Durable response from lisocabtagene maraleucel (liso-cel) treatment has continued after almost two years of follow-up in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).1
Liso-cel demonstrated an extended median OS of 43.2 months in patients with R/R CLL/SLL at a median of 23.8 months (range, 0.4–59.6), and the safety results were similar to previous reports, with no new safety signals observed.
Results come from the TRANSCEND CLL 004 study (NCT03331198), of which Tanya Siddiqi, MD, MBBS, of City of Hope, presented an update during the 66th ASH Annual Meeting and Exposition in San Diego, California.
Patients enrolled in TRANSCEND CLL 004 were administered 50 × 106 at dose level (DL) 1 or 100 × 106 DL2 CAR+ T cells after lymphodepleting chemotherapy. The primary endpoint explored in the study was complete response (CR) or complete response with incomplete marrow recovery (CRi). Objective response rate (ORR) and blood undetectable minimal residual disease (uMRD) rate were key secondary endpoints.
Two sets of patients were evaluated on treatment with liso-cel in the follow-up analysis, including patients who had leukapheresis (safety set) and efficacy-evaluable patients from both the long-term follow-up (LTFU) set and the primary efficacy analysis set (PEAS).
Among the 54 patients from the PEAS, 22 still received treatment as of the data cutoff. At the second DL, a Cr/CRi of 20% remained, resulting in an ORR of 44%. The blood uMRD rate in this population was 64%, and the marrow uMRD rate was 60%. At median follow-up of 31.7 months (95% CI, 21.3–35.5), the median duration of response (DOR) was not reached ([NR] 95% CI, 12.4–NR). The estimated DOR at 36 months was 61% (95% CI, 30–81), and median DOR was NR for the CR-/CRi group.
An 11.9-month (5.7–26.2) median progression-free survival (PFS) and an OS of 26.2 months (11.9–NR) in patients with blood uMRD and 2.8 months (0.8–3.2) in those with detectable blood MRD. Median OS of 43.2 months included 19 patients from the LTFU.
Safety findings showed any-grade/grade three or more cytokine release syndrome (85%,8%), any-grade/grade three or more neurological events (45%,19%), prolonged cytopenia, which was grade ≥ three at day thirty after liso-cel infusion (54%), grade three or more infections (18%), and second primary malignancy (9%), which were consistent with a previous presentation of data.2
According to investigators, the clinical benefit of liso-cel was sustained with longer follow-up. Further, the single agent showcased a favorable benefit-to-risk in R/R CLL/SLL.1
