3+ R/R LBCL

An open-label, single-arm trial (N=269)1

TRANSCEND trial: Largest pivotal trial in 3L+ large B-cell lymphoma, including patients with high-risk disease1

Primary endpoints: ORR and safety2
Secondary endpoints: CR, DOR, and OS2

Bridging therapy prior to receiving Breyanzi® was optional.1
Deep and durable complete response in a one-time* infusion1
Response rates (N=192)1
Graph depicting TRANSCEND response rates
Graph depicting TRANSCEND response rates
The IRC-assessed overall response rate in the leukapheresed population (N=287) was 59% (95% CI: 53, 64), with a CR rate of 43% (95% CI: 37, 49) and PR rate of 15% (95% CI: 11, 20).
Efficacy was established on the basis of CR rate and DOR, as determined by an Independent Review Committee per the Lugano 2014 criteria.
DOR rates
Number of responders (n=141/192) Median months (95% Cl)
DOR 16.7 (5.3, NR), range§: 0.0±23.5+
DOR if best
response is CR
NR (16.7, NR), range§: 0.7±23.5+
DOR if best
response is PR
1.4 (1.1, 2.2), range§: 0.0±22.8+
1-month median time to first CR (range: 0.8-12.5 months)1

DOR by best overall response; median DOR: 16.7 months2

Graph showing duration of response by best overall response
Graph showing duration of response by best overall response

CR TotalTotal
104 141
78 83
68 71
64 67
40 43
35 38
17 18
16 17
0 0
Of the 104 patients who achieved CR, 68 (65%) had remission lasting at least 6 months,
and 64 (62%) had remission lasting at least 9 months1,2
Median DOR for PR: 1.4 months (95% CI: 1.1, 2.2)2
3L, third-line; CI, confidence interval; CR, complete response; DOR, duration of response; IRC, Independent Review Committee; NR, not reached; ORR, overall response rate; OS, overall survival; PR, partial response.
*Treatment process can take approximately 2 to 3 months and includes leukapheresis, manufacturing, administration, and adverse event monitoring.
Of the 287 patients who underwent leukapheresis and had radiographically evaluable disease, 27 additional patients achieved a response, apart from the responses noted in graph above. These efficacy results include responses that may have been contributed solely by bridging therapy, product outside of the intended dose range, and out-of-spec product.
Kaplan-Meier method was used to obtain 2-sided 95% confidence intervals.
§A plus sign (+) indicates a censored value.
Overall survival at 2-year follow-up3
mOS: 27.3 months (95% CI: 16.2-45.6)3*
Median (95% Cl) follow-up, 29.3 months (26.2-30.4)
View by response:

CR
PR
NR
Overall survival at 2 year follow up Breyanzi TRANSCEND clinical trial Overall survival at 2 year follow up Breyanzi TRANSCEND clinical trial Overall survival at 2 year follow up Breyanzi TRANSCEND clinical trial Overall survival at 2 year follow up Breyanzi TRANSCEND clinical trial Overall survival at 2 year follow up Breyanzi TRANSCEND clinical trial Overall survival at 2 year follow up Breyanzi TRANSCEND clinical trial
51% of all patients were alive at 2 years3

CR PR NR Total
136 51 70 257
135 46 42 223
128 34 28 190
120 25 17 162
116 16 14 146
112 12 12 136
109 10   130
105 8 11 124
88 6 9 103
62 5 5 72
47 4 4 55
47 3 3 46
40 3 2 35
22 0 1 23
17   1 18
12   1 13
8   0 8
3     3
0     0
  • OS was a secondary endpoint of TRANSCEND and was not statistically tested in the setting of a single-arm trial
  • OS data are not in the USPI and should be interpreted with caution in a single-arm trial. The statistical significance of OS is not known
  • OS included survival data from patients who completed TRANSCEND and enrolled in the subsequent long-term follow-up study
3L, third-line; CI, confidence interval; CR, complete response; DOR, duration of response; mOS, median OS; NR, nonresponder; ORR, overall response rate; OS, overall survival.
*95% Cl: 16.2-45.6.
Reverse Kaplan-Meier method was used to calculate median (95% CI) of follow-up.
TRANSCEND trial2
Graph depicting TRANSCEND trial process.
Graph depicting TRANSCEND trial process.
The trial included both patients who had previous stem cell transplants and patients who did not undergo transplant due to ineligibility or other reasons. There was no prespecified threshold for blood counts; patients were eligible to enroll if they were assessed to have adequate bone marrow function to receive LDC.1
  • Primary endpoints: ORR, safety2
  • Select secondary endpoints: CR, DOR, OS2
TRANSCEND trial design and patient disposition1
Of 299 patients who underwent leukapheresis:
  • 44 (15%) did not receive CAR-positive T cells either due to manufacturing failures (n=2), death (n=29), disease complications (n=6), or other reasons (n=7)
  • 204 (68%) received Breyanzi in the intended dose range, of whom 192 were evaluable for efficacy (main efficacy population); 12 were not evaluable due to absence of PET-positive disease at study baseline or after bridging therapy
  • 51 (17%) either received Breyanzi outside of the intended dose range (n=26) or received CAR‑positive T cells that did not meet the product specifications for Breyanzi (manufacturing failures; n=25)
Patients were allowed to receive bridging therapy prior to receiving Breyanzi. Optional bridging therapy for disease control included intrathecal chemotherapy or radiation therapy for treatment of CNS lymphoma.1
25 patients were treated in an outpatient setting per physicians’ discretion1
Select baseline demographics in the TRANSCEND trial1,2
Characteristics1,2 (N=269)
Median age, years (range) 63 (18-86)
≥65 years/≥75 years 42%/10%
Large B-cell lymphoma subtype, n (%)
DLBCL, NOS 53%
DLBCL transformed from indolent lymphoma 25%
Double-/triple-hit B-cell lymphoma 14%
Primary mediastinal large B-cell lymphoma 7%
Follicular lymphoma, Grade 3B 1%
The TRANSCEND population included patients with prior anti-CD19 therapy (n=12)5
CNS, central nervous system; CR, complete response; CY, cyclophosphamide; DLBCL, diffuse large B-cell lymphoma; DOR, duration of response; FLU, fludarabine; LDC, lymphodepleting chemotherapy; NOS, not otherwise specified; ORR, objective response rate; OS, overall survival; PET, positron emission tomography.

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