Breyanzi demonstrated a 95.5% response price amongst in relapsed/refractory marginal zone lymphoma: © inventory.adobe.com.
Breyanzi (liso-cel; lisocabtagene maraleucel) demonstrated excessive charges of sturdy responses and a constant security profile in sufferers with relapsed or refractory marginal zone lymphoma, in response to a information launch from Bristol Myers Squibb.
This marks the fifth most cancers kind during which Breyanzi has proven excessive charges of sturdy responses and a constant security profile, which is notably essentially the most of any CD19-directed CAR T-cell remedy.
Sufferers with relapsed or refractory marginal zone lymphoma handled with Breyanzi achieved a 95.5% response price, with 62.1% having full responses and 88.6% ongoing at 24 months. At 24 months, length of response, progression-free survival, and general survival charges had been 88.6%, 85.7%, and 90.4%, with median follow-ups of 21.6 to 24.5 months.
“[Breyanzi] achieved excessive, lasting response charges in sufferers with relapsed or refractory marginal zone lymphoma, underscoring the potential of this one-time remedy to considerably enhance affected person outcomes,” Dr. M. Lia Palomba, TRANSCEND FL examine investigator and lymphoma and cell remedy specialist at Memorial Sloan Kettering Most cancers Heart, stated within the information launch. “At the moment, the median survival for sufferers with marginal zone lymphoma with a number of relapses is three to 5 years, signifying an pressing want for transformative therapies that may successfully tackle this hard-to-treat illness.”
Breyanzi continued to point out a constant security profile, with low charges of extreme cytokine launch syndrome and neurologic occasions, in addition to no new security issues recognized.
Cytokine launch syndrome — when the immune system overreacts inflicting fever and irritation — occurred in 76% of sufferers, together with 4% with grade 3 (extreme) unwanted effects and no grade 4 (life-threatening) or grade 5 (dying) unwanted effects. Neurologic unwanted effects had been seen in 33% of sufferers, together with 4% with grade 3 unwanted effects and no grade 4 or 5 unwanted effects. The examine stays ongoing to evaluate general response price and security within the ultimate evaluation.
TRANSCEND FL is a worldwide, part 2 medical trial testing Breyanzi in adults with indolent B-cell non-Hodgkin lymphoma who’ve relapsed or whose illness didn’t reply to prior therapies. This contains two lymphoma varieties: follicular lymphoma and marginal zone lymphoma. The principle purpose of the examine is to measure what number of sufferers expertise tumor shrinkage or disappearance (general response price). Researchers additionally monitor what number of sufferers obtain full remission, how lengthy the response lasts, and the way lengthy sufferers dwell with out illness development.
Inside this trial, the marginal zone lymphoma cohort included sufferers who acquired Breyanzi after not less than two prior therapies. Every affected person was given a dose focusing on 100 x 106 CAR-positive viable T cells.
Breyanzi and its Earlier Approvals
Breyanzi is a CD19-directed CAR T cell remedy that features a 4-1BB costimulatory area, which helps improve the growth and persistence of the CAR T cells within the physique. It’s comprised of a affected person’s personal T cells, that are collected and genetically reengineered to focus on most cancers cells. These modified CAR T cells are then given again to the affected person via a one-time infusion.
In the USA, Breyanzi is authorised to deal with a number of kinds of blood cancers. It’s used for relapsed or refractory giant B-cell lymphoma (LBCL) after not less than one prior therapy. It additionally has accelerated approval for relapsed or refractory power lymphocytic leukemia or small lymphocytic lymphoma after not less than two prior therapies. Moreover, Breyanzi is authorised for relapsed or refractory follicular lymphoma in sufferers who’ve acquired not less than two prior therapies and for relapsed or refractory mantle cell lymphoma within the third-line or later setting.
Breyanzi can also be authorised in Japan, the European Union, Switzerland, the UK, and Canada for related makes use of, together with relapsed or refractory LBCL and follicular lymphoma, with some variations relying on prior strains of remedy.
Reference:
“Bristol Myers Squibb presents first knowledge from the marginal zone lymphoma cohort of the Transcend FL trial demonstrating deep and sturdy responses with Breyanzi (lisocabtagene maraleucel),” Bristol Myers Squibb Information, June 16, 2025.
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