Oncology/Hematology > > Leukemia– Results of FELIX research study supported obecabtagene autoleucel’s current FDA approval
by Mike Bassett, Staff Writer, MedPage Today November 27, 2024
Usage of the anti-CD19 CAR T-cell treatment obecabtagene autoleucel (obe-cel; Aucatzyl) led to resilient remissions amongst clients with fallen back or refractory B-cell intense lymphoblastic leukemia (ALL), according to arise from the stage Ib/II FELIX trial.
In an associate of 94 clients with morphologic illness, total remission took place in 77% of those who got a minimum of one infusion of obe-cel, with total remission (CR) in 55% and CR with insufficient hematologic healing in 21%, satisfying the trial’s main endpoint, reported Claire Roddie, MD, of the University College London Cancer Institute, and associates in the New England Journal of Medicine
In the complete research study population of 127 clients who got a minimum of one obe-cel infusion, 99 attained a CR or CR with insufficient hematologic healing. The mean event-free survival (EFS) was 11.9 months, and the approximated 6- and 12-month EFS rates were 65.4% and 49.5%, respectively. The mean general survival (OS) was 15.6 months, and the approximated 6- and 12-month OS rates were 80.3% and 61.1%, respectively.
“Irrespective of illness status, a bulk of clients accomplish total reaction, even in extremely high-risk groups,” Roddie informed MedPage Today“Despite a big percentage of clients with considerable illness concern pre-CAR, we saw extremely little state-of-the-art immunotoxicity, implying that this CAR can be securely provided to clients who may otherwise not be thought about healthy enough for CAR.”
Obe-cel’s current FDA approval was supported by arise from this trial, revealing that 42% of 65 clients accomplished a CR within 3 months. In general, 63% of individuals attained a CR throughout the research study, consisting of 12% with CR and insufficient hematologic healing.
Roddie and coworkers reported that a high occurrence of general remission was observed throughout all client subgroups after obe-cel infusion, however a lower occurrence was seen in clients with a high bone marrow problem (>> 75% bone marrow blasts) compared to those with an intermediate bone marrow concern (5% to 75% bone marrow blasts) before lymphodepletion (65% vs 82%).
They likewise discovered that bone marrow concern before lymphodepletion associated with EFS and OS. Clients with low (<< 5% bone marrow blasts), intermediate, and high bone marrow problem had 12-months EFS rates of 68%, 55%, and 25%, respectively, and 12-month OS rates of 72%, 59%, and 55%, respectively.
This recommends “that low-to-intermediate bone marrow problem is ideal for CAR T-cell effectiveness and toxicity which enhanced bridging treatment methods towards much better growth clearance before CAR T-cell treatment might enhance results,” Roddie and associates composed.
Obe-cel was connected with a low occurrence of extreme immune-related hazardous impacts. Particularly, cytokine release syndrome established in 87 (68.5%) of the 127 clients, however was grade ≥ 3 in just 3 clients. Immune effector cell-associated neurotoxicity syndrome (ICANS) established in 22.8% of clients, with occasions of grade 3 or greater in 9 clients.