The addition of rituximab to axicabtagene ciloleucel (axi-cel) demonstrated promising efficacy with no new safety signals among patients with refractory large B-cell lymphoma (R-LBCL), according to results of a phase 2 study presented at the 2022 ASCO Annual Meeting.

“Approximately 60% of patients have no response or relapse within 2 years after treatment [with axi-cel], highlighting the need for more therapeutic strategies,” the authors wrote in their poster. In the ZUMA-1 trial, the ORR was 83% and 58% of patients achieved CR with axi-cel within a median follow-up of 27.1 months among patients with refractory LBCL.

The multicenter, phase 2 ZUMA-14 trial treated 26 patients with refractory LBCL with rituximab plus a standard conditioning regimen followed by axi-cel. All patients had received at least 2 prior lines of therapy.  The primary endpoint was investigator-assessed complete response (CR) rate. Secondary endpoints included objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS).


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At baseline, the median age was 62 and 54% of patients were male. The majority of patients had stage III or IV disease at 81%, and extranodal disease was present among 62% of patients.

There were 65% of patients who achieved CR. The ORR was 88% with a median DOR of 17.6 months. It was estimated that 65% of patients maintained response at 1 year. At a median follow-up of 17 months, 57% of patients were still in CR and 65% had an ongoing response.

The median PFS was 18.6 months, and the median OS was not yet reached. The estimated 1-year PFS and OS were 58% and 77%, respectively.

Grade 3 or higher adverse events (AEs) were common, developing among 92%, with the most common being neutropenia and anemia. None of the patients developed grade 3 cytokine release syndrome. There were 15% of patients with grade 3 or higher neurologic events, all of which resolved. Six patients died as a result of progressive disease.

The authors conclude that “overall, axi-cel in combination with rituximab in patients with relapsed/refractory LBCL showed encouraging activity with a manageable safety profile.”

Disclosures: This study was supported by Kite, a Gilead Company. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies.

Reference

Strati P, Leslie LA, Shiraz P, et al. Axicabtagene ciloleucel (axi-cel) in combination with rituximab (Rtx) for the treatment (Tx) of refractory large B-cell lymphoma (R-LBCL): outcomes of the phase 2 ZUMA-14 study. Presented at ASCO 2022; June 3-7, 2022. Abstract 7567.