial, we are taking the opportunity to increase the target for full enrolment by 80 patients, which will potentially accelerate the timeline to the primary endpoint of progression free survival.
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“Even with this increase in target enrolment to 380 patients, we continue to expect to reach full enrolment in this trial by the end of this year and we continue to expect our cash to support our activities through the third quarter of 2024.”
IO102-IO103, an investigational immune-modulating cancer vaccine, targets the immunosuppressive mechanisms mediated by proteins indoleamine 2,3-dioxygenase and PD-L1.
If the interim analysis for the Phase III trial be positive, IO Biotech will further submit a biologics license application of the cancer vaccine for an accelerated approval in the US. The vaccine is expected to be available to the patients by 2025.