Dr Park on Emerging Data Shaping the Evolving Role of Obe-Cel in R/R ALL

“Obe-cel has a good safety profile, even for patient [with] high-burden [disease]. What is encouraging [about obe-cel] is that real-world data match what was observed in clinical trials in terms of efficacy and toxicity.”

Jae Park, MD, chief of the Cellular Therapy Service at Memorial Sloan Kettering Cancer Center, discussed the CAR T-cell therapy obecabtagene autoleucel (obe-cel; Aucatzyl) and its role in the acute lymphoblastic leukemia (ALL) treatment paradigm. Obe-cel was approved by the FDA for relapsed/refractory B-cell precursor ALL (B-ALL) in November 2024, based on data from the phase 1/2 FELIX trial (NCT04404660), which showed high 3-month complete response (CR) rates among patients who received obe-cel.

Park started off by pointing out the strong safety profile of obe-cel, especially in patients with high-burden disease. He also emphasized how data from real-world analyses of the CAR T-cell therapy are consistent with those reported in clinical trials.

Recently, a post hoc analysis of FELIX presented at the 52nd Annual Meeting of the European Society of Blood and Marrow Transplantation also showed favorable safety outcomes with obe-cel in ALL. Data from the analysis showed that patients with relapsed/refractory B-ALL who responded with obe-cel (n = 99) achieved a 0.7-month median time to neutrophil recovery to a level of at least 0.5 x 10⁹/L (95% CI, 0.49-0.92) and median time to a platelet count recovery of at least 50 x 10⁹/L (95% CI, 0.30-1.68).

Park noted that real-world studies have demonstrated low rates of cytokine release syndrome with obe-cel. In addition to low toxicity rates, Park added that real-world studies have indicated that obe-cel and other CAR T-cell therapies like brexucabtagene autoleucel (brexu-cel; Tecartus) are often used in earlier lines of therapy for patients. Park concluded by mentioning that the favorable safety profile of CAR T-cell therapies for ALL has allowed older patients to receive this treatment modality, a dynamic that was reflected in real-world data.