2L TRANSFORM trial

A Phase 3, randomized, open-label, multicenter,
pivotal trial (N=184)1

TRANSFORM trial evaluated Breyanzi®
head-to-head vs standard therapy in 2L LBCL patients who were R/R ≤ 12 months and potential candidates for transplant1

Standard therapy in the TRANSFORM trial was chemoimmunotherapy followed by high-dose therapy + SCT1
Primary endpoint: EFS (evaluated at 6.2 months)2
Median follow-up at primary analysis was 17.5 months.4
Select secondary endpoints (evaluated at primary analysis): CR rate, PFS, ORR, and DoCR2
Median follow-up at interim analysis was 6.2 months.4
Bridging therapy prior to receiving Breyanzi was optional and patients in the standard therapy arm were allowed to cross over to the Breyanzi arm.2
Patients receiving standard therapy 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
Over 4x improvement in mEFS over standard therapy in patients who were R/R ≤12 months1*
At 6.2 months median follow-up, mEFS was 10.1 months for Breyanzi vs 2.3 months for standard therapy1
  • 66% reduction in risk of EFS events; HR: 0.34, 95% CI (0.22, 0.52)1†
  • P<0.00011‡
At 17.5 months (median) follow-up, mEFS was not reached in patients who received Breyanzi at primary analysis5
  • Breyanzi mEFS: NR, 95% CI: (9.5, NR)
  • Standard therapy mEFS: 2.4 months, 95% CI: (2.2, 4.9)
Graph showing 4x improvement in mEFS over standard therapy.
Graph showing 4x improvement in mEFS over standard therapy.

Number of subjects at risk
Months BREYANZI Standard therapy
0 92 92
1 87 66
2 76 39
3 62 32
4 59 27
5 55 22
6 52 19
7 48 19
8 45 19
9 24 12
10 20 12
11 17 10
12 5 3
13 3 2
14 3 2
15 3 2
16 3 2
17 0 0
Symbols represent censored observations.
EFS is defined as the time of randomization to death from any cause, progressive disease, failure to achieve CR or PR by 9 weeks post-randomization, or start of new lymphoma therapy due to efficacy concerns, whichever occurs first.1
Median PFS was not reached at 17.5 months median follow-up5*
  • Breyanzi mPFS: NR, 95% CI: (12.6, NR); HR: 0.40, 95% CI: (0.26, 0.62)†
  • Standard therapy mPFS: 6.2 months, 95% CI: (4.3, 8.6)
  • P<0.0001§
Graph showing PFS 2x that of standard therapy
Graph showing PFS 2x that of standard therapy

Number of subjects at risk
Months BREYANZI Standard therapy
0 92 92
1 88 66
2 79 42
3 63 33
4 60 27
5 56 22
6 53 19
7 49 19
8 46 19
9 25 12
10 21 12
11 18 10
12 6 3
13 3 2
14 3 2
15 3 2
16 3 2
17 0 0
Symbols represent censored observations. Interim 6.2-month median follow-up: 14.8 months for Breyanzi vs 5.7 months for standard therapy. PFS is defined as the time from randomization to progressive disease or death from any cause, whichever
occurs first.2
Overall survival of patients treated with Breyanzi vs standard therapy5
73% of Breyanzi patients and 61% of standard therapy patients were alive at time of 18-month follow-up5¶
  • Breyanzi mOS: NR, 95% CI: (29.5, NR); HR: 0.72, 95% CI: (0.44, 1.18)†
  • Standard therapy mOS: 29.9 months, 95% CI: (17.9, NR)
Graph showing percentage of living patients at 2 years
Graph showing percentage of living patients at 2 years

