ASCO20: Update on Orvacabtagene Autoleucel in Relapsed or Refractory Multiple Myeloma
Posted: Thursday, June 18, 2020
Orvacabtagene autoleucel, a B-cell maturation antigen–directed CAR T-cell therapy, dosed at 300, 450, and 600 × 106 CAR-positive T cells exhibited activity and a tolerable safety profile in heavily pretreated patients with relapsed or refractory multiple myeloma. Updated results from the phase I/II EVOLVE trial were presented during the ASCO20 Virtual Scientific Program (Abstract 8504) by Sham Mailankody, MBBS, of the Memorial Sloan Kettering Cancer Center, New York, and colleagues.
“Over 100 patients have been treated in the EVOLVE phase I study. Patients treated at 50 and 150 × 106 CAR-positive T cells were previously reported,” the investigators remarked. “We now report results of the higher-dose levels in patients who received orvacabtagene autoleucel manufactured using the process intended to support commercial use.”
Patients with relapsed or refractory multiple myeloma who received at least three prior treatment regimens (proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody) were assigned to a dosage group. After undergoing lymphodepletion with fludarabine/cyclophosphamide, they were administered orvacabtagene autoleucel at 300 (n = 19), 450 (n = 19), or 600 (n = 13) × 106 CAR-positive T cells.
Of the 51 patients included in the safety analyses, 2 experienced dose-limiting toxicities: a grade 3 neurologic event at 300 × 106 CAR-positive T cells and a grade 4 neutropenia at 450 × 106 CAR-positive T cells. Tocilizumab with or without steroids (78%), anakinra (14%), and vasopressors (6%) were administered to manage cytokine-release syndrome and neurologic events. At day 29, anemia (21%), neutropenia (55%), and thrombocytopenia (44%) of grade 3 or higher were reported. Additionally, infections of grade 3 or higher occurred in 14% of patients. Median progression-free survival was not reached after a median follow-up of 5.9 months. Efficacy analyses (n = 44) revealed objective and complete response rates of 91% and 39%, respectively.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
