Onco-Summaries: Daily Oncology Updates at a Glance

11/08/2025

IO Biotech's Cylembio + pembrolizumab demonstrated clinical improvement in PFS as a first-line treatment of Melanoma, but statistical significance was narrowly missed (Ref)

IO Biotech announced topline results from the pivotal Phase 3 IOB-013 trial of Cylembio (imsapepimut and etimupepimut, adjuvanted; IDO and PD-L1 vaccine) + pembrolizumab vs pembrolizumab alone as a first-line treatment of advanced melanoma.

• The combo demonstrated clinical improvement in PFS vs pembrolizumab alone, but statistical significance was narrowly missed on the primary endpoint (HR 0.77; p=0.056; threshold for significance p≤0.045), with mPFS of 19.4 vs 11.0 mos

  
  

• A profound effect was observed in PD-L1 negative subgroup (HR 0.54; nominal p=0.006), with mPFS of 16.6 vs 3.0 mos