Dr. Shah on Results of ZUMA-3 Study for ALL

Bijal Shah, MD, associate professor, Department of Malignant Hematology, Moffitt Cancer Center, discusses the results of the phase I/II ZUMA-3 study, which looked at using KTE-X19, an anti-CD19 CAR T-cell therapy, to treat patients with relapsed/refractory acute lymphoblastic leukemia (ALL).

Currently, 5-year survival rates for patients with ALL are in the range of 5% to 10%, according to Shah. There is an unmet need for additional novel therapies, which led to the introduction of KTE-X19. The therapy is unique because physicians will sort the leukemia cells out, pulling only the T-cells into the manufacturing.

Thus far, the ZUMA-3 trial has treated 45 patients with relapsed/refractory ALL with KTE-X19. Thirty patients (66%) had ≥3 prior therapies. Of the overall 45 patients, 6, 23, and 16 patients received 2, 1, and 0.5 × 10⁶ cells/kg, respectively. All 41 patients who had ≥2 months of follow-up, the overall response rate was 68%. Of 19 pts with ≥2 of follow-up who were treated with 1 × 10⁶ cells/kg, the complete response (CR) or CR with incomplete hematology recovery rate was 84% and the median event-free survival was 15 months.