TRANSFORM: Liso-cel effective in 2L LBCL
By Megan Lee
Lisocabtagene maraleucel (liso-cel) demonstrated superior and durable efficacy over standard of care (SOC) in second-line large B-cell lymphoma (LBCL), according to 3-year follow-up data from the randomized, phase 3 TRANSFORM trial.
The findings, published in the Journal of Clinical Oncology, support liso-cel as a second-line treatment option for adults with primary refractory or early relapsed LBCL. The study compared the chimeric antigen receptor (CAR) T-cell therapy (target dose, 100 × 106 CAR T cells) with immunochemotherapy followed by high-dose chemotherapy and autologous stem cell transplantation.
At a median follow-up of 33.9 months, the 92 patients given liso-cel achieved a median event-free survival (EFS) of 29.5 months versus 2.4 months for the 92 given SOC. Progression-free survival was not reached in the liso-cel arm, compared with 6.2 months for SOC. The complete response (CR) rate was 74% with liso-cel versus 43% with SOC.
“These data support liso-cel as an effective second-line treatment with curative potential for relapsed/refractory LBCL,” say Manali Kamdar (University of Colorado Cancer Center, Aurora, USA) and colleagues.
A broad range of patients benefited from liso-cel, including those with higher secondary age-adjusted International Prognostic Index scores, older adults, and individuals across diverse non-Hodgkin lymphoma subtypes. EFS consistently favored liso-cel across all subgroups.
Safety outcomes were consistent with previous reports. Although prolonged cytopenias were more frequent in the liso-cel arm, most resolved to grade ≤2 within 2 months. Rates of severe infections were similar between groups, and no T-cell malignancies were reported. Second primary malignancy rates remained low.
The study’s crossover design allowed 66% of patients in the SOC arm to receive liso-cel, complicating overall survival (OS) comparisons. Even with crossover, 36-month OS was still notably higher in the lisocel group, at 63% versus 52% for SOC. “Crossover subgroup results highlight potential benefit of receiving liso-cel in earlier lines, particularly in the second-line versus third-line setting,” the authors note. The study was not powered to detect a statistically significant difference in OS between treatment groups. However, results from prespecified supportive OS analyses “confirmed the potential survival benefit of liso-cel versus SOC.”
Four deaths occurred since the primary analysis: three in the liso-cel arm and one in the SOC arm. Two of the liso-cel deaths were unrelated to disease progression and attributed to mucormycosis and COVID-19 complication.
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