|The following article features coverage from the 2021 Annual Meeting of the Society of Hematologic Oncology (SOHO). Click here to read more of Cancer Therapy Advisor’s conference coverage.|
Tisagenlecleucel can produce durable responses in patients with relapsed or refractory follicular lymphoma (FL), according to results from the phase 2 ELARA trial.
The results were presented at the Annual Meeting of the Society of Hematologic Oncology (SOHO) by Nathan Fowler, MD, of the University of Texas MD Anderson Cancer Center in Houston.
Dr Fowler explained that approximately 20% of patients with FL relapse within 2 years of receiving first-line therapy, and these patients typically have worsening treatment outcomes with increasing lines of therapy.
In the phase 2 ELARA trial (ClinicalTrials.gov Identifier: NCT03568461), Dr Fowler and colleagues sought to determine the efficacy and safety of tisagenlecleucel, an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, in adults with relapsed/refractory FL (grades 1-3A).
As of September 28, 2020, the study had enrolled 98 patients, 97 of whom ultimately received tisagenlecleucel. At baseline, the patients’ median age was 57.0 years (range, 29-73 years). A majority of patients (84.5%) had stage III-IV disease, and 64.9% had bulky disease.
Patients had received a median of 4 prior therapies (range, 2-13), 78.4% of patients were refractory to their last treatment, and 59.8% had disease progression within 2 years of their first anti-CD20-containing treatment.
Following study entry, all patients underwent leukapheresis. Before infusion, patients received 1 cycle of lymphodepleting chemotherapy with either bendamustine or fludarabine and cyclophosphamide.
Tisagenlecleucel was given as a single intravenous infusion at a dose of 0.6-6×108 CAR T cells on day 1. Though most patients received tisagenlecleucel as inpatients, 18% received their CAR T cells in an outpatient setting.
Efficacy and Safety Results
The median follow-up was 10.9 months for efficacy (94 evaluable patients) and 10.6 months for safety (97 evaluable patients).
According to an independent review committee, the overall response rate (ORR) was 86%, and the complete response (CR) rate was 66%. According to the investigators, the ORR was 90.4%, and the CR rate was 69.1%.
Some responses deepened over time, with 12 partial responses converting to CRs. All but 1 conversion occurred between month 3 and month 6.
Dr Fowler noted that CR rates were consistent across high-risk groups, including patients who had received a stem cell transplant, those treated with PI3 kinase inhibitors, and those who had relapsed after their last line of therapy or were refractory to it.
The median duration of response, time to next antilymphoma treatment, progression-free survival, and overall survival were not reached. At 6 months, the estimated progression-free survival rate was 76%.
CAR T cells persisted for up to 370 days in responding patients and 187 days in nonresponding patients. Persistence is expected to increase with additional follow-up, Dr Fowler said.
Nearly all patients (99%) experienced adverse events (AEs), and 76.3% experienced at least 1 grade 3 or higher AE. The most common grade 3 or higher AEs were neutropenia (27.8%), anemia (13.4%), and thrombocytopenia (9.3%).
Grade 1-2 cytokine release syndrome (CRS) occurred in 48.5% of patients. There were no cases of grade 3 or higher CRS, and all patients with CRS fully recovered.
Neurologic AEs occurred in 9.3% of patients, but all of these events resolved.
There were 3 deaths on study, all due to disease progression.
“The data from this study suggest that tisagenlecleucel is effective in patients with relapsed/refractory follicular lymphoma, including high-risk subgroups,” Dr Fowler said. “We feel that this study merits continued exploration of this therapy as treatment for adult patients with relapsed/refractory lymphoma following 2 or more lines of therapy.”
Disclosures: This research was supported by Novartis Pharmaceuticals Corporation. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Read more of Cancer Therapy Advisor’s coverage of SOHO 2021 by visiting the conference page.
Schuster SJ, Dickinson M, Dreyling M, et al. Primary analysis of the phase 2 ELARA trial: Tisagenlecleucel efficacy and safety in adult patients with relapsed/refractory follicular lymphoma (r/r FL). Paper presented at: Annual Meeting of the Society of Hematologic Oncology (SOHO); September 8-11, 2021.