Information about TRANSFORM 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
TRANSFORM: A phase 3, randomised, open-label, multicentre, pivotal trial of BREYANZI vs standard therapy in 2L LBCL transplant-eligible patients who were R/R ≤12 months2,3,4
*Bridging therapy with 1 cycle of R-DHAP, R-ICE or R-GDP was allowed at investigator discretion during BREYANZI manufacturing.3
†Cross over to BREYANZI permitted if they failed to achieve CR or PR after 3 cycles of re-induction chemoimmunotherapy, had disease progression at any time, or needed to start a new anti-neoplastic treatment due to an absence of CR 18 weeks after randomisation.3
‡SOC crossover patients were assessed up to 12 months after BREYANZI infusion.5
Nearly all patients (97%) received BREYANZI in the BREYANZI arm while less than half received HDCT-ASCT in the standard-therapy arm1,3
BREYANZI arm (n=92)3
Patients were to receive BREYANZI infusion 2 to 7 days after completion of LDC, with a planned BREYANZI dose of 100 × 106 CAR+ T cells1,3
Of 92 patients randomised to receive BREYANZI:
- 89 (97%) received BREYANZI3
- Three (3%) did not receive BREYANZI: 1 withdrew consent, 1 had a manufacturing failure, and 1 received a nonconforming CAR T-cell product3
- 58 (63%) patients received bridging therapy3
21% of BREYANZI patients were treated in an outpatient setting3
The long-term follow-up study enrolled 67 patients who received BREYANZI:5
- 3 from the BREYANZI arm (2L)
- 24 who crossed over from the standard therapy arm (3L)
Standard therapy arm (n=92)2
Patients were to receive 3 cycles of chemoimmunotherapy, with complete or partial responders proceeding to 1 cycle of HDCT and ASCT3
Of 92 patients randomised to receive standard therapy:
- 91 (99%) started treatment1
- 43 (47%) received HDCT and ASCT1
58 (63%) patients crossed over and received CAR T cells after failing standard therapy: 57 (62%) received BREYANZI, and 1 received nonconforming product4
62% of standard therapy arm patients crossed over to receive BREYANZI4
The most frequent timepoint for approval for crossover was after completion of chemoimmunotherapy cycle 3, before HDCT and ASCT4
TRANSFORM LTFU: Baseline characteristics5
*At time of randomisation to TRANSFORM; †Defined as stable disease, PD, PR, or CR with relapse <3 months after 1L therapy; ‡Defined as CR with relapse on or after 3 months within 12 months after 1L therapy.5
TRANSFORM: BREYANZI vs standard therapy in 2L R/R LBCL
A phase 3, randomised, open-label, multi-centre trial of BREYANZI vs standard therapy | median follow-up: 33.9 months2
Key eligibility criteria3
- Age 18—75 years
- LBCL R/R ≤12 months after 1L treatment containing an anthracycline and a CD20-targeted agent
- PS ≤1
- Eligible for ASCT
Primary endpoint:3 EFS per IRC by Lugano 2014 criteria
Key secondary endpoints:3 CR rate, PFS and OS
Response2
3-year EFS2 (primary endpoint)
3-year OS2
3-year PFS2
*Rates at 3-years (36 months).
Safety profile: median follow-up 33.9 months2
*TEAEs were defined as AEs occurring or worsening within 90 days after BREYANZI infusion (BREYANZI arm or crossover patients), the last dose of chemotherapy (standard therapy arm), or the start of new antineoplastic therapy, whichever occurred first. AEs in the post-TE period are treatment-related AEs occurring at any time thereafter.
Safety profile: median follow-up 17.5 months4
†Defined as investigator-identified neurological AEs related to BREYANZI.
‡Defined as grade ≥3 central laboratory results at 35 days after BREYANZI infusion or after the start of the last chemotherapy in the standard therapy arm. Laboratory assessments performed after starting a new antineoplastic therapy were not considered for analysis.
§Includes 3 second primary malignancies occurring after crossover.
CRS2
NEs2
The total is 11% due to rounding of percentages.
4% of patients were admitted to the ICU in each arm3
TRANSFORM: long-term follow-up
Median follow-up: 40.1 months | 67 patients enrolled in the LTFU | 43 (64%) from the BREYANZI arm | 24 (36%) crossed over from SOC
Safety profile
Safety results from the LTFU study showed no new signals compared with previous reports from TRANSFORM
*Rates at 4-years (48 months).
Abbreviations
1L, first line; 2L, second line; AE, adverse event; ASCT, autologous stem cell transplant; CD20, cluster of differentiation 20; CI, confidence interval; CR, complete response; CRS, cytokine release syndrome; HDCT, high-dose chemotherapy; HR, hazard ratio; IRC, independent review committee; LBCL, large B-cell lymphoma; LTFU, long-term follow-up; NE, neurological event; No., number; NR, not reached; (m)EFS, (median) event free survival; (m)OS, (median) overall survival; (m)PFS, (median) progression free survival; PS, performance status; R/R, relapsed/refractory; SOC, standard of care; SPM, second primary malignancy; TE, treatment-emergent; TEAE, treatment-emergent adverse event.
References
- BREYANZI® (lisocabtagene maraleucel) UK Summary of Product Characteristics.
- Kamdar M, et al. J Clin Oncol. 2025;43(24):2671–8.
- Kamdar M, et al. Lancet. 2022;399(10343):2294–308.
- Abramson JS, et al. Blood. 2023;141(14):1675–84.
- Kamdar M, et al. Poster presentation ASH 2025; Poster 3710.
2009-GB-2600103 | August 2026