Explore the BREYANZI data from the TRANSFORM trial1
SOC consisted of salvage immunochemotherapy followed by HDCT and autologous HSCT.1
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Adapted from the BREYANZI Product Monograph
The median EFS was NR in the BREYANZI arm after a median follow-up of 17.53 months vs. the SOC arm where the median EFS was 2.4 months after a medium follow-up of 17.49 months (HR=0.356 [95% CI: 0.243-0.522]).
Overall survival (OS; secondary endpoint) data
Median OS was NR in the BREYANZI arm vs. 29.9 months in the SOC arm (HR=0.724 [95% CI:
0.443-1.183]) based on the interim analysis performed at the median follow-up of 17.53 months and 17.49 months, for BREYANZI and SOC, respectively.
3L: third-line; CI: confidence interval; CR: complete response; CRR: complete response rate; HDCT: high-dose chemotherapy; HSCT: hemopoietic stem cell transplant; HR: hazard ratio; NR: not reached; PFS: progression-free survival; PR: partial response; SOC: standard of care.
* TRANSFORM was a Phase 3 open-label, randomized, parallel-group, multicentre trial in adult patients with LBCL primary refractory to or relapsed within 12 months from a complete response to initial chemoimmunotherapy, who were candidates for autologous hemopoietic stem cell transplant. 92 patients underwent leukapheresis and 89 patients received a single intravenous infusion of BREYANZI.
† Per the Lugano criteria, as assessed by independent review committee, and based on primary evidence and analysis for the hypothesis testing purpose (cutoff date: 08 Mar 2021).
‡ EFS was defined as the time from randomization to death from any cause, progressive disease, failure to achieve CR or PR by 9 weeks post-randomization (after 3 cycles of salvage chemotherapy and 5 weeks after BREYANZI infusion) or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first.
§ Based on a stratified Cox proportional hazards model.
¶ P-value is compared with 0.012 of the allocated alpha.
STUDY DETAILS
TRANSFORM trial design1,2
Randomized, open-label, multicentre, parallel-group
Patient population
Adult patients with
R/R large B-cell lymphoma
92 patients
underwent leukapheresis
89 patients
received BREYANZI
Select baseline patient demographics
BREYANZI
SOC
Age range (yrs)
20–74
26–75
<65 ans
61%
73%
Refractory*
73% (67/92)
70% (76/92)
Relapsed†
27% (25/92)
24% (22/92)
Dosing
Single intravenous infusion of BREYANZI
- Dose range of 97–103 x 106 CAR+ viable T cells (consisting of CD8 and CD4 components at a ratio range from 0.8 to 1.2)
or
SOC
- Salvage immunochemotherapy followed by HDCT and autologous HSCT
Primary endpoint:
Event-free survival (EFS)‡
Secondary endpoint:
Complete response rate (CRR), progression-free survival (PFS), overall survival (OS)
BREYANZI was administered in the inpatient (79%) or outpatient (21%) setting.1
BREYANZI TRANSFORM trial inclusion and exclusion criteria1
Inclusion criteria
The study included:
- Adult patients with large B-cell non-Hodgkin lymphoma primary refractory to or relapsed within 12 months from a complete response to initial chemoimmunotherapy, who were candidates for autologous HSCT
- Patients with DLBCL NOS, de novo or transformed indolent NHL, HGBCL with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple hit lymphoma), PMBCL, THRBCL, FL3B
- Patients with ECOG performance status ≤1
- Secondary central nervous system lymphoma involvement
Exclusion criteria
The study excluded patients with:
- A creatinine clearance of <45 mL/min
- Alanine aminotransferase >5 times the upper limit of normal Left ventricular ejection fraction <40%
- Left ventricular ejection fraction <40%
- Absolute neutrophil count <1.0 x 109 cells/L
- Platelets <50 x 109 cells/L in the absence of bone marrow involvement
The inclusion and exclusion criteria were chosen to ensure adequate organ function, and blood counts for HSCT
CAR: chimeric antigen receptor; CR: complete response; DLBCL: diffuse large B-cell lymphoma; ECOG: Eastern Cooperative Oncology Group; FL3B: follicular lymphoma Grade 3B; HDCT: high-dose chemotherapy; HGBCL: high-grade B-cell lymphoma; HSCT: hemopoietic stem cell transplant; NHL: non-Hodgkin lymphoma; NOS: not otherwise specified; PMBCL: primary mediastinal large B-cell lymphoma; PR: partial response; R/R: relapsed or refractory; SOC: standard of care; THRBCL: T cell/histiocyte-rich large B-cell lymphoma.
* Defined as stable disease, progressive disease, PR, or CR with relapse <3 months after first-line therapy.
† Defined as CR with relapse on or after 3 months within 12 months after first-line therapy.
‡ EFS was defined as the time from randomization to death from any cause, progressive disease, failure to achieve CR or PR by 9 weeks post-randomization (after 3 cycles of salvage chemotherapy and 5 weeks after BREYANZI infusion) or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first.
Adapted from the BREYANZI Product Monograph
CI: confidence interval; SOC: standard of care.
* Per the Lugano criteria, as assessed by independent review committee and based on the analysis with cutoff date of 13 May 2022.
† P-value is compared with 0.021 of the allocated alpha.
‡ Cochran-Mantel-Haenszel test.
Median PFS:
BREYANZI NR (95% CI: 12.6-NR), SOC arm 6.2 months (95% CI: 4.3-8.6)
Adapted from Abramson et al. 20232
CI: confidence interval; HR: hazard ratio; NR: not reached.
* Per the Lugano criteria, as assessed by independent review committee and based on the analysis with cutoff date of 13 May 2022.
† Based on a stratified Cox proportional hazards model.
‡ P-value is compared with 0.021 of the allocated alpha.
Learn more about the
safety profile of
BREYANZI
Explore BREYANZI
dosing and
administration
Meet Charlotte and other
patients who are eligible
for BREYANZI
3L: third-line.
References:
1. BREYANZI Product Monograph. Bristol-Myers Squibb Company.
2. Abramson JS, et al. Lisocabtagene maraleucel as second-line therapy for large B-cell lymphoma: primary analysis of the phase 3 TRANSFORM study. Blood. 2023;141(14):1675-1684.