Liso-cel a ‘potential new treatment option’ for advanced follicular lymphoma
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Key takeaways:
- The agent induced a 97% ORR among patients with relapsed or refractory follicular lymphoma.
- Researchers observed low incidence of grade 3 CRS and neurotoxicity, with no grade 4 or grade 5 events.
An infusion of lisocabtagene maraleucel induced deep and durable responses among most adults with relapsed or refractory follicular lymphoma, according to results of the phase 2 TRANSCEND FL trial.
All but three study participants who had objective response to therapy achieved complete responses, findings presented at Society of Hematologic Oncology Annual Meeting showed.
“A single administration of liso-cel in patients with relapsed or refractory follicular lymphoma — particularly as third-line or later treatment — can result in deep and durable remissions,” Loretta J. Nastoupil, MD, associate professor and director of the lymphoma outcomes database at The University of Texas MD Anderson Cancer Center, said during a presentation.
Background
Lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb) — commonly called liso-cel — is a CD19-directed chimeric antigen receptor T-cell therapy.
The FDA approved liso-cel for treatment of adults with relapsed or refractory large B-cell lymphoma.
Novel approaches are needed to treat patients with relapsed or refractory follicular lymphoma, Nastoupil said.
“Although the average person with follicular lymphoma can anticipate a 2-decade-plus life expectancy, this could be coupled with fewer therapies,” she said. “This is especially true for those who progress quickly despite receiving effective strategies, such as chemoimmunotherapies.”
Methodology
Investigators designed the multicenter phase 2 TRANSCEND FL trial to evaluate the safety and efficacy of liso-cel for adults with relapsed or refractory indolent non-Hodgkin lymphoma.
Study participants underwent preconditioning lymphodepletion followed by a single infusion of liso-cel at a target dose of 100 × 106 CAR T cells.
Overall response rate served as the study’s primary efficacy endpoint. Secondary endpoints included complete response rate, duration of response, PFS and safety. Prevalence of B-cell aplasia served as an exploratory endpoint.
At SOHO, Nastoupil presented efficacy results from 107 patients (median age, 62 years; range, 23-80; 62% men) with follicular lymphoma who received at least three previous lines of therapy. Safety results reflected 130 patients (median age, 60 years; range 23-80; 64% men) who received at least two previous lines of therapy.
Key findings
The study achieved its primary endpoint, with an ORR of 97% (95% CI, 91.6-99.4).
The trial also met its key secondary endpoint, showing a complete response rate of 94% (95% CI, 87.5-97.8).
After median follow-up of 16.6 months, median duration of response had not been reached (95% CI, 18 to not reached), and 81.9% of patients had achieved a response to therapy that lasted at least 12 months.
After median follow-up of 17.5 months, median PFS had not been reached (95% CI, 19 to not reached), with 80.7% of patients remaining progression free at 12 months.
The most frequent treatment-related toxicities included neutropenia (65%), cytokine release syndrome (58%) and anemia (38%).
One patient developed grade 3 CRS. No grade 4 or grade 5 cases occurred.
Twenty study participants (15%) experienced neurotoxicity, including three patients (2%) with grade 3 symptoms. No grade 4 or grade 5 events occurred.
Seventy-six percent of patients had B-cell aplasia at baseline; this increased to 100% of the study cohort by 1 month after infusion. The proportion of patients with B-cell aplasia slowly decreased to a low of 63% at 18 months after treatment.
Clinical implications
The results show liso-cel is a highly effective option for individuals with advanced follicular lymphoma, Nastoupil said.
“The case appears solid because responses could be seen across all subgroups in the study and only three patients who responded to therapy failed to achieve an initial complete response,” she said. "In my opinion, liso-cel demonstrated clinically meaningful benefit in patients with relapsed or refractory lymphoma, which does support it as being approved as a potential new treatment option for these patients.”
Collapse
Nastoupil LJ, et al. Abstract IBCL-098. Presented at: Society of Hematologic Oncology Annual Meeting; Sept. 6-9, 2023; Houston.
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