HGEN - Humanigen achieves positive outcome for Lenzilumab in small early-stage study

Humanigen ([[HGEN]] -2.8%) announced positive data from the Phase 1b portion of the ZUMA-19 trial which involved six patients in two cohorts.The study was designed to evaluate the efficacy and safety of Lenzilumab with CAR-T in diffuse large B-cell lymphoma (DLBCL). The overall ORR was 83% (n=5) which included four complete responses (“CR”).At the recommended Phase 2 dose of 1,800 mg, the objective response rate (“ORR”) was 100% (n=3) with no severe cytokine release syndrome or severe neurotoxicity, the company said.“These encouraging results from ZUMA-19 provide further proof of concept that lenzilumab may break the linkage between efficacy and toxicity (CRS and NT) widely-associated with CAR-T, and may improve durability of response,” noted Dale Chappell, the chief scientific officer, Humanigen.The company has planned a randomized, potentially pivotal, Phase 2 study with Lenzilumab combined with all commercially available CD19 CAR-T therapies in DLBCL.Humanigen has ended the collaboration with Kite Pharma for ZUMA-19. The

For further details see:

Humanigen achieves positive outcome for Lenzilumab in small early-stage study