FDA approved Breyanzi (lisocabtagene maraleucel), a CD19-directed CAR T-cell therapy, for the treatment of adult patients with large B-cell lymphoma (diffuse large B-cell lymphoma not otherwise specified—including DLBCL arising from indolent lymphoma—high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B) who have:
- Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or
- Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant due to comorbidities or age.
Breyanzi is sponsored by Bristol Myers Squibb.
In 2021, Breyanzi received FDA approval for adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment (The Cancer Letter, Feb. 12, 2021).
The recent approval for Breyanzi was based on results from the pivotal phase III TRANSFORM study, in which adults with LBCL that was primary refractory or relapsed within 12 months of front-line therapy were randomized to receive Breyanzi or standard therapy consisting of salvage immunochemotherapy—and, if responsive, high-dose chemotherapy and HSCT.
The study results, published in The Lancet, showed that Breyanzi (n=92) more than quadrupled median EFS compared to standard therapy (n=92) (10.1 months vs. 2.3 months [HR: 0.34; 95% CI: 0.22-0.52; p<0.0001]).
The majority of patients achieved a CR with Breyanzi compared to less than half with standard therapy (66% [95% CI: 56-76%] vs. 39% [95% CI: 29-50%]; p<0.0001), with median duration of CR not reached in the Breyanzi arm (95% CI: 7.9-NR).
Results also showed that Breyanzi more than doubled PFS versus standard therapy (median PFS: 14.8 months vs. 5.7 months [HR: 0.41; 95% CI: 0.25-0.66; p=0.0001]). In the study, 97% of patients in the Breyanzi arm received treatment, compared to less than half (47%) of patients who completed high-dose chemotherapy and autologous HSCT in the standard therapy arm.
The efficacy of Breyanzi in the second-line setting was also based on data from the phase II PILOT study, in which 61 adults with primary refractory or relapsed LBCL who were not considered candidates for stem cell transplant were treated with Breyanzi. The PILOT study enrolled a broad patient population based on age, performance status and/or organ function, and comorbidities, and regardless of time to relapse following first-line treatment.
Breyanzi showed an overall response rate of 80%, the study’s primary endpoint, and a CR rate of 54%, with median time to CR of one month (range: 0.8-6.9 months). Median duration of response was 11.2 months, with the median duration of response not reached for those patients who achieved a CR.
Full prescribing information for Breyanzi can be found here.
