Treatment with lisocabtagene maraleucel in the TRANSCEND CLL 004 study raises no new safety concerns in patients with relapsed/refractory chronic lymphocytic leukemia, says Tatyana Feldman, MD.
Efficacy and safety data from the phase 1/2 TRANSCEND CLL 004 study (NCT03331198) presented during the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition appear tosupport lisocabtagene maraleucel (liso-cel; Breyanzi) as a next-line therapy for patients with relapsed/refractory chronic lymphocytic leukemia (CLL), according to Tatyana Feldman, MD, in an interview with CancerNetwork®.1
Feldman, an attending physician at John Theurer Cancer Center at Hackensack Meridian Health, highlighted data related to responses and survival in both the overall study population (n = 88) and a primary efficacy analysis set including those with disease progression following prior therapy with Bruton tyrosine kinase (BTK) inhibitors and venetoclax (Venclexta; n = 50). Based on these findings, she anticipates that liso-cel will hopefully receive regulatory approval as a treatment option in CLL.
The FDA previously granted priority review to liso-cel as a treatment for relapsed/refractory CLL or small lymphocytic lymphoma in November 2023 based on findings from the TRANSCEND CLL 004 study.2
Transcript:
We have an overall response rate [in the overall population] which sits at [48%] with a complete response rate—which was a primary end point—at [19%]. And what’s very important is that undetectable MRD in the blood for both cohorts was [66%], which is a very high number. As this analysis showed, that translates into duration of response; [these are] very meaningful responses. The duration of complete response is not reached, and duration of partial response is also quite long. We have 24.0 months for the total cohort and [12.4] months for the double-resistant cohort. Time to next therapy, which was a post-hoc analysis, was [18.4] months and [12.4] months, respectively.
These are very reputable numbers for these patient populations.
Overall survival was not reached in patients who achieved a response and [10.7] months for non-responders. From a standpoint of toxicity, there are no novel signals. Cytokine release syndrome [CRS] and immune effector cell-associated neurotoxicity syndrome [ICANS] incidences were 85% and 45%, respectively. However, most of it was grade 1/2 and easily manageable. [Liso-cel] is hopefully going to be approved intervention soon [for] our armamentarium for [patients with] CLL.
This analysis is confirming the duration of the response [of liso-cel]. We have such a long duration of complete responses—which was not reached—as well as a very reputable duration of partial response of [18.4] months. This is a very important [treatment] that should be adopted by the community as a next-line therapy. That’s my opinion, particularly for the patients who progress after BTK inhibitors and BCL2 inhibitors.
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