Safety and Tolerability Confirmed in Patients with Resistance and Relapse to Existing Drugs
Complete Remission (CR) Efficacy in Acute Myeloid Leukemia (AML) Patients
[Asia Economy Reporter Hyungsoo Park] CrystalGenomics announced on the 14th that it presented the interim results of the Phase 1a/b clinical trial of the blood cancer drug candidate ‘Luxptinib (CG-806)’ through a poster at the European Hematology Association (EHA 2021) on the 11th (local time).
The interim results of the Phase 1a/b dose-escalation trial of Luxptinib (CG-806), a non-dependent mutation 'BTK·FLT3' inhibitor, were disclosed for 22 patients with relapsed or refractory B-cell lymphoma who had relapsed and developed resistance after receiving at least two standard treatments or had no alternative treatments due to tolerance issues.
The primary objectives of the clinical trial were to evaluate the safety and tolerability of Luxptinib and to determine the optimal dose for Phase 2. Additionally, preliminary evidence of pharmacokinetics-pharmacodynamics and antitumor activity was assessed.
The clinical results showed good tolerability without safety issues at all doses administered orally twice daily (BID) ranging from 150mg to 600mg over multiple cycles.
In clinical trials targeting B-cell malignancies, Luxptinib strongly inhibited multiple key tumor targets (including BTK) and pathways that can target lymphocytosis occurring in chronic lymphocytic leukemia (CLL), and tumor size reduction was confirmed in various types of cancers.
In follicular lymphoma (FL) patients, a type of non-Hodgkin lymphoma, tumor size increased at a 450mg dose, but a dose-dependent efficacy was observed with a 43% reduction in tumor size from the peak when the dose was increased to 600mg, which is encouraging. At the 750mg dose, a decrease in IgM was confirmed in a patient with Waldenstr?m macroglobulinemia (WM), a rare type of blood cancer.
In the 750mg cohort, one dose-limiting toxicity (DLT) of hypertension occurred. After cohort expansion and detailed data analysis according to the clinical protocol, the side effect is expected to be unrelated to CG-806.
Luxptinib showed good tolerability overall across all cohorts and various cancer types, so it can be administered to patients with extensive prior treatment history who are difficult to treat through further dose escalation and long-term drug exposure in the future.
Currently, patients are being enrolled in the fifth cohort receiving 750mg for B-cell malignancy patients. If this 750mg dose level is confirmed to be safe, the dose will be increased up to the planned maximum dose level of 900mg.
Separately, a Phase 1a/b clinical trial targeting acute myeloid leukemia (AML) is also underway. A patient who received the first cohort dose of 450mg twice daily (BID) showed a complete response with complete tumor disappearance.
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
