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On July 10, 2025, China’s National Medical Products Administration (NMPA) granted approval for lisaftoclax (APG-2575), a novel, oral, B-cell lymphoma 2 (BCL-2) inhibitor, for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received ≥1 systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.1
This approval is based on results from the registrational phase II APG2575CC201 trial (NCT05147467), which assessed the efficacy and safety of lisaftoclax monotherapy in patients with relapsed/refractory (R/R) CLL/SLL.1 The primary endpoint of overall response rate (ORR) was met in patients who were previously treated with a BTK inhibitor and/or immunochemotherapy.1 The safety profile was manageable, with no tumor lysis syndrome reported and low incidences of hematologic and non-hematologic toxicities.1
Lisaftoclax is currently under evaluation in four global phase III trials:
GLORA (NCT06104566): lisaftoclax in combination with BTK inhibitors for patients with CLL/SLL previously treated with a BTK inhibitor for >12 months with suboptimal response.
GLORA-2 (NCT06319456): lisaftoclax in combination with acalabrutinib vs immunochemotherapy in newly diagnosed patients with CLL/SLL.
GLORA-3 (NCT06389292): lisaftoclax in combination with azacitidine in newly diagnosed, elderly, and unfit patients with acute myeloid leukemia (AML).
GLORA-4 (NCT06641414): lisaftoclax in combination with azacitidine in newly diagnosed patients with higher-risk myelodysplastic syndromes (MDS).
References
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Which of the following would most increase your confidence in referring patients with R/R large B-cell lymphoma for CAR T-cell therapy?