First-Line Axi-Cel Appears Effective in High-Risk Large B-Cell Lymphoma

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Axicabtagene ciloleucel (axi-cel) can produce durable responses when given as part of first-line therapy in patients with high-risk large B-cell lymphoma (LBCL), according to the primary analysis of the ZUMA-12 trial.

In fact, more than 70% of patients who received axi-cel remained in response at the data cutoff, said Sattva S. Neelapu, MD, of the University of Texas MD Anderson Cancer Center in Houston.

Dr Neelapu presented these results at the 2021 American Society of Hematology (ASH) Annual Meeting.


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ZUMA-12 (ClinicalTrials.gov Identifier: NCT03761056) enrolled 42 patients with high-risk LBCL. High-risk disease was defined as double- or triple-hit lymphoma or an International Prognostic Index score of 3 or more, plus positive interim PET after 2 cycles of an anti-CD20 monoclonal antibody and an anthracycline-containing regimen.

Forty patients received axi-cel after conditioning chemotherapy, and 37 were evaluable for response. The median follow-up in the evaluable patients was 15.9 months.

The objective response rate was 89%, and the complete response rate was 78%. Complete response rates were consistent across subgroups, Dr Neelapu noted.

The median time to initial response was 1 month. At the data cutoff, 73% of evaluable patients had ongoing responses.

The median duration of response, event-free survival, and progression-free survival were not reached. The estimated 12-month progression-free survival was 75%.

The median overall survival was 24.5 months. The estimated overall survival at 12 months was 91%.

There were 6 deaths — 4 due to progressive disease, 1 due to COVID-19, and 1 due to septic shock, which occurred after the patient began subsequent therapy.

The most common grade 3 or higher treatment-related adverse events were decreased neutrophil count (53%), white blood cell count decrease (43%), and anemia (30%). Prolonged grade 3 or higher cytopenias (on day 30 or later) were seen in 20% of patients.

Cytokine release syndrome (CRS) was observed in all 40 treated patients, but it was primarily grade 1-2 in nature. Grade 3 CRS occurred in 8% of patients. There was no grade 4 or 5 CRS. All CRS events were resolved as of the data cutoff.

Neurological events (NEs) occurred in 73% of patients, and grade 3 or higher NEs occurred in 23%. There were 2 cases of grade 4 NEs and no grade 5 NEs. At the data cutoff, 1 NE (grade 1 tremor) was ongoing.

“Overall, these results indicate that axi-cel may benefit patients exposed to fewer prior therapies and those with high-risk large B-cell lymphoma and suggest further trials of axi-cel in first-line large B-cell lymphoma are warranted,” Dr Neelapu said.

Disclosures: This research was funded by Kite, a Gilead company. 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.

Reference

Neelapu SS, Dickinson M, Munoz J, et al. Primary analysis of ZUMA-12: A phase 2 study of axicabtagene ciloleucel (axi-cel) as first-line therapy in patients with high-risk large B-cell lymphoma (LBCL). Presented at ASH 2021; December 11-14, 2021. Abstract 739.



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