Number of subjects at risk
Months BREYANZI Standard therapy
0 92 92
1 92 88
2 88 81
3 84 79
4 81 74
5 78 66
6 74 62
7 68 60
8 63 58
9 43 41
10 34 30
11 30 21
12 16 15
13 13 12
14 10 10
15 7 5
16 5 3
17 1 1
18 0 1
Overall survival (OS) was a secondary endpoint of the TRANSFORM study.4
  • At primary analysis, OS was not statistically significant
  • Data was limited for OS because of the number of patient deaths and was based on the ITT principle
  • Estimates were not adjusted for patient crossover
  • Median follow-up in both arms: 17.5 months.
OS is defined as the time from randomization to death due to any cause.
CI, confidence interval; CR, complete response; DoCR, duration of complete response; EFS, event-free survival; HR, hazard ratio; IRC, independent review commitee; ITT, intent-to-treat; LBCL, large B-cell lymphoma; NR, not reached; mEFS, median event-free survival; mOS, median overall survival; ORR; overall response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; R/R, relapsed or refractory; SCT, stem cell transplant.
* Per the Lugano criteria, as assessed by an IRC.
† Based on stratified Cox proportional hazards model.
‡ P-value is compared with 0.012 of the allocated alpha this prespecified interim analysis.
§ P-value is compared with 0.021 of the allocated alpha for the primary analysis.
The tick marks represent censored patients. Patients alive or lost to follow up by data cutoff were censored at the last date known to be alive.
TRANSFORM trial1
2L TRANSFORM trial process
2L TRANSFORM trial process
  • 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
Select demographics1,2
Characteristics1,2 Characteristics (N=184)
Age, range Median 59; 20-75 years
ECOG PS 0/1 at screening 57% / 42%
Primary refractory 73%
Relapsed 27%
LBCL subtypes
DLBCL NOS 55%
High-grade B-cell lymphoma 23%
Primary mediastinal large B-cell lymphoma 10%
DLBCL transformed from indolent lymphoma 8%
Secondary CNS involvement 2%
* 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.
74% of patients treated with Breyanzi experienced deep and durable complete response5*
Breyanzi
(N=92)†		 Standard therapy (N=92)*
ORR5 87% (80/92, 95% CI: 78.3, 93.1) 49% (45/92, 95% CI: 38.3, 59.6)
CR5 74% (68/92, 95% CI: 63.7, 82.5)ठ43% (40/92, 95% CI: 33.2, 54.2)
mDoCR5 NR (95% CI: NR, NR) 9.3 months (95% CI: 5.1, NR)
More than twice as many patients in the Breyanzi arm went on to receive treatment1
  • 97% of patients (89/92) received Breyanzi
  • 47% of patients (43/92) received treatment with HDT + HSCT in the standard therapy arm
CI, confidence interval; CR, complete response; HDT, high-dose therapy; HSCT, hematopoietic stem cell transplant; mDoCR, median duration of complete response; NR, not reached; ORR, overall response rate; PR, partial response.
* At 17.5 months median follow-up.
† Interim 6.2-month median follow-up: CR of 66% for Breyanzi vs 39% for standard therapy.
‡ Per the Lugano criteria, as assessed by an IRC.
§ P<0.0001; Cochran-Mantel-Haenszel test. P-value is compared with 0.021 of the allocated alpha for the primary analysis.
EXPLORE SAFETY ACROSS BREYANZI TRIALS
Important Safety Information
LESS
Important Safety Information

