IO Biotech Announces Promising Results in Phase 3 Trial of Cylembio Plus KEYTRUDA for Advanced Melanoma, Plans FDA Meeting
IO Biotech Inc. has announced clinical improvement in progression-free survival demonstrated in a pivotal Phase 3 trial of Cylembio® combined with KEYTRUDA® (Pembrolizumab) for the treatment of first-line advanced melanoma. The results showed that patients treated with the combination therapy achieved an improvement in progression-free survival compared to those treated with pembrolizumab monotherapy, with a hazard ratio of 0.77 and a median progression-free survival of 19.4 months versus 11.0 months. However, the study's primary endpoint narrowly missed the statistical significance threshold. IO Biotech plans to discuss the data with the United States Food and Drug Administration this fall to determine next steps for submission of a Biologics License Application. The company also plans to present more detailed results from the IOB-013 study at a future medical meeting.
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