Cadonilimab (AK104) PD-1/CTLA-4 bispecific + gem/nab-paclitaxel posts 33.9% ORR and 13.8-mo mOS in 1L advanced PDAC

Cadonilimab is a PD-1/CTLA-4 bispecific antibody (AK104) evaluated with gemcitabine + nab-paclitaxel (AG) in the Phase 2, multicenter, open-label COMPASSION-26 study (NCT05859750) as first-line therapy for unresectable locally advanced or metastatic PDAC (n=59; 56 evaluable; cutoff Oct 20, 2025). ORR was 33.9% (19/56) with DCR 96.4% (54/56); overall median PFS was 8.5 months and median OS 13.8 months, with strong splitting by disease status (locally advanced: PFS 11.1 mo, OS 23.4 mo; metastatic: PFS 7.2 mo, OS 10.5 mo). Relative to AG alone in metastatic PDAC (MPACT: mPFS ~5.5 mo, mOS ~8.5 mo), the metastatic-cohort outcomes here look directionally better for both PFS and OS, while safety appears dominated by expected chemo-type cytopenias (TRAEs 100%; neutrophil decrease 96.6%, anemia 89.8%, WBC decrease 84.7%, platelets decrease 76.3) plus immune-style rash/pruritus and transaminase elevations; grade 3+ rates and discontinuations were not reported, limiting true tolerability comparisons.