Information about TRANSCEND Clinical Trials
Breyanzi is indicated for the treatment of adult patients with:1
- Diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy
- Relapsed or refractory DLBCL, PMBCL and FL3B, after two or more lines of systemic therapy
- Relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
- Relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor
TRANSCEND NHL: A phase 1, open-label, single-arm multicentre, trial of BREYANZI in 3L+ LBCL3,4
*Bridging therapy was allowed at investigator discretion during BREYANZI manufacturing, but reconfirmation of PET-positive disease was required before lymphodepletion. †DL1 was tested as a 2-dose regimen, with a second dose of BREYANZI given 14 days after the first dose.3 ‡The original protocol allowed enrolment of patients with an ECOG PS of 0–2 but was later amended to only allow enrolment of patients with an ECOG PS of 0–1.4
TRANSCEND NHL STUDY: Patient flow diagram4
*Other reasons included patient in hospice care with clinical status deteriorating rapidly, site unable to confirm DLBCL histology at pretreatment, patient decided on another treatment, and patient in remission (n=1 each); †Defined as any product wherein one of the CD8+ and CD4+ cell components did not meet one of the requirements to be considered BREYANZI but could be considered appropriate for infusion; ‡Includes all patients who have received ≥1 dose of BREYANZI; §Patient did not return due to health and mental status; ¶Included all patients in the BREYANZI-treated set with PET-positive disease before BREYANZI administration per IRC assessment.
TRANSCEND NHL STUDY: Demographics and baseline characteristics2
*Patients with DLBCL transformed from indolent lymphomas with MYC and BCL2 or BCL6 rearrangements are not included as HGBCL; †The status was chemotherapy refractory if the patient achieved stable disease or progressive disease to last chemotherapy-containing regimen or relapsed <12 months after autologous HSCT; otherwise, the status was chemotherapy sensitive.
TRANSCEND NHL: BREYANZI at 3L+ therapy in R/R LBCL
A phase 1, open-label, single-arm multicentre, trial of BREYANZI in 3L+ LBCL | median follow-up: 19.9 months2,3
Key eligibility criteria3
- Age ≥18 years
- LBCL after ≥2 lines of therapy:
- DLBCL NOS (de novo; transformed from FL, CLL, MZL, or other)
- HGBCL (double/triple hit), PMBCL, FL3B
- Prior HSCT (autologous/allogeneic)
- PS of 0‒1‡
- Patients with secondary CNS lymphoma
- CrCl >30 mL/min/1.73 m2
- LVEF ≥40%
Primary endpoints:2 Incidence of AEs and dose-limiting toxicities; ORR per IRC by Lugano 2014 criteria
Key secondary endpoints:2 CR rate, DOR, PFS, OS and PKs
Response2 (primary endpoint)
2-year DOR2
2-year OS2
2-year PFS2
Safety profile: median follow-up 19.9 months
*TEAEs were defined as AEs occurring or worsening within 90 days after BREYANZI infusion. Any AE occurring after the initiation of another anticancer therapy or BREYANZI retreatment were not considered as a TEAE.
†The post-TE period started from 91 days after BREYANZI infusion or from initiation of another anticancer therapy or BREYANZI retreatment (if patients initiated another anticancer therapy or BREYANZI retreatment before 91 days after BREYANZI infusion.
‡AEs were graded using National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
*Graded according to Lee 2014 criteria.
†Defined as investigator-identified neurological AEs related to BREYANZI.
‡Included grade ≥3 neutropenia, thrombocytopenia, or anaemia not resolved at the Day 29 study visit based on laboratory assessments.
CRS
NEs
TRANSCEND NHL: long-term follow-up
Median follow-up: 20.3 months | 88 patients enrolled in the LTFU
Safety profile
In the post-TE period†, 45% (111/249) of patients experienced an AE of any Grade
25% (62/249) of patients experienced a Grade ≥3 AE
*Rates at 5-years (60 months). †The post-TE period included AEs occurring ≥91 days after BREYANZI infusion.
Abbreviations
3L+, third line or later; AE, adverse event; CAR, Chimeric Antigen Receptor; CLL, chronic lymphocytic leukaemia; CNS, central nervous system; CrCl, creatinine clearance; CR, complete response; CRS, cytokine release syndrome; DL, Dose Level; DLBCL NOS, diffuse large B-cell lymphoma not otherwise specified; (m)DOR, (median) duration of response; (m)DSS, (median) disease-specific survival; ECOG, Eastern Cooperative Oncology Group; FL3B, follicular lymphoma grade 3B; FL, follicular lymphoma; FLU, Fludarabine; HGBCL, high-grade B-cell lymphoma; HSCT, haematopoietic stem cell transplant; IRC, independent review committee; LBCL, large B-cell lymphoma; LTFU, long-term follow-up; LVEF, left ventricular ejection fraction; MZL, marginal zone lymphoma; NE, neurological event; NHL, non-Hodgkin lymphoma; No., number; ORR, overall response rate; (m)OS, (median) overall survival; PET, Positron Emission Tomography; (m)PFS, (median) progression-free survival; PK, pharmacokinetic; PMBCL, primary mediastinal B-cell lymphoma; PS, performance status; R/R, relapsed/refractory; SOC, System Organ Class; TEAE, treatment-emergent adverse event; TE, treatment-emergent.
References
- BREYANZI® (lisocabtagene maraleucel) UK Summary of Product Characteristics.
- Abramson JS, et al. Blood. 2024;143(5):404–16.
- Abramson JS, et al. Lancet. 2020;396(10254):839–52.
- Abramson JS, et al. Poster presentation ASH 2024; Poster 3125.
2009-GB-2600104 | August 2026