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Lisocabtagene maraleucel shows promise for pretreated non-Hodgkin lymphoma
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CHICAGO — Lisocabtagene maraleucel appeared safe and effective for the treatment of patients with non-Hodgkin lymphoma, according to data presented at the ASCO Annual Meeting.
Lisocabtagene maraleucel (JCAR017, Celgene/Juno Therapeutics) is a CD19-directed chimeric antigen (CAR) T-cell product, which is administered in defined composition at a precise dose of CD8 and CD4 CAR T cells.
“Relapsed/refractory aggressive B-cell non-Hodgkin lymphoma is an unmet medical need for conventional therapies and has overall poor outcomes. Patients with chemotherapy-refractory disease have low response rates to standard therapies and a weak OS,” Jeremy S. Abramson, MD, director of the lymphoma program and Jon and Jo Ann Hagler chair in lymphoma at the Massachusetts General Hospital Cancer Center, and assistant professor of medicine at Harvard Medical School, said during his presentation. “It’s within that context that we assessed lisocabtagene maraleucel.”
The analysis included patients with diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, grade 3b follicular lymphoma and mantle cell lymphoma. Eligibility criteria included adequate organ function.
Researchers treated patients with a lymphodepletion regimen of fludarabine and cyclophosphamide, followed by lisocabtagene maraleucel.
Among 102 evaluable patients (median age, 61 years), researchers observed a best overall response of 75% (95% CI, 65-83) and a best complete remission rate of 55% (95% CI, 45-65).
At 6-months, the ORR was 40% (95% CI, 31-50). Thirty-four percent (95% CI, 25-44) of patients achieved complete remission at 6 months.
Among the pivotal cohort of 37 patients with DLBCL who received a dose of 108 CAR T cells, the best ORR was 78% (95% CI, 62-90), with 62% (95% CI, 45-78) of patients achieving complete remission. Of the patients who achieved complete response at 3 months, 88% remained in complete remission at 6 months.
Median duration of response and median OS were not reached in either the full cohort or the pivotal cohort.
Among 91 patients evaluable for safety, researchers observed cytokine release syndrome in 35% of patients — with one patient developing grade 3 to grade 4 cytokine release syndrome — and neurotoxicity in 19% of patients (grade 3 or grade 4, 12%).
Median time to onset was 5 days for cytokine release syndrome and 10 days for neurotoxicity. Seventeen percent of patients received tocilizumab (Actemra, Genentech) and 21% received corticosteroids.
“Lisocabtagene maraleucel, a CD-19-directed CAR T-cell product with defined composition, induced durable responses in poor-prognosis patients with relapsed/refractory aggressive non-Hodgkin lymphoma. We saw encouraging durable response rates and beyond in our core DLBCL patient population,” Abramson said. “This agent is showing a low and manageable toxicity profile, with very low rates of severe cytokine release syndrome and neurotoxicity.” – by Cassie Homer
Reference:
Abramson JS, et al. Abstract 7505. Presented at: ASCO Annual Meeting; June 1-5, 2018; Chicago.
Disclosures: Abramson reports consultant/advisory roles with Celgene, Genentech/Roche, Gilead Sciences, Novartis and Seattle Genetics; and institutional research funding from Celgene, Genentech, Millennium and Seattle Genetics. Please see the abstract for all other authors’ relevant financial disclosures.