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Study indicates clear route to market despite not meeting the primary endpoint of 6 months’ overall response rate (ORR) in the entire population

In a predefined subgroup of patients there was a doubling of ORR (51.9% vs 26.7% for placebo) and improved overall survival which sets the stage for a confirmatory Phase 3 trial

Oegstgeest, 12 December 2023 — ISA today announced positive anti-tumor response data with ISA101b, an HPV16 directed therapeutic cancer vaccine given in combination with Libtayo®, an anti-PD1 checkpoint inhibitor (CPI).  The data were generated in the OpcemISA trial, a large scale randomized double blind study that is ongoing