Treated patients had significant improvements in fatigue and lymphoma symptoms.
Lisocabtagene maraleucel (Breyanzi; Bristol Myers Squibb) yielded high response rates and positive patient-reported outcomes (PROs) in patients with large B-cell lymphoma (LBCL) according to new data from the phase 2 TRANSCEND-PILOT study (NCT03483103).1,2
These data were presented at the 2022 American Society of Clinical Oncology (ASCO) meeting, held June 3-7, 2022, in Chicago, Illinois. Clinical data were presented by Alison Sehgal, MD, assistant professor of medicine, University of Pittsburgh School of Medicine, and PRO data were presented by Leo I. Gordon, MD, Abby and John Friend Professor of Oncology Research, Professor of Medicine, Feinberg School of Medicine, Northwestern University.
"For patients with large B-cell lymphoma that is refractory to or relapses after first-line therapy, stem cell transplant has been the only potentially curative treatment option, but the reality is many patients are not candidates for stem cell transplant, leaving limited treatment options," Gordon said in a statement.3 "The results from the PILOT study, including the patient-reported outcomes, show that treatment with liso-cel as a second-line therapy offers durable responses with improved quality of life for patients who historically have had poor prognosis."
The PILOT study leukapheresed 74 participants, 61 of which received liso-cel and 1 of which received a nonconforming product.1 Participants dropped out before infusion due to death (n = 5) and loss of eligibility (n = 5). The median age of patients that received treatment was 74 years (range, 53-84), with 79% of participants being at least 70 years of age. Many participants met 1 (69%), 2 (26%), and 3 (5%) frailty criteria, 26% had a Eastern Cooperative Oncology Group performance status of 2, and 44% had a hematopoietic cell transplantation-specific comorbidity index (HCT-CI) score of at least 3.
Participants had previously completed first-line treatment and 54% were refractory to chemotherapy, 21% relapsed within 12 months, and 25% relapsed after 12 months. Around half (51%) of participants received bridging chemotherapy. Participants were followed-up for a median of 12.3 months (range, 1.2–26.5). Investigators found that overall response rate (ORR) was 80% and complete response rate (CR) was 54%. Median duration of response (DOR) was 12.1 months, progression-free survival (PFS) was 9.0 months, and median overall survival (OS) has not been reached.
Liso-cel had a tolerable safety profile, with treatment-emergent adverse events (TEAE) including neutropenia (51%), fatigue (39%), and CRS (38%), including 1 case of grade 3 CRS (2%). Neurological events occurred in 31% of participants, 5% (n = 3) of which were grade 3 cases. AEs resolved with the use of tocilizumab (7%), corticosteroids (3%), or both (20%). Overall, grade 3 TEAEs occurred in 79% of participants, with grade 5 cases in 2 patients due to COVID-19. Two patients (3%) had grade 3/4 infections and 15 (25%) had at least grade 3 neutropenia at Day 29.
Investigators also assessed PROs and found that completion rates were high (≥ 80%) across most visits for all measures.2 Baseline European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients (EORTC QLQ-C30) mean fatigue scores were worse by at least 10 points at baseline compared to a general noncancer population. These scores, along with pain domain scores, Functional Assessment of Cancer Therapy – lymphoma subscale, and EuroQol Visual Analogue Scale scores improved significantly by least square means through day 545.
Lymphoma symptoms also improved in a clinically meaningful way, along with fatigue, which improved with a more sensitive minimal important difference of 4. No outcomes significantly worsened and 70% of patients demonstrated meaningful improvement in FACT-LymS at month 6.
"With Breyanzi, we have boldly designed a broad clinical trial program in relapsed or refractory LBCL, including patients who are not intended for stem cell transplant after failure of first-line therapy. These results from the PILOT study continue to demonstrate the practice-changing potential of Breyanzi in this setting, delivering on the promise of CAR T cell therapy for more patients,” Anne Kerber, PharmD, senior vice president, Cell Therapy Development, Bristol Myers Squibb, added to the statement.3