Phase 1 Trial of BCL-2 Inhibitor Lisaftoclax (APG-2575) in Chinese Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Other Non-Hodgkin Lymphomas.

What was studied

This early trial tested lisaftoclax, a new drug that blocks BCL-2. The patients were Chinese people whose cancer had returned or resisted treatment. The cancers were chronic lymphocytic leukemia and small lymphocytic lymphoma. Other non-Hodgkin lymphomas were also included. Patients took it by mouth in 28-day cycles. Doses were stepped up each day to lower the chance of tumor lysis syndrome. People who had resisted or recently had a BCL-2 drug were left out. The team looked at safety and early efficacy.

What they found

51 patients were enrolled. They included 14 with CLL/SLL. 13 had mantle cell lymphoma. 4 had marginal zone lymphoma. The maximum tolerated dose was not reached. No dose-limiting toxicity or tumor lysis syndrome was seen. Common side effects were anemia, neutropenia and thrombocytopenia. Antitumor activity was seen in each of these cancers. Complete responses occurred in CLL/SLL and mantle cell lymphoma. Median progression-free survival was 7.9 months for all patients. Median overall survival was not reached.

What it means for patients

The team says lisaftoclax has a manageable safety profile. They say it induces durable responses in relapsed or resistant CLL/SLL and non-Hodgkin lymphoma.

Why it is not certain yet

This was an early trial with 51 patients. There was no comparison group. Median overall survival was not reached. Some subgroups were small, such as 4 patients with marginal zone lymphoma. A phase 1 trial mainly tests safety.

Source

Phase 1 Trial of BCL-2 Inhibitor Lisaftoclax (APG-2575) in Chinese Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Other Non-Hodgkin Lymphomas.

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