FDA expands Breyanzi approval for relapsed or refractory large B-cell lymphoma
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The FDA approved lisocabtagene maraleucel for treatment of adults with relapsed or refractory large B-cell lymphoma after one prior therapy.
The approval applies to use of the agent by patients with refractory disease to first-line chemoimmunotherapy or who relapsed within 12 months of first-line chemoimmunotherapy. It also applies to patients with refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy who are not eligible for hematopoietic stem cell transplantation due to comorbidities or age.
Lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb) is a CD19-directed chimeric antigen receptor T-cell therapy.
The FDA previously approved the therapy for treatment of adults with relapsed or refractory large B-cell lymphoma who received two or more lines of systemic therapy.
The agency based the new indications on results of the phase 3 TRANSFORM study, which included adults with large B-cell lymphoma that was primary refractory to or relapsed within 12 months of front-line therapy.
Researchers randomly assigned patients to lisocabtagene maraleucel or standard therapy. Standard therapy consisted of salvage immunochemotherapy and — if responsive — high-dose chemotherapy and HSCT.
Investigators reported significantly longer median EFS in the lisocabtagene maraleucel group (10.1 months vs. 2.3 months; HR = 0.34; 95% CI, 0.22-0.52). A higher percentage of patients assigned lisocabtagene maraleucel achieved complete response (66% vs. 39%; P < .0001).
“Breyanzi represents a remarkable advance over a nearly 30-year standard of care, providing significantly improved efficacy with a well-established safety profile,” Manali Kamdar, MD, lead investigator of the TRANSFORM study and clinical director of lymphoma services in the division of hematology, hematologic malignancies and stem cell transplantation at University of Colorado Cancer Center, said in a Bristol Myers Squibb-issued press release. “This important milestone reinforces the benefit of offering a CAR T-cell therapy option to patients earlier in their treatment journey, and it’s critical that we begin the work to implement this therapy into standard practice as a second-line treatment in order to help improve outcomes for more patients.”
The phase 2 PILOT study assessed the efficacy of lisocabtagene maraleucel for 61 adults with primary refractory or relapsed large B-cell lymphoma who were not candidates for stem cell transplantation.
Researchers reported an 80% overall response rate and a 54% complete response rate. Median duration of response was 11.2 months, and median duration of response had not been reached among those who achieved complete response.
Safety analyses of the TRANSFORM and PILOT studies showed cytokine release syndrome and neurologic events among patients treated with lisocabtagene maraleucel generally were low grade and resolved with standard protocols without use of prophylactic steroids.
Fewer than half (45%) of patients developed any-grade CRS, with 1.3% of patients developing grade 3 cases. Twenty-seven percent of patients experienced any-grade neurologic events, with 7% of patients experiencing grade 3 cases.
“Patients with large B-cell lymphoma whose disease does not respond to or relapses after first-line therapy often face lengthy and intensive cycles of chemotherapy with the goal of proceeding to stem cell transplant,” Lee Greenberger, PhD, chief scientific officer for Leukemia & Lymphoma Society (LLS), said in the release. “As one of the earliest supporters of CAR-T since the 1990s, LLS is excited to see the FDA approval of a CD19 CAR T-cell therapy that has moved from later lines of therapy to a second-line option, which offers patients with relapsed or refractory large B-cell lymphoma the potential for long-term remission and the hope of a cure.”
To listen to Manali Kamdar, MD, discuss lisocabtagene maraleucel for large B-cell lymphoma, click here.
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