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Loretta J. Nastoupil, MD, discusses the rationale for launching the phase 2 TRANSCEND FL trial evaluating lisocabtagene maraleucel in patients with relapsed/refractory follicular lymphoma, highlighting the background for investigating this treatment approach.
Loretta J. Nastoupil, MD, associate professor, director, Lymphoma Outcomes Database, section chief, New Drug Development, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the rationale for launching the phase 2 TRANSCEND FL trial (NCT04245839) evaluating lisocabtagene maraleucel (Breyanzi; liso-cel) in patients with relapsed/refractory follicular lymphoma (FL), highlighting the background for investigating this treatment approach.
TRANSCEND FL evaluated the autologous, CD19-directed CAR T-cell therapy liso-cel in patients with relapsed/refractory indolent B-cell non-Hodgkin lymphoma, including FL. Notably, the primary analysis of this trial, which was presented at the 2023 SOHO Annual Meeting, showed that the use of liso-cel in this patient population resulted in deep and durable remissions.
The phase 2, multicenter, single-arm study enrolled adult patients aged 18 and older with who had undergone treatment with chemoimmunotherapy, Nastoupil begins. Because FL is heterogeneous, the study was divided into several cohorts, she notes. The second-line cohort was open to patients whose disease had progressed within 24 months of chemoimmunotherapy or those with high tumor burden, she says. Additionally, in the third- or later-line cohort, all patients had previously received chemoimmunotherapy, she explains. The study stratified patients in this manner to identify which patients were more likely to benefit from treatment, considering the variability of the disease.
As investigators gather more long-term data with liso-cel in FL, it is crucial for them to assess the durability of patients’ remissions, she expands. Data specific to the second-line population may be presented at the upcoming 2023 ASH Annual Meeting, and these findings will be important as the second-line FL setting has several unmet needs. Moreover, a phase 3 trial is launching to compare cell-based therapy with the standard of care, Nastoupil highlights. This study may offer a treatment alternative for patients who are not ideal candidates for other therapies because of their toxicity profiles, Nastoupil explains.
Consequently, it is expected that more patients with FL will be considered for CAR T-cell therapy, she concludes.