The following article features coverage from the American Society of Hematology 2020 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

The anti-CD19 chimeric antigen receptor (CAR) T-cell (CAR-T) therapy axicabtagene ciloleucel (axi-cel) demonstrated significant clinical benefit as a first-line treatment for patients with high-risk large B-cell lymphoma (LBCL), according to the interim results from the phase 2 ZUMA-12 study.

“This study provides new insights into the pharmacology of axi-cel for patients exposed to fewer prior therapies,” said Sattva S. Neelapu, MD, of University of Texas MD Anderson Cancer Center, who presented the results at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.

Axi-cel is currently approved for treatment of adults with relapsed or refractory LBCL after 2 or more lines of therapy based on the results of ZUMA-1. In ZUMA-1 the overall response rate (ORR) was 82% with a complete response (CR) rate of 58%.  

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ZUMA-12 enrolled 31 adults who had 2 criteria for high-risk LBCL. Patients underwent leukapheresis and optional nonchemotherapy bridging at investigator discretion followed by conditioning chemotherapy and a single axi-cel infusion at 2 × 106 per kg. The primary endpoint was investigator-assessed CR rate.

At the planned interim analysis, 32 patients had been treated with axi-cell and had at least 6 months follow-up. Of the 27 response-evaluable patients, the investigator assessed that ORR was 85%, with a CR rate of 74%. With at least 6 months follow-up, 70% of patients had ongoing responses at data cutoff.

The median duration of response, progression-free survival, and median overall survival are not yet reached.

Thirty-two patients were evaluable for safety. The majority (81%) of patients experienced grade 3 or higher adverse events. The most common grade 3 or worse adverse events were white blood cell count decreased (44%), anemia (44%) and encephalopathy (19%). The most common axi-cel–related grade 3 or higher adverse events were encephalopathy (16%), alanine aminotransferase increased (9%), and neutrophil count decreased (9%). One grade 5 event occurred on study due to coronavirus disease 2019 (COVID-19).

Grade 3 or higher cytokine release syndrome occurred in 9% of patients, and 25% experienced neurologic events.

“In ZUMA-12 we observed a higher frequency of CCR7+CD45RA+ T cells in the preinfusion product, which was associated with greater expansion of CAR T cells, suggestive of improved T-cell fitness in first-line treatment,” Dr Neelapu concluded.

Disclosures: Some of the presenters disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. For a full list of disclosures, please refer to the presentation abstract.

Read more of Cancer Therapy Advisor‘s coverage of the ASH 2020 meeting by visiting the conference page.


Neelapu SS, Dickinson M, Ulrickson ML, et al. Interim analysis of ZUMA-12: a phase 2 study of axicabtagene ciloleucel (axi-cel) as first-line therapy in patients (pts) with high-risk large B cell lymphoma (LBCL). Presented at: the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition; December 5-8, 2020. Abstract 405.