Suzhou-based Ascentage Pharma (HKG: 6855) announced the publication of Phase I clinical study results for its Bcl-2 inhibitor lisaftoclax (APG-2575) in Chinese patients with recurrent / refractory non-Hodgkin lymphoma (r/r NHLs) at the European Hematology Association (EHA) congress 2022.
Clinical Trial Results
The results demonstrated that APG-2575 was well tolerated at doses up to 800mg/day, with no cases of tumor lysis syndrome (TLS) observed. The drug showed preliminary efficacy across various recurrent and refractory blood tumors, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and T-cell NHL.
Efficacy Details
Among 32 assessable patients, 4 achieved complete remission (CR) and 8 partial remission (PR). In 11 evaluable CLL patients, who had all received intensive prior treatment and most had at least one high-risk prognostic factor, 8 patients in the dose group above 200mg (inclusive) had an objective response rate (ORR) of 87.5%, including 3 CR and 4 PR. Among 6 assessable MCL patients, the ORR was 33.3% (including 1 CR). In 4 assessable MZL patients, the ORR was 50%. In 3 cases of evaluable T-cell NHL, the ORR was 33.3%.
Mechanism and Development
Lisaftoclax is being developed to treat a variety of hematologic malignancies by selectively blocking Bcl-2 to restore normal apoptosis in cancer cells. The drug has been approved for multiple Phase Ib/II clinical trials in the US, China, and Australia, and is the subject of multiple clinical studies in blood tumors.
Collaborations
In July this year, Ascentage formed a collaboration with Innovent Biologics Inc. (HKEX: 01801) to pair lisaftoclax with Innovent’s letaplimab (palbociclib) in a clinical trial for recurrent, locally advanced, or metastatic estrogen receptor-positive (ER+) human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In November 2021, Ascentage partnered with Pfizer to explore the combination of lisaftoclax with Ibrance (palbociclib) in HER2-negative breast cancer.-Fineline Info & Tech
