In a phase II trial (TRANSCEND FL) reported in The Lancet, Palomba et al found that the chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel was active in patients with relapsed or refractory marginal zone lymphoma (MZL).
Study Details
In the international multicenter trial, 67 patients with at least two previous lines of systemic therapy received a single dose of lisocabtagene maraleucel (100 × 10⁶ CAR+ T cells); a total of 66 were evaluable for efficacy. Bridging therapy was permitted at investigator discretion. The primary endpoint of the study was objective response on independent review committee assessment, with a null hypothesis of ≤ 50%.
Key Findings
Median follow-up was 24.1 months.
Objective response was observed in 63 (95%, 95% confidence interval [CI] = 87.3%–99.1%) of 66 patients, meeting the primary endpoint (P < .0001). Complete response was observed in 41 patients (62%, 95% CI = 49.3%–73.8%, P < .0001). Median duration of response was not reached; responses were ongoing at 24 months in 89% of responders, including both complete and partial responders.
Grade ≥ 3 adverse events occurred in 88% of 67 patients in the safety population; the most common were hematologic, including neutropenia (72%), thrombocytopenia (21%), and leukopenia (19%). Grade ≥ 3 infection occurred in 11 patients (16%). Grade 3 cytokine-release syndrome and neurologic adverse events (no grade 4 or 5 events observed) occurred in three patients each (4%). Adverse events led to death in two patients, due to neutropenic sepsis and T-cell lymphoma.
The investigators concluded: “In patients with relapsed or refractory MZL, lisocabtagene maraleucel showed high rates of durable responses. The safety profile was manageable, with no new safety signals. These results support lisocabtagene maraleucel as a new treatment option for patients with relapsed or refractory MZL.”
M. Lia Palomba, MD, of Memorial Sloan Kettering Cancer Center, New York, is the corresponding author for The Lancet article.
DISCLOSURE: The study was funded by Celgene, a Bristol-Myers Squibb Company. For full disclosures of the study authors, visit thelancet.com.
