Consider BREYANZI for your adult patients with R/R large B-cell lymphoma who have had ≥2 lines of systemic therapy1
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In an open-label, single-arm trial, BREYANZI demonstrated the following efficacy data in the TRANSCEND trial1*†
Secondary endpoint
DOR‡,§
Median 16.8 months
(n=124 [95% CI: 6.0, NR; range: 0.0¶, 23.5¶])
BREYANZI was administered as a single-dose,
one-time treatment1
CI: confidence interval; CR: complete response; DOR: duration of response; IRC: independent review committee; NR: not reached; ORR: overall response rate; PR: partial response; R/R: relapsed or refractory.
* TRANSCEND was an open-label, multicentre, single-arm trial in adult patients with R/R large B-cell lymphoma. 227 patients underwent leukapheresis and 176 patients received a single intravenous infusion of BREYANZI.1
† Efficacy was established on the basis of the primary endpoint, ORR, in addition to the secondary endpoints which included CR rate and DOR as determined by an IRC.
‡ Per the Lugano 2014 criteria, as assessed by IRC.
§ Deaths after initiation of anti-cancer treatment were considered as events.
¶ Ongoing.
Study details
TRANSCEND trial design
TRANSCEND is the largest published clinical study (N=269) reported to date of CD19-directed CAR T-cell treatment for patients with R/R large B-cell lymphomas2,3*
Open-label, multicentre, single-arm trial
Patient population
Adult patients with
R/R large B-cell lymphoma
227 patients
underwent leukapheresis
176
received BREYANZI
Select baseline patient demographics
Age range: 18–79 years
≥65 years: 40.3%
≥75 years: 8.5%
Chemorefractory†: 69.9%
(123/176)
Refractory‡: 80.7%
(142/176)
Relapsed§: 19.3%
(34/176)
Dosing
Single intravenous infusion of BREYANZI
- Dose range of 60–120 x 106 CAR+ viable T cells (consisting of CD8 and CD4 components at a ratio range from 0.8 to 1.2)
Primary endpoint:
Overall response rate (ORR)
Secondary endpoint:
Complete response (CR), partial response (PR), duration of response (DOR)
BREYANZI was administered in the inpatient (163 patients) or outpatient (13 patients) setting. Safety and efficacy were
consistent across the two groups.1
BREYANZI TRANSCEND trial inclusion and exclusion criteria1
Inclusion criteria
Eligible patients:
- were ≥18 years
- had R/R DLBCL NOS or:
- DLBCL transformed from FL, marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic leukemia, Waldenström’s macroglobulinemia;
- high-grade B-cell lymphoma;
- PMBCL;
- FL grade 3B (FL3B)
- had received at least 2 lines of therapy.
The study included:
- patients with ECOG performance status ≤2
- prior autologous and/or allogeneic hematopoietic stem cell transplant (HSCT)
- secondary central nervous system lymphoma involvement.
Exclusion criteria
The study excluded patients with:
- a creatinine clearance of <30 mL/min
- alanine aminotransferase >5 times the upper limit of normal
- left ventricular ejection fraction <40%.
There was no minimum requirement for blood counts; patients were eligible to enroll if they were assessed by the investigator
to have adequate bone marrow function to receive lymphodepleting chemotherapy.
CAR: chimeric antigen receptor; DLBCL: diffuse large B-cell lymphoma; ECOG: Eastern Cooperative Oncology Group; FL: follicular lymphoma; PMBCL: primary mediastinal large B-cell lymphoma; R/R: relapsed or refractory.
* Comparative clinical significance is unknown.
† Chemorefractory is defined as experiencing stable disease or progressive disease to last chemo-containing regimen or relapsed <12 months after autologous stem cell transplantation.
‡ The status was refractory if a patient achieved less than a CR to last prior therapy.
§ The status was relapsed if a patient achieved CR to last prior therapy.
Secondary endpoint
DOR if best response was CR*†
Median NR
(n=88 [95% CI: 16.8, NR; range: 1.1‡, 23.5‡])
CR: complete response; DOR: duration of response; NR: not reached; PR: partial response.
* Per the Lugano 2014 criteria, as assessed by IRC.
† Deaths after initiation of anti-cancer treatment were considered as events.
‡ Ongoing.
Learn more about the
safety profile of
BREYANZI
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dosing and
administration
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References:
1. BREYANZI Product Monograph. Bristol-Myers Squibb Company.
2. Abramson JS, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020;396(10254):839-852.
3. Data on file. Bristol-Myers Squibb Company.