|The following article features coverage from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Click here to read more of Hematology Advisor‘s conference coverage.|
KTE-X19, a chimeric antigen receptor (CAR) T-cell therapy, shows promising clinical activity among heavily pretreated patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), according to research presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
KTE-X19 is an autologous anti-CD19 CAR T cell therapy that previously showed encouraging results in phase 1 study. For the phase 2 ZUMA-3 study (ClinicalTrials.gov Identifier: NCT02614066), researchers evaluated the safety and efficacy of the recommended phase 2 dose, which was determined to be 1 × 106 CAR T cells/kg.
Overall, as of September 2020, a total of 55 patients were enrolled and received the experimental therapy. All patients had more than 5% bone marrow blasts at baseline and a performance status of 0 or 1.
The median follow-up period was 16.4 months (range, 10.3-22.1). The median patient age was 40 years (range, 19-84), the median baseline BM blasts were 65%, and 47% of patients had received at least 3 prior therapies.
The overall complete response (CR)/CR with incomplete hematological recovery rate was 71% (56% CRs vs 15% CRs with incomplete hematological recovery). Ongoing responses were noted in 31% of patients with a response; the median duration of response was 12.8 months (95% CI: 8.7-not estimable). Among patients with a CR/CR with incomplete hematological recovery, the minimal residual disease rate was 97%.
Median relapse free survival was 14.2 months; median overall survival was not reached.
Grade 3 or worse adverse events (AEs) were noted in 95% of patients, the most common of which were anemia (49%) and neutropenia (49%). Grade 3 or worse cytokine release syndrome was noted in 24% of patients, and grade 3 or worse neurologic events were noted in 25% of patients.
A total of 2 patients had a grade 5 treatment-related AE (brain herniation and septic shock, respectively).
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Read more of Hematology Advisor’s coverage of the 2021 ASCO Annual Meeting by visiting the conference page.
Shah BD, Ghobadi A, Oluwole OO, et al. Phase 2 results of the ZUMA-3 study evaluating KTE-X19, an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, in adult patients (pts) with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). J Clin Oncol. 2021;39:(suppl 15; abstr 7002). doi:10.1200/JCO.2021.39.15_suppl.7002