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Novel TKI Under Study in T315I-Mutated Chronic-Phase CML

By: Julia Fiederlein
Posted: Tuesday, January 5, 2021

According to Qian Jiang, MD, of Peking University People’s Hospital, Beijing, China, and colleagues, olverembatinib (HQP1351) seems to be safe and active in patients with T315I-mutated chronic-phase chronic myeloid leukemia (CML). The multicenter phase II HQP1351-CC201 trial results were presented during the virtual edition of the 2020 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 651).

“Olverembatinib is an orally active third-generation BCR-ABL tyrosine kinase inhibitor designed for the treatment of patients with CML harboring a T315I mutation,” the investigators commented. In this trial, a total of 41 patients with tyrosine kinase inhibitor (TKI)-resistant disease were administered 40 mg of olverembatinib once every other day for 28 consecutive days per cycle over 24 months. Follow-up data were provided for a median of 7.9 months.

The mean progression-free survival rates were 100.0% and 96.7% at 3 and 6 months, respectively. A total of 31 patients did not have a complete hematologic response at baseline; however, 96.8% of this population achieved a complete hematologic response after treatment. In the patients who did not have a complete cytogenetic response at baseline, a major cytogenetic response rate of 75.6% was observed; this included those with complete (65.9%) and partial (9.8%) cytogenetic responses. Major molecular responses occurred in 48.8% of patients.

Thrombocytopenia (all grades: 65.9%; grade 3 to 4: 48.8%), anemia (48.8%; 24.4%), leukopenia (46.3%; 12.2%), and neutropenia (36.6%; 19.5%) were among the most frequently reported treatment-related adverse events. The most common nonhematologic treatment-related adverse events were skin pigmentation (53.7%) and elevations in creatine kinase (48.8%), alanine transaminase (31.7%), and aspartate transaminase (26.8%). No treatment-related deaths were reported.

Disclosure: For full disclosures of the study authors, visit ash.confex.com.



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