IO Biotech has received recommendation from the Independent Data Monitoring Committee (IDMC) to continue the Phase III IOB-013/KN-D18 clinical trial of the investigational therapeutic vaccine IO102-IO103, in combination with KEYTRUDA (pembrolizumab) for advanced melanoma.
This development follows a per-protocol interim analysis review of the trial, which is assessing the vaccine’s efficacy as a first-line treatment for patients with advanced melanoma.
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The open-label and randomised trial is designed to compare the combination of IO102-IO103 with pembrolizumab to pembrolizumab alone in previously untreated, unresectable or metastatic melanoma patients.
More than 100 centres across Europe, the US, Australia, Turkey, South Africa and Israel have enrolled a total of 407 patients.
The interim analysis occurred one year after 225 subjects were randomised, setting a high statistical bar for declaring the superiority of objective response rate (ORR), which the data did not meet at this stage.
A recommendation from the IDMC came after reviewing safety and efficacy data, noting that no new safety signals were observed.
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By GlobalDataThe primary endpoint of progression-free survival (PFS) is anticipated to be reached in the first half of next year.
IO Biotech president and CEO Mai-Britt Zocca said: “To date, none of the approved immunotherapeutic combinations for the treatment of advanced melanoma demonstrated statistical significance in ORR in large Phase III trials; nevertheless, these trials achieved statistical significance on PFS.
“Based on the 25.5 months median PFS we observed in the Phase I/II trial of IO102-IO103 in combination with a PD-1 inhibitor in advanced melanoma, with no added significant systemic toxicity than that typically seen with anti-PD-1 monotherapy, we remain optimistic about meeting the primary endpoint of PFS, projected to occur in the first half of 2025.”
In November last year, the company concluded subject enrolment in the Phase III IOB-013/KN-D18 trial for IO102-IO103 combination therapy to treat advanced melanoma.
