HOOKIPA reports 53% ORR in CPS≥20 subgroup from Phase2 HB-200 + pembro trial at ASCO

HOOKIPA Pharma Inc.

Among 35 evaluable first-line HPV16+ HNSCC patients, ORR 37%, CR 11%, DCR 69% per RECIST 1.1.
In CPS≥20 subgroup (N=17, registrational target): ORR 53%, CR 18%, DCR 82%; PFS 16.3 mo, OS rate 88% at 9 mo.
HB-200 + pembrolizumab well-tolerated; Grade≥3 TRAEs in 15%, no treatment-related deaths.
Company plans to begin pivotal Phase 2/3 trial in Q4 2024 with FDA alignment on path to accelerated approval.
Data presented as oral abstract at ASCO 2024; median follow-up for CPS≥20 subgroup was 8.4 months.

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