Liso-Cel NCP Shows Safety, ‘Clinical Benefit’ in Patients With LBCL

Lisocabtagene maraleucel nonconforming product (liso-cel NCP) can benefit patients with relapsed or refractory large B-cell lymphoma (LBCL) without compromising safety, according to a study presented at the 2024 ASCO® Annual Meeting.

The prospective, multicenter, expanded access protocol study was led by Brian Till, MD, of the Fred Hutchinson Cancer Center. A total of 167 patients intended to receive commercial liso-cel, but received liso-cel NCP due to manufacturing outcomes.

The study consisted of a pretreatment period to evaluate patients, a treatment period, and a post-treatment period. During the treatment period, patients were started at the first dose of lymphodepleting chemotherapy and continued through NCP administration at day 1. The median time from leukapheresis to NCP infusion was 50 days. During the post-treatment period, patients were followed up for a period of three months after NCP administration.

The primary endpoint was safety, and the secondary endpoint was efficacy as assessed by overall response rate (ORR) and complete response (CR) rate using the Lugano 2014 criteria. Duration of response, progression-free survival, and overall survival could not be estimated due to the three-month follow-up.

Adverse events (AE) included cytokine release syndrome (42%), prolonged cytopenia (40%), grade ≥ 3 infections (14%), neurological events (8%), immune effector cell–associated neurotoxicity (2%), infusion-related reactions (1%), and secondary primary malignancy (1%). Of 13 patient deaths, six occurred due to AEs, five occurred due to disease progression, and two occurred due to unknown reasons.

Of 118 efficacy-evaluable patients in the first three months, the ORR was 71% (95% CI, 62–79). Approximately half (53%) of patients achieved a CR (95% CI, 43–62), and 19% of patients achieved a partial response (95% CI, 12–27).

“These data add to current clinical experience with liso-cel, show that patients with [relapsed or refractory] LBCL can derive clinical benefit from receiving NCP without compromising safety, and provide important evidence to facilitate clinical decision-making,” concluded Dr. Till and colleagues.

Funding for this study was provided by Juno Therapeutics.

Reference

Till BG, Jacobson CA, Palomba ML, et al. Patients (pts) with R/R large B-cell lymphoma (LBCL) treated with lisocabtagene maraleucel (liso-cel) nonconforming product (NCP) under the Expanded Access Protocol (EAP). Abstract #7026. Presented at the 2024 ASCO® Annual Meeting; May 31-June 4, 2024; Chicago, Illinois