Anbenitamab plus chemotherapy for previously treated HER2-positive gastric or gastroesophageal carcinomas (GC/GEJC): Updated overall survival (OS) analysis of KC-WISE

KC-WISE

Patient / Population Intervention / Exposition Vergleich Endpunkt

In patients with HER2-positive GC/GEJC whose previous therapy containing trastuzumab had failed, anbenitamab plus chemotherapy significantly improved overall survival compared with standard of care.

N

246Patienten

Design

Randomised, placebo-controlled trial in patients with centrally confirmed HER2-positive GC/GEJC who had failed prior therapy containing trastuzumab, comparing anbenitamab vs placebo, each in combination with standard of care (NCT05427383).

Endpunkt

Overall survival, a co-primary endpoint, at a prespecified interim analysis planned for when approximately 150 deaths had occurred. The prespecified final analysis of progression-free survival assessed by independent review committee is also reported.

ErgebnisMedian OS 19.6 months with anbenitamab vs 9.6 months with control (HR 0.39; 95% CI 0.28-0.54; P<0.0001). There were 157 deaths: 66 (52.8%) vs 91 (75.2%). The OS benefit was consistent across all prespecified subgroups. Median IRC-assessed PFS 7.1 vs 2.7 months (HR 0.35; 95% CI 0.26-0.48; P<0.0001), with similar results for investigator-assessed PFS. Grade ≥3 treatment-related adverse events 69.4% vs 47.9%, most commonly neutropenia (33.1% vs 24.8%), leukopenia (27.4% vs 25.6%) and anaemia (24.2% vs 12.4%). Treatment-related deaths occurred in no patients with anbenitamab vs 5 with control.

Xu J, Zhao J, Liu Y, et al. Presented at ESMO Congress 2026, abstract LBA80, 23 October. Not yet published.

Diskussion & Kritik

This placebo-controlled randomised trial shows a large overall survival gain when anbenitamab is added to standard of care after trastuzumab failure, and an independently reviewed PFS benefit supports it. The OS result comes from an interim analysis after 157 deaths, and the abstract does not give the significance boundary used for this interim look or any subgroup data behind the claim of consistency. Grade ≥3 treatment-related adverse events were more frequent with anbenitamab (69.4% vs 47.9%), although no treatment-related deaths occurred in that arm. The abstract does not state the trial phase, the blinding, the allocation ratio or the standard of care regimens used.