Significantly improved response rates were shown for liso-cel vs real-world data for SOC in later-line relapsed or refractory mantle cell lymphoma.
Lisocabtagene maraleucel (liso-cel; Breyanzi) demonstrated significantly improved response rates and survival outcomes compared with real-world standard-of-care (SOC) therapies in patients with relapsed or refractory mantle cell lymphoma (MCL) treated in the third line or later, according to an analysis of data from the phase 1 TRANSCEND-NHL-001 trial (NCT02631044), presented at the
Patients in both cohorts had relapsed or refractory MCL and had received at least 2 prior lines of therapy; data for the external SOC cohort were derived from the Flatiron Health and TriNetX Oncology databases. The analysis population included real-world patients treated with current SOC (n = 457) and patients from TRANSCEND-NHL-001 treated with liso-cel (n = 75).
Patients in the liso-cel cohort achieved an overall response rate (ORR) of 79.6% (95% CI, 67.7%-93.7%) compared with 39.4% (95% CI, 35%-44.2%) for the SOC cohort (relative risk [RR], 2.0; 95% CI, 1.7-2.5; P < .0001). Patients in the liso-cel cohort also experienced a complete response (CR) rate of of 64.5% (95% CI, 51.4%-81%) compared with 21.6% (95% CI, 18.1%-25.8%) in the SOC cohort (RR, 3.0; 95% CI, 2.3-4.0; P < .001). Median follow-up times were 18.2 months in the liso-cel cohort and 5.6 months in the SOC cohort.
“These findings collectively further support liso-cel as an effective treatment option for patients with relapsed or refractory MCL in the third-line-or-later setting following progression on a BTK inhibitor, including those with features of high-risk aggressive disease,” presenting study author M. Lia Palomba, MD, said in the presentation.
Palomba is an attending physician, lymphoma specialist, and cellular therapist at Memorial Sloan Kettering Cancer Center in New York, New York.
After prior data from the MCL cohort of TRANSCEND NHL 001 supported the May 2024
TRANSCEND-NHL-001 is an open-label study that enrolled patients aged 18 years or older who had relapsed or refractory disease following prior therapy, had received at least 2 prior lines of therapy with at least 1 including a BTK inhibitor, had an ECOG performance status of 0 or 1, and had no prior exposure to chimeric antigen receptor (CAR) T-cell therapy or other genetically modified cell therapies.1,3
If patients had active central nervous system malignancy involvement, graft-vs-host disease, or received prior CAR T-cell therapy, they were not enrolled in the trial.3
Patients in the liso-cel cohort received the CAR T-cell therapy at a target dose of 50 × 10⁶ or 100 × 10⁶ CAR-positive T cells; ORR per investigator assessment was the trial’s primary end point, whereas CR rate, progression-free survival (PFS), overall survival (OS), time to next treatment (TTNT), and duration of response (DOR) were secondary end points.1
To be included in the real-world analysis, patients had to be 18 years or older with relapsed/refractory disease following their last line of therapy. At least 2 lines of therapy, including a regimen containing a BTK inhibitor, were required, and no prior CAR T-cell therapy was permitted. An ECOG performance status of 0 to 1 was also required.
Baseline characteristics were balanced using inverse probability of treatment weighting (IPTW) to account for age, ECOG performance status, blastoid MCL morphology, prior autologous stem cell transplant, number of prior therapies, refractory status following prior therapy, and BTK inhibitor–refractory status. Simplified Mantle Cell Lymphoma International Prognostic Index scores were the only characteristic that remained unbalanced after IPTW adjustment.
Third- or later-line treatment regimens for patients in the SOC cohort were chemoimmunotherapy (22.1%), covalent BTK inhibitors (19.7%), lenalidomide (Remlivid)–based regimens (17.7%), bortezomib (Velcade)–based regimens (10.9%), CAR T-cell therapy (10.1%), venetoclax (Venclexta)–based regimens (6.3%), pirtobrutinib (Jaypirca; 4.2%), chemotherapy (3.9%), stem cell transplant (2.6%), and other (2.4%).
Patients in the liso-cel cohort achieved a median PFS of 7.8 months (95% CI, 0-18.4) vs 4.1 months (95% CI, 3.3-4.8) for the SOC cohort (HR, 0.65; 95% CI, 0.44-0.97 P = .0355). The liso-cel cohort had a median OS of 18.2 months (95% CI, 9.4-27.0) compared with 7.5 months (95% CI, 6.0-9.1) for the SOC cohort (HR, 0.60; 95% CI, 0.39-0.93; P = .0215).
The median TTNT for the liso-cel and SOC cohorts was 8.8 months (95% CI, 0.6-16.9) and 5.4 months (95% CI, 4.1-6.7), respectively (HR, 0.71; 95% CI, 0.46-1.10; P = .1249). The median DOR was 15.0 months (95% CI, 11.4-18.7) with liso-cel vs 10.9 months (95% CI, 5.2-16.6) with SOC (HR, 0.92; 95% CI, 0.57-1.47; P = .7149).
