EC Approved Liso-cel in Pretreated Relapsed/Refractory Follicular Lymphoma
Liso-cel has been approved by the European Commission for the treatment of adult patients with follicular lymphoma who received 2 or more prior lines of systemic therapy.
Liso-cel has been approved by the European Commission for the treatment of adult patients with follicular lymphoma who received 2 or more prior lines of systemic therapy.
The European Commission (EC) has approved lisocabtagene maraleucel (liso-cel; Breyanzi), a CD19-directed CAR T cell therapy, for the treatment of adult patients with relapsed/refractory follicular lymphoma who have already received 2 or more lines of systemic therapy, according to a press release from the developer, Bristol Myers Squibb.1
Liso-cel elicited an overall response rate (ORR) of 97.1% (95% CI, 91.7%-99.4%) and a complete response rate of 94.2% (95% CI, 87.8%-97.8%) in the third-line treatment of patients with non-Hodgkin lymphoma, including follicular lymphoma. The median time to first response was 0.95 months (range, 0.6-3.3) and at 18 months, 75.7% (95% CI, 66.0%-83.0%) of patients were still in response.
Supporting results come from the global, phase 2 TRANSCEND FL trial (NCT04245839) that evaluated the safety and efficacy of liso-cel in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma.
Previously, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended liso-cel for approval in the aforementioned indication.2 In May 2024, the FDA granted accelerated approval to liso-cel in this population.3
“This additional approval for [liso-cel] in [follicular lymphoma] represents a critical step forward in our mission to deliver on the transformational promise of cell therapy for more patients across Europe,” Emma Charles, senior vice president in Europe Region of Bristol Myers Squibb, stated in the press release.1 “While significant advancements have been made in the last 2 decades, there still remains unmet need for patients. Newer treatments for [follicular lymphoma], like [liso-cel], have shown impactful results in clinical trials, with the opportunity to deliver lasting results in the routine care setting.”
The trial had an estimated enrollment of 276 patients. Inclusion criteria include histologically confirmed relapsed or refractory follicular lymphoma or marginal zone lymphoma; at least 1 prior therapy with an anti-CD20 and alkylating agent; at least 1 prior line of systemic therapy if patients with follicular lymphoma present with high-risk features or 2 or more prior lines of systemic therapy; an ECOG performance status of 0 or 1; adequate organ function; and adequate vascular access for leukapheresis procedure.4
Those with a World Health Organization subclassification of duodenal-type follicular lymphoma, central nervous system-only involvement by malignancy, history of primary malignancy that hasn’t been in remission for 2 years, prior CAR T cell or other genetically-modified cell therapy, presence of acute or chronic graft-versus-host disease, and allogenic-hematopoietic stem cell transplant within 90 days of leukapheresis were excluded from trial participation.
The trial’s primary end point was ORR up to 60 months. Secondary end points include complete response rate, duration of response, progression-free survival, overall survival, and adverse events.
The safety profile in this indication was consistent with previously observed safety data for liso-cel and no new safety signals were observed. Among all patients treated in the trial who were in the second line of treatment, cytokine release syndrome (CRS) occurred in 58% of patients with 0.8% experiencing grade 3 CRS; the median time to onset of CRS was 6 days (range, 1-17). Neurologic toxicities of any grade occurred in 16% of patients with 3% experiencing one of grade 3; the median time to onset of the first event was 8 days (range, 4-16).
Currently, liso-cel is approved in the European Union for the treatment of adult patients who are refractory to or relapsed within 12 months from completion of first-line chemoimmunotherapy and have high-grade B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and grade 3B follicular lymphoma. Additionally, after 2 or more lines of therapy, liso-cel is approved in patients with DLBCL, PMBCL, and grade 3B follicular lymphoma.
References
- Bristol Myers Squibb receives approval from the European Commission to expand use of CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma. News release. Bristol Myers Squibb. March 14, 2025. Accessed March 14, 2025. https://tinyurl.com/2jdsmmmw
- Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma. News release. Bristol Myers Squibb. January 31, 2025. Accessed March 14, 2025. https://tinyurl.com/nhr6tht7
- FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma. News release. FDA. May 15, 2024. Accessed March 14, 2025. https://tinyurl.com/euust4sa
- A study to evaluate the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory indolent B-cell non-Hodgkin Lymphoma (NHL) (TRANSCEND FL). ClinicalTrials.gov. Updated January 15, 2025. Acccessed March 14, 2025. https://tinyurl.com/2kmukuwr
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