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IO Biotech Updates on Pivotal Phase 3 Trial of IO102-IO103 in Combination with KEYTRUDA® (pembrolizumab) as a First-Line Treatment for Patients with Advanced Melanoma
IO Biotech (Nasdaq: IOBT) announced that the Independent Data Monitoring Committee (IDMC) recommended the continuation of its pivotal Phase 3 trial for IO102-IO103, a novel therapeutic cancer vaccine, in combination with KEYTRUDA® (pembrolizumab) for advanced melanoma. Key points:
1. No new safety signals observed
2. Primary endpoint of progression-free survival (PFS) projected for first half of 2025
3. Trial powered at 89% to detect a 35% reduction in event risk
4. 407 patients randomized
5. Interim analysis did not meet criteria for superiority in overall response rate (ORR)
6. Company remains optimistic based on Phase 1/2 results showing 25.5 months median PFS
IO Biotech also reported promising preliminary data from a Phase 2 basket trial in NSCLC and SCCHN, with upcoming presentations at medical conferences.
1. No new safety signals observed
2. Primary endpoint of progression-free survival (PFS) projected for first half of 2025
3. Trial powered at 89% to detect a 35% reduction in event risk
4. 407 patients randomized
5. Interim analysis did not meet criteria for superiority in overall response rate (ORR)
6. Company remains optimistic based on Phase 1/2 results showing 25.5 months median PFS
IO Biotech also reported promising preliminary data from a Phase 2 basket trial in NSCLC and SCCHN, with upcoming presentations at medical conferences.
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