Chimeric antigen receptor (CAR) T-cell therapy was well tolerated by patients with relapsed/refractory large B-cell lymphoma (LBCL) who were not eligible for autologous transplant due to older age or comorbidities.
Efficacy outcomes, including response and survival, were similar among patients not eligible for transplant compared with eligible patients. The results of this retrospective study were published in the British Journal of Haematology.
The study included 404 consecutive patients with relapsed/refractory LBCL who had received at least 2 prior lines of therapy and were approved for treatment with anti-CD19 CAR T-cell therapy. Of these patients, 20% were considered ineligible for transplant.
There were 300 patients who ultimately received CAR T-cell therapy, with 17.7% of patients considered ineligible for transplant. The median age of ineligible patients was 71 compared with 56 among eligible patients (P <.0001). Patients who were ineligible for transplant were more likely to have a left ventricular ejection fraction of 50% or less and a glomerular filtration rate of less than 50 mL/min
Patients who were ineligible for transplant were more likely to receive tisagenlecleucel (52%) than transplant eligible patients (20%). The overall response was similar between the transplant eligible and ineligible cohorts, with rates of 77.4% and 71.3%, respectively (odds ratio [OR], 0.73; 95% CI, 0.36-1.46; P =.37). There was also no significant difference in overall response rate at 3 months according to age, with rates of 47.6% among patients age under 70, 53.7% among patients age 70 to 74, and 28.6% among patients age 75 or older (P =.45).
The 12-month progression-free survival (PFS) was also similar, at 37.7% and 36.8% among patients who were ineligible or eligible for transplant, respectively (hazard ratio [HR], 1.02; 95% CI, 0.70-1.47; P =.92). The 12-month OS was 56.6% among transplant ineligible patients and 56.3% among eligible patients (HR, 0.92; 95% CI, 0.60-1.41; P=.69). In the intention-to-treat population, the median OS was 8.5 months and 11.0 months in transplant ineligible and eligible patients, respectively (HR, 1.07; 95% CI, 0.78-1.45; P=.69).
There was no significant difference between the cohorts for PFS or OS according to age or comorbidities.
CAR-T therapy was generally well tolerated in this study population. Grade 3 or higher cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) developed among 2% and 11% of transplant ineligible patients, respectively. The incidence of any grade and grade 3 or higher CRS or grade 3 or higher neutropenia or thrombocytopenia at 3 months was similar regardless of type of CAR-T therapy or transplant eligibility.
There was also no difference in use of tocilizumab, corticosteroids, or admittance to the intensive care unit. Although ICANS of any grade was modestly more common among patients who were ineligible for transplant (OR, 2.14; 95% CI, 1.05-4.36; P =.036), there was no difference in grade 3 or higher ICANs.
Non-relapse mortality was 7.6% among transplant ineligible patients compared with 6.9% eligible patients (HR, 0.95; 95% CI, 0.32-2.81; P =.93).
“Our data indicate that carefully selected patients with relapsed/refractory LBCL who are not fit for autologous stem cell transplant have favorable outcomes with CD19 CAR T, which provides a potentially curative treatment option for this difficult-to-treat patient group,” the authors concluded in their report.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, or device companies. Please see the original reference for a full list of disclosures.
Kuhnl A, Kirkwood AA, Roddie C, et al. CAR T in patients with large B-cell lymphoma not fit for autologous transplant. Br J Haematol. Published online April 20, 2023. doi: 10.1111/bjh.18810