Suzhou-based Ascentage Pharma (HKG: 6855) has presented the latest results of multiple studies regarding its innovative drug candidate olverembatinib at the 65th American Society of Hematology (ASH) annual meeting. The data highlights the potential of olverembatinib in treating various hematological malignancies, including chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic leukemia (Ph+ALL).
Phase II Study in CML-CP Patients
A randomized controlled, regulatory Phase II study showed significant improvement in event-free survival for CML-CP patients resistant to first- or second-generation tyrosine kinase inhibitor (TKI) therapy when treated with olverembