On June 14, 2023 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win technology platform, reported that it has randomized 225 patients in its global Phase 3 clinical trial for IO102-IO103, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced melanoma (Press release, IO Biotech, JUN 14, 2023, View Source [SID1234632700]). This clinical milestone is significant as the Phase 3 trial protocol calls for an interim analysis of overall response rate one year after 225 patients have been enrolled. Data obtained from this interim analysis, if positive, could allow for submission of a Biologics License Application for an accelerated approval in the United States.
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Additionally, the company announced that it is increasing the number of patients to be enrolled in the Phase 3 trial to 380 patients, which could potentially accelerate the time to reach the primary end point of progression free survival. If the data are supportive, the PFS endpoint would serve as the basis for submitting marketing applications on a global basis.
"I am very proud to announce today that we have hit this critical enrollment milestone in our global Phase 3 clinical trial as planned," said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. "The enthusiasm for this trial in cancer care centers in Europe, Australia, South Africa, Israel, and the United States is a testament to the need for improved outcomes for patients with advanced melanoma. With the momentum of enrollment building in this trial, we are taking the opportunity to increase the target for full enrollment by 80 patients, which will potentially accelerate the timeline to the primary endpoint of PFS. Even with this increase in target enrollment to 380 patients, we continue to expect to reach full enrollment 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."
Dr. Zocca continued, "Our full team continues to work diligently to develop novel vaccines that have the potential to significantly improve the current treatment paradigm for people with cancer. Should the interim analysis for this Phase 3 trial be positive, we have the potential to have our first vaccine candidate approved and available for patients in 2025 – this is an exciting time in the evolution of IO Biotech."
About IO102-IO103
IO102-IO103 is an investigational immune-modulating cancer vaccine designed to target the immunosuppressive mechanisms mediated by the key immunosuppressive proteins indoleamine 2,3-dioxygenase (IDO) and PD-L1.
About the IOB-013/KN-D18 Phase 3 Clinical Trial
IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma, being conducted in collaboration with Merck. Target enrollment is 380 patients from centers spread across the United States, Europe, Australia, Israel and South Africa. Biomarker analyses will also be conducted. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.