BeyondSpring highlights confirmatory Phase 3 DUBLIN-4 trial plan for plinabulin in post-ICI NSCLC
BYSI•
BYSI•DUBLIN-3 Phase 3 met the overall survival endpoint; OS HR was 0.82, with p=0.0399 in EGFR wild-type 2L/3L NSCLC.
In the non-squamous subgroup, median OS was 11.37 versus 8.81 months; HR was 0.72, with p=0.0078. Grade 4 neutropenia was 5.13% versus 33.58%.
BeyondSpring investor presentation highlighted plinabulin as a late-stage oncology asset targeting post-ICI, driver-negative non-squamous NSCLC.
DUBLIN-4 confirmatory Phase 3 is planned for 442 patients; it would be a double-blind docetaxel-plinabulin versus docetaxel study, with overall survival as the primary endpoint.
Interim analysis is targeted for 2H 2028, with potential launch projected for 2030/31.