NEW YORK – Ascentage Pharma on Tuesday said it has treated the first Philadelphia chromosome-positive acute lymphoblastic leukemia patient with the BCR-ABL1 tyrosine kinase inhibitor olverembatinib and chemotherapy in a Phase III trial.
Ascentage and Innovent Biologics jointly market olverembatinib in China as a treatment for TKI-resistant chronic-phase chronic myeloid leukemia or accelerated-phase CML harboring T315I mutations. In the latest registrational study, the drugmakers will compare olverembatinib and chemo against Novartis' earlier-generation TKI Gleevec (imatinib) and chemo in 350 patients with newly diagnosed Ph-positive ALL. Researchers will evaluate patients' minimal residual disease (MRD) negativity rate as the study's main endpoint.
Ascentage believes olverembatinib could have an advantage over first- and second-generation TKIs in improving complete molecular responses and inhibiting the T315I resistance mutation. If olverembatinib nets regulatory approval in China for Ph-positive ALL, it could be the first TKI approved for this indication in this region. The Chinese Society of Clinical Oncology has recommended the drug for Ph-positive ALL in its guidelines.
"Philadelphia chromosome-positive ALL used to be the most high-risk and difficult-to-treat subtype of leukemia, and the introduction of TKIs has resulted in improved prognosis to patients with this condition," Weili Zhao, the VP of Shanghai Jiaotong University School of Medicine-affiliated Ruijin Hospital and the director of Shanghai Institute of Hematology, said in a statement. "However, clinicians face the pressing question of which TKI offers the best efficacy and safety. We hope [this trial] can provide an answer to those important questions."
Olverembatinib has not secured regulatory approval outside China.