|The following article features coverage from the 2021 American Society of Hematology Annual Meeting. Click here to read more of Cancer Therapy Advisor’s conference coverage.|
Brexucabtagene autoleucel (brexu-cel) is safe and effective for patients with relapsed or refractory mantle cell lymphoma (MCL) in the real world, according to a study presented at the 2021 American Society of Hematology (ASH) Annual Meeting.
Most patients in this study would not have been eligible for the ZUMA-2 study (ClinicalTrials.gov Identifier: NCT02601313), which led to the US approval of brexu-cel. However, the overall response rates (ORR) and complete response (CR) rates were comparable between the studies, said Yucai Wang, MD, PhD, of Mayo Clinic in Rochester, Minnesota, who presented the real-world data at ASH.
The real-world study began with 107 patients who had relapsed or refractory MCL. Of this group, 95 patients ultimately received brexu-cel, and 64 also received bridging therapy.
Before brexu-cel, the patients had received a median of 3 prior lines of therapy (range, 1-10), 82% had prior BTK inhibitor treatment, and 44% had disease that was refractory to their last line of therapy.
At day 30, the ORR was 88%, and the CR rate was 66%. The best ORR was 89%, which is comparable to the 93% best ORR observed in ZUMA-2.
ORRs were high across subgroups, Dr Wang said, including for patients with blastoid or pleomorphic variants (95%), TP53-altered disease (87%), BTK inhibitor-naive disease (94%), and for those not meeting ZUMA-2 eligibility criteria (91%).
At a median follow-up of 6.7 months, the median duration of response was not reached. Likewise, the median progression-free survival (PFS) and overall survival (OS) were not reached. The 12-month PFS was 51% in the current study and 61% in ZUMA-2. The 12-month OS was 72% in the current study and 83% in ZUMA-2.
Cytokine release syndrome (CRS) occurred in 91% of the real-world cohort, and 8% of patients had grade 3 or higher CRS. Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 60% of patients, and 35% of patients had grade 3 or higher ICANS. There were no cases of grade 5 CRS or ICANS.
Most patients received tocilizumab (79%) or a steroid (69%) for the management of CRS or ICANS. Anakinra was used in 17% of patients. The use of tocilizumab and steroids was more frequent than in ZUMA-2, Dr Wang said.
“Despite patients having broader characteristics and more patients having high-risk disease [in the real-world study vs ZUMA-2], early clinical outcomes demonstrated feasibility, safety, and efficacy,” Dr Wang said. “Longer follow-up is necessary to confirm long-term safety and efficacy.”
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Read more of Cancer Therapy Advisor’s coverage of the ASH 2021 meeting by visiting the conference page.
Wang Y, Jain P, Locke FL, et al. Brexucabtagene autoleucel for relapsed/refractory mantle cell lymphoma: Real world experience from the US Lymphoma CAR T consortium. Presented at ASH 2021; December 11-14, 2021. Abstract 744.