Axi-cel superior over standard-of-care in older patients with relapsed/refractory large B-cell lymphoma

A subgroups analysis of patients aged 65 years or older in ZUMA-7 demonstrated axi-cel to be superior to standard-of-care for second-line treatment, despite the greater frequency of high-risk features in the axi-cel arm.

The prognosis of patients with early relapsed or refractory large B-cell lymphoma after the receipt of first-line chemoimmunotherapy is poor. Particularly in older patients, outcomes of second-line standard-of-care treatment are inferior and often associated with poor health-related quality of life [1,2]. Recently, results from the phase 3 ZUMA-7 trial (NCT03391466) showed significant improvement in event-free survival with axicabtagene ciloleucel (axi-cel) compared with second-line standard-of-care in patients with relapsed/refractory large B-cell lymphoma [3]. Dr Anna Sureda (University of Barcelona, Spain) presented results on safety, efficacy, and patient-reported outcomes (PROs) in a pre-planned subgroup analysis of ZUMA-7 of patients aged ≥65 years [4].

A total of 109 patients enrolled in ZUMA-7 were aged 65 years or older (median age 70 years); 51 patients were allocated to the axi-cel arm, 58 patients were allocated to the standard-of-care arm (i.e. high-dose chemotherapy plus stem cell transplantation). Compared with standard-of-care patients, more axi-cel patients had high-risk features at baseline.

Median event-free survival (primary endpoint in ZUMA-7) was 21.5 months in the axi-cel arm and 2.5 months in the standard-of-care arm (HR 0.276; P<0.0001). Objective response rate was 88% (75% complete response) in the axi-cel arm and 52% (33% complete response) in the standard-of-care arm. Overall survival rate at 2 years was 64% in the axi-cel arm versus 51% in the standard-of-care arm. Of note, 57% of patients in the standard-of-care arm received subsequent cellular immunotherapy (of protocol).

The safety profile of axi-cel was manageable and consistent with previous studies in refractory large B-cell lymphoma. Cytokine-release syndrome grade ≥3 was observed in 4 (8%) patients in the axi-cel arm (median duration 8 days). In the quality-of-life analysis set (axi-cel n=46; standard-of-care n=42), a clinically meaningful difference in quality-of-life scores was observed in favour of axi-cel from day 100 to 150, suggesting a faster recovery to pre-treatment quality of life.

“This data demonstrates that older patients with relapsed/refractory large B-cell lymphoma, who are frequently considered transplant-ineligible based on age, can safely receive second-line curative intent therapy,” concluded Dr Sureda.

1. Di M, et al. Oncologist. 2021;26:120–132.


2. Oerlemans S, et al. Ann Hematol 2014;93:1705–1715.


3. Locke FL, et al. N Engl J Med 2022;386:640–654.


4. Sureda A, et al. Clinical and patient-reported outcomes in a phase 3 study of axicabtagene ciloleucel (AXI-CEL) vs standard-of-care in elderly patients with relapsed/refractory large B-cell lymphoma (ZUMA-7). Abstract S211. EHA2022 Hybrid Congress, 09–12 June.

 

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Posted on 14 June, 2022