NEW YORK – Humanigen reported positive results on Wednesday from a Phase Ib study of lenzilumab plus the CAR T-cell therapy axicabtagene ciloleucel (Gilead's Yescarta) in patients with diffuse large B-cell lymphoma (DLBCL).
In the Phase Ib study, patients were treated with lenzilumab just before receiving the CAR T-cell therapy. In the small six-patient study, called ZUMA-19, the objective response rate for patients treated with lenzilumab and the CAR T-cell therapy was 83 percent, which included four complete responses. The trial evaluated two doses of lenzilumab, 1,800mg and 600mg, and found that there was a response rate of 100 percent in patients taking the 1,800mg dose, which is the recommended Phase II dose. There was also no severe cytokine release syndrome (CRS) or neurotoxicity (NT) in patients who had the 1,800mg dose.
With these results, Humanigen plans to begin a potentially registrational, randomized Phase II trial of lenzilumab with all commercially available CD19 CAR T-cell therapies in DLBCL. That trial will enroll up to 150 patients.
"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," Humanigen CSO Dale Chappell said in a statement. "We believe these data warrant a larger study involving multiple CAR-T therapies."
Humanigen collaborated with Gilead subsidiary Kite Pharma on the ZUMA-19 trial, but the partnership has terminated and both companies will wind down the study.
Last month, the US Food and Drug Administration granted accelerated approval to Gilead's axicabtagene ciloleucel to treat follicular lymphoma.