- Primary endpoint: EFS2
- Select secondary endpoints: CR rate, PFS, OS, ORR, DoCR2
Trial design was patient-centric, allowing for crossover to the Breyanzi arm
from the standard therapy arm2
Patients receiving standard therapy treatment were allowed to receive Breyanzi if they failed to achieve CR or PR after 3 cycles of salvage immunochemotherapy, or had disease progression at any time, or if the patient needed to start a new treatment due to efficacy concerns.2
TRANSFORM trial design and patient disposition1
Breyanzi arm (N=92)1
Patients randomized to Breyanzi were to receive lymphodepleting chemotherapy consisting of fludarabine 30 mg/m2/day and cyclophosphamide 300 mg/m2/day concurrently for 3 days followed by Breyanzi infusion 2 to 7 days after completion of lymphodepleting chemotherapy. Breyanzi planned dose of 100 × 106 CAR+ T cells.
Bridging chemotherapy was permitted between leukapheresis and the start of lymphodepleting chemotherapy.
- Of 92 patients randomized to receive Breyanzi, 89 (97%) received Breyanzi
- Fifty-eight (63%) patients received bridging therapy
- One (1.1%; manufacturing failure) patient received a nonconforming product
Standard therapy arm (N=92)1
- Of the 92 patients randomized to receive standard therapy, 91 started treatment and 43 (47%) received high-dose therapy and HSCT
The most common reason for not receiving HSCT was lack of efficacy of the salvage chemotherapy
21% of Breyanzi patients were treated in an outpatient setting
per physicians’ discretion1
Think Breyanzi next for patients who are primary refractory or relapsed
in ≤12 months after 1 prior line of therapy
||Median 59; 20-75 years
|ECOG PS 0/1 at screening
||57% / 42%
|High-grade B-cell lymphoma
|Primary mediastinal large B-cell lymphoma
|DLBCL transformed from indolent lymphoma
|Secondary CNS involvement
* Standard therapy regimens administered, as per the investigator's decision, were R-DHAP, R-ICE, or R-GDP.
† Lymphodepleting chemotherapy regimen consisted of fludarabine 30 mg/m2/day and cyclophosphamide 300 mg/m2/day.
CAR, chimeric antigen receptor; CNS, central nervous system; CR, complete response; DLBCL, diffuse large B-cell lymphoma, DoCR, duration of complete response; ECOG PS, Eastern Cooperative Oncology Group performance status; EFS, event-free survival; HSCT, hematopoietic stem cell transplant; HDT, high-dose therapy; LBCL, large B-cell lymphoma; LDC, lymphodepleting chemotherapy; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; R-DAHP, Rituximab, Dexamethasone, Cytarabine, and Cisplatin; R-GDP, Rituximab, Gemcitabine, Dexamethasone, and Cisplatin; R-ICE, Rituximab, Ifosfamide, Carboplatin, and Etoposide; R/R, relapsed or refractory; SCT, stem cell transplant.