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‘Encouraging’ results with JCAR017 for relapsed, refractory lymphoma
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High-risk patients with relapsed and refractory diffuse large B-cell lymphoma who received JCAR17 chimeric antigen receptor T-cell therapy had an overall response rate of 80% and a complete remission rate of 55%, according to results of a phase 1 trial presented at the ASCO-SITC Clinical Immuno-Oncology Symposium.
“These data show encouraging efficacy for [patients with very high-risk DLBCL] for whom standard therapies are ineffective,” Jeremy Slade Abramson, MD, clinical director of the center for lymphoma at Massachusetts General Hospital Cancer Center, told HemOnc Today. “The rates of cytokine release syndrome are low, highly manageable and reversible, which supports outpatient administration of this product, which is being actively investigated.”
DLBCL represents about 30% of non-Hodgkin lymphomas and is associated with a poor prognosis. JCAR017 (Juno Therapeutics) is a defined composition, CD19-directed 4-1BB chimeric antigen receptor (CAR) T-cell product that received FDA breakthrough designation for aggressive large B-cell non-Hodgkin lymphoma in 2016.
The trial included 67 patients, 75% of whom had de novo DLBCL and 25% with transformed follicular lymphoma. Nearly a quarter of patients had double- or triple-hit lymphoma.
The cohort had a median of three prior lines of therapy, 66% were chemotherapy refractory, 50% had never achieved complete response to prior therapies, and 42% had failed prior stem cell transplant.
Researchers reported an ORR of 75%. Rate of response was 49% at 3 months and 40% at 6 months.
Cytokine release syndrome — the most common adverse event associated with CAR T-cell therapy — occurred among 36% of patients. One patient experienced severe, grade 4 cytokine release syndrome.
Twenty-one percent of patients experienced neurotoxicity, with 15% experiencing severe neurotoxicity.
“Cytokine release syndrome and neurotoxicity were reversible,” Abramson said, “and among all patients, the 6-month OS is 86%.”
Among 16 patients that had double- or triple-hit lymphoma, the best ORR was 81% and the 3-month complete response was 60%.
“This is an ongoing multicenter seamless design pivotal trial which began with dose finding and dose expansion cohorts and is now accruing the pivotal DLBCL cohort,” Abramson said. “In addition to outpatient administration, we are currently evaluating combination strategies with JCAR017, including immune checkpoint inhibitors and others, with the goal of further enhancing response rate and durability, and ultimately curing more patients with chemotherapy-refractory DLBCL.” – by Chuck Gormley
Reference:
Abramson JS, et al. Abstract 120. Presented at: ASCO-SITC Clinical Immuno-Oncology Symposium; Jan. 25-27, 2018; San Francisco.
Disclosures: Abramson reports research funding from or consultant/advisory roles with Celgene, Genentech/Roche, Gilead Sciences, Millennium, Novartis and Seattle Genetics. Please see the abstract for all other authors’ relevant financial disclosures.