FDA Approves Breyanzi to Treat Relapsed or Refractory Mantle Cell Lymphoma

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The approval of Lisocabtagene maraleucel (Breyanzi; liso-cel) was based on data from the TRANSCEND-NHL-001 study, in which the therapy showed rapid and durable response rates.

The FDA approved lisocabtagene maraleucel (Breyanzi; liso-cel) for the treatment of relapsed or refractory mantle cell lymphoma in adult patients who have received at least 2 lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor, Bristol Myers Squibb announced in a release.1 The therapy is now approved to treat 4 subtypes of non-Hodgkin lymphoma, including large B-cell lymphoma, relapsed or refractory follicular lymphoma, and relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

FDA Approves Breyanzi to Treat Relapsed or Refractory Mantle Cell Lymphoma / Tada Images - stock.adobe.com

FDA Approves Breyanzi to Treat Relapsed or Refractory Mantle Cell Lymphoma / Tada Images - stock.adobe.com

Lisocabtagene maraleucel is a CD19-directed chimeric antigen receptor (CAR) T cell therapy. The approval for relapsed or refractory mantle cell lymphoma was based on data from a cohort of participants in the TRANSCEND-NHL-001 study (NCT02631044), in which the therapy showed rapid and durable response rates over 18 months, as well as a consistent safety profile that was similar to other clinical trials.

About TRANSCEND-NHL-001

Trial Name: Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma

ClinicalTrials.gov Identifier: NCT02631044

Sponsor: Juno Therapeutics

Summary: This open-label Phase 1 study will evaluate the safety, PK, and antitumor activity of modified T cells (JCAR017) administered to adult patients with relapsed or refractory B-cell NHL. The dose and schedule of JCAR017 will be evaluated and modified, as needed, for safety and antitumor activity. We will also determine how long the modified T cells stay in the patient's body and how well JCAR017 works in treating patients with non-Hodgkin's lymphoma whose disease has come back or has not responded to treatment.

“There have been few advances in the treatment of relapsed or refractory mantle cell lymphoma, and prognosis worsens for patients after each subsequent relapse, often leaving them with high disease burden and difficulty achieving deep and durable responses,” Michael Wang, MD, lead investigator on the trial and Puddin Clarke Endowed Professor in the Department of Lymphoma and Myeloma at the University of Texas MD Anderson Cancer Center, said in a release.1 “The approval of Breyanzi offers an important new CAR T treatment option with high rates of lasting responses and a consistent safety profile, which is critically important for these patients who currently have limited options to treat this aggressive disease.”

READ MORE: Amgen Gains FDA Approval for First Interchangeable Biosimilar to Eculizumab

TRANSCEND-NHL-001 is an open-label, multicenter, pivotal, single-arm, seamless-design phase 1 trial to determine the safety, pharmacokinetics and antitumor activity of lisocabtagene maraleucel in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma Grade 3B and mantle cell lymphoma.

The study included 104 leukapheresed patients with relapsed or refractory mantle cell lymphoma, of which 73% were 65 years or older. The median range of previous lines of therapy was 3 and 69% of patients had refractory disease, 53% had BTKi refractory disease, 23% had TP53 mutation, and 8% had secondary CNS lymphoma. Of the 104 patients, 88 received the therapy at a target dose level (DL) of 50 × 106 (DL1) or 100 × 106 (DL2) chimeric antigen receptor-positive T cells.

The primary study outcomes included treatment-related adverse events, dose-limiting toxicities and overall response rate. Secondary outcomes included complete response rate, duration of response and progression-free survival. Results of a primary analysis from the study were published in the Journal of Clinical Oncology.2

Investigators found that lisocabtagene maraleucel demonstrated an overall response rate of 83.1% and a complete response rate of 72.3%. The median duration of response was 15.7 months and progression-free survival was 15.3 months. In the safety analysis, the most common grade 3 or higher adverse events reported were neutropenia, thrombocytopenia and anemia. Additionally, cytokine release syndrome was reported in 61% of patients, neurologic events in 31% and prolonged cytopenia in 40%.

“The approval of Breyanzi brings a new CAR T cell therapy option to patients battling relapsed or refractory MCL,” Meghan Gutierrez, CEO of the Lymphoma Research Foundation, said in a release.1 “Each advance in treatment represents important progress in improving outcomes for patients, and this news builds upon this progress with a new potentially transformative treatment where there are currently limited options.”

Relapsed or refractory mantle cell lymphoma is a rare and aggressive form of mature B-cell non-Hodgkin lymphoma. The condition makes up about 7% of adult-onset non-Hodgkin lymphoma in western countries and has poor long-term survival rates, with a 10-year overall survival rate between 55% and 60%.3

READ MORE: FDA Updates Resource Center

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References
1. U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Breyanzi as a New CAR T Cell Therapy for Relapsed or Refractory Mantle Cell Lymphoma. News Release. Bristol Myers Squibb. May 30, 2024. Accessed May 30, 2024. https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibbs-Breyanzi-as-a-New-CAR-T-Cell-Therapy-for-Relapsed-or-Refractory-Mantle-Cell-Lymphoma/default.aspx
2. Wang M, Siddiqi T, Gordon LI, et al. Lisocabtagene Maraleucel in Relapsed/Refractory Mantle Cell Lymphoma: Primary Analysis of the Mantle Cell Lymphoma Cohort From TRANSCEND NHL 001, a Phase I Multicenter Seamless Design Study. J Clin Oncol. 2024 Apr 1;42(10):1146-1157. doi: 10.1200/JCO.23.02214. Epub 2023 Dec 10. PMID: 38072625.
3. Burkart M, Karmali R. Relapsed/Refractory Mantle Cell Lymphoma: Beyond BTK Inhibitors. J Pers Med. 2022 Mar 1;12(3):376. doi: 10.3390/jpm12030376. PMID: 35330376; PMCID: PMC8954159.
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