The following article features coverage from the American Society of Hematology 2021 meeting. Click here to read more of Hematology Advisor‘s conference coverage.

Among patients with relapsed or refractory large B cell lymphoma (LBCL), lisocabtagene maraleucel may improve outcomes compared with standard of care (SOC) therapy in the second line, according to research presented at the 2021 American Society of Hematology (ASH) Annual Meeting.

Patients with LBCL with disease that relapses after or who are refractory to first-line therapy have poor outcomes with SOC, including salvage chemotherapy and autologous stem cell transplantation. Novel treatments are, therefore, badly needed in this setting.

Lisocabtagene maraleucel, a CD19-targeting chimeric antigen receptor (CAR)-T cell therapy, previously showed promising efficacy among patients with LBCL who had received at least 2 prior lines of therapy. At the  ASH Annual Meeting, researchers presented interim results from the randomized phase 3 TRANSFORM study (ClinicalTrials.gov Identifier: NCT03575351), which is evaluating the relative safety and efficacy of lisocabtagene maraleucel vs that of SOC among patients with relapsed or refractory LBCL being treated in the second line.


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Overall, 184 patients were randomly assigned to the SOC group (92 patients) or the CAR-T cell group (92 patients). In the SOC and CAR T cell therapy groups, the median age was 58 vs 60 years, respectively; 66% vs 48% of patients were male sex, 62% vs 52% of patients had an Eastern Cooperative Oncology Group performance status of 0 at baseline, and 62% vs 65% of patients had diffuse large B cell lymphoma.

Ninety-one patients in the SOC group were treated; 43 went on to receive autologous stem cell transplantation, of whom 28 had a complete response with chemotherapy. Fifty patients crossed over to the lisocabtagene maraleucel arm. Among 90 patients who received lisocabtagene maraleucel in the experimental arm, 63% received bridging therapy.

Analysis showed that event-free survival was longer in the CAR-T cell therapy arm (median, 10.1 months vs 2.3 months with SOC; P <.0001), and both the overall response rate (86% vs 48%, respectively; P <.0001) and the complete response rate (66% vs 39%, respectively; P <.0001) were improved in the experimental arm.

Progression-free survival (median, 14.8 months in the CAR-T cell therapy group vs 5.7 months in the SOC group; P =.0001) was improved with lisocabtagene maraleucel, though overall survival data were immature at the time of analysis (median, not reached vs 16.4 months, respectively).

Grade 3 or worse treatment-related adverse events were noted in 92% of patients in the lisocabtagene maraleucel group vs 87% of patients treated with SOC. There were 2 cases of tumor lysis syndrome noted, both of which occurred in the SOC group.

Disclosure: The study author(s) declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Read more of Hematology Advisor‘s coverage of the ASH 2021 meeting by visiting the conference page.

Reference

Kamdar M, Solomon SR, Arnason JO, et al. Lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) t cell therapy, versus standard of care (SOC) with salvage chemotherapy (CT) followed by autologous stem cell transplantation (ASCT) as second-line (2l) treatment in patients (pts) with relapsed or refractory (R/R) large B-cell lymphoma (LBCL): results from the randomized phase 3 Transform study. Presented at ASH 2021; December 11-14, 2021. Abstract 91.