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.
  • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed.
  • BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS.
CYTOKINE RELEASE SYNDROME
Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Among patients receiving BREYANZI for LBCL (N=418), CRS occurred in 46% (190/418), including ≥ Grade 3 CRS (Lee grading system) in 3.1% of patients.
In patients receiving BREYANZI after two or more lines of therapy for LBCL, CRS occurred in 46% (122/268), including ≥ Grade 3 CRS in 4.1% of patients. One patient had fatal CRS and 2 had ongoing CRS at time of death. The median time to onset was 5 days (range: 1 to 15 days). CRS resolved in 98% with a median duration of 5 days (range: 1 to 17 days).
In patients receiving BREYANZI after one line of therapy for LBCL, CRS occurred in 45% (68/150), including Grade 3 CRS in 1.3% of patients. The median time to onset was 4 days (range: 1 to 63 days). CRS resolved in all patients with a median duration of 4 days (range: 1 to 16 days).
The most common manifestations of CRS (≥10%) included fever (94%), hypotension (42%), tachycardia (28%), chills (23%), hypoxia (16%), and headache (12%).
Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).
Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI.
Of the 418 patients who received BREYANZI for LBCL, 23% received tocilizumab and/or a corticosteroid for CRS, including 10% who received tocilizumab only and 2.2% who received corticosteroids only.
NEUROLOGIC TOXICITIES
Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred.
In patients receiving BREYANZI after two or more lines of therapy for LBCL, CAR T cell-associated neurologic toxicities occurred in 35% (95/268), including ≥ Grade 3 in 12% of patients. Three patients had fatal neurologic toxicity and 7 had ongoing neurologic toxicity at time of death. The median time to onset of neurotoxicity was 8 days (range: 1 to 46 days). Neurologic toxicities resolved in 85% with a median duration of 12 days (range: 1 to 87 days).
In patients receiving BREYANZI after one line of therapy for LBCL, CAR T cell-associated neurologic toxicities occurred in 27% (41/150) of patients, including Grade 3 cases in 7% of patients. The median time to onset of neurologic toxicities was 8 days (range: 1 to 63 days). The median duration of neurologic toxicity was 6 days (range: 1 to 119 days).
In all patients combined receiving BREYANZI for LBCL, neurologic toxicities occurred in 33% (136/418), including ≥ Grade 3 cases in 10% of patients. The median time to onset was 8 days (range: 1 to 63), with 87% of cases developing by 16 days. Neurologic toxicities resolved in 85% of patients with a median duration of 11 days (range: 1 to 119 days). Of patients developing neurotoxicity, 77% (105/136) also developed CRS.
The most common neurologic toxicities (≥ 5%) included encephalopathy (20%), tremor (13%), aphasia (8%), headache (6%), dizziness (6%), and delirium (5%).
CRS AND NEUROLOGIC TOXICITIES MONITORING
Monitor patients daily for at least 7 days following BREYANZI infusion at a REMS-certified healthcare facility for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 4 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time.
BREYANZI REMS
Because of the risk of CRS and neurologic toxicities, BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS. The required components of the BREYANZI REMS are:
  • Healthcare facilities that dispense and administer BREYANZI must be enrolled and comply with the REMS requirements.
  • Certified healthcare facilities must have on-site, immediate access to tocilizumab.
  • Ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after BREYANZI infusion, if needed for treatment of CRS.
  • Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer BREYANZI are trained on the management of CRS and neurologic toxicities.
Further information is available at www.BreyanziREMS.com, or contact Bristol-Myers Squibb at 1-888-423-5436.
HYPERSENSITIVITY REACTIONS
Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO).
SERIOUS INFECTIONS
Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion.
In patients receiving BREYANZI for LBCL, infections of any grade occurred in 36% with Grade 3 or higher infections occuring in 12% of all patients. Grade 3 or higher infections with an unspecified pathogen occurred in 7%, bacterial infections occurred in 4.3%, viral infections in 1.9% and fungal infections in 0.5%.
Febrile neutropenia developed after BREYANZI infusion in 8% of patients with LBCL. Febrile neutropenia may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.
Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines.
Avoid administration of BREYANZI in patients with clinically significant active systemic infections.
Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells.
In patients who received BREYANZI for LBCL, 15 of the 16 patients with a prior history of HBV were treated with concurrent antiviral suppressive therapy. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines.
PROLONGED CYTOPENIAS
Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion.
Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 36% of patients with LBCL and included thrombocytopenia in 28%, neutropenia in 21%, and anemia in 6%.
Monitor complete blood counts prior to and after BREYANZI administration.
HYPOGAMMAGLOBULINEMIA
B-cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with BREYANZI.
In patients receiving BREYANZI for LBCL, hypogammaglobulinemia was reported as an adverse reaction in 11% of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 28% of patients.
Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated.
Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI.
SECONDARY MALIGNANCIES
Patients treated with BREYANZI may develop secondary malignancies. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol-Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Due to the potential for neurologic events, including altered mental status or seizures, patients receiving BREYANZI are at risk for developing altered or decreased consciousness or impaired coordination in the 8 weeks following BREYANZI administration. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, for at least 8 weeks.
ADVERSE REACTIONS
The most common nonlaboratory adverse reactions (incidence ≥ 30%) are fever, CRS, fatigue, musculoskeletal pain, and nausea.
The most common Grade 3-4 laboratory abnormalities (≥ 30%) include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.
Indication
BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:
  • refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or
  • refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or
  • relapsed or refractory disease after two or more lines of systemic therapy.
Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.
References
  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2023.
  2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V5.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed July 7, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.
  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2023.
  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2023.
  2. Kamdar M, Solomon S, Arnason J, et al. Lisocabtagene maraleucel, a CD19-directed chimeric antigen receptor T cell therapy, versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma: results from the randomized phase 3 TRANSFORM study. Presented at the 63rd American Society of Hematology Annual Meeting & Exposition; December 11-14, 2021; Atlanta, GA.
  3. Data on file. BMS-REF-LIS-0016. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  4. Kamdar M, Solomon S, Arnason J, et al. Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from the randomized phase 3 interim analysis of an open-label, randomised, phase 3 trial. Lancet. 2022;399(10343):2294-2308.
  5. Abramson J, Solomon S, Arnason J, et al. Lisocabtagene maraleucel (liso-cel) versus standard of care (SOC) with salvage chemotherapy followed by autologous stem cell transplantation (ASCT) as second-line (2L) treatment in patients with relapsed or refractory large B-cell lymphoma (LBCL): primary analysis of the randomized, phase 3 transform study. Presented at the 64th American Society of Hematology Annual Meeting & Exposition; December 10-13, 2022; New Orleans, Louisiana.
  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2023.
  2. Sehgal A, Hoda D, Riedell P, et al. Lisocabtagene maraleucel as a second-line therapy for relapsed or refractory large B-cell lymphoma in patients not intended for hematopoietic stem cell transplantation: primary analysis from the phase 2 PILOT study. Presented at the American Society of Oncology Annual Meeting; June 3-7, 2022; Chicago, IL.
  3. Data on file. BMS-REF-LIS-0019. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2023.
  2. Abramson JS, Palomba ML, Gordon LI, 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. TRANSCEND DOR. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  4. Abramson J, Palomba M, Gordon L, et al. Two-year follow-up of TRANSCEND NHL 001, a multicenter phase 1 study of lisocabtagene maraleucel in relapsed or refractory large B-cell lymphomas. Presented at the 63rd American Society of Hematology Annual Meeting & Exposition; December 11-14, 2021; Atlanta, GA.
  5. Data on file. TRANSCEND CD19. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2023.
  2. Kamdar M, Solomon S, Arnason J, et al. Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial. Lancet. 2022;399(10343):2294-2308.
  3. Abramson J, Palomba M, Gordon L, et al. Two-year follow-up of TRANSCEND NHL 001, a multicenter phase 1 study of lisocabtagene maraleucel in relapsed or refractory large B-cell lymphomas. Presented at the 63rd American Society of Hematology Annual Meeting & Exposition; December 11-14, 2021; Atlanta, GA.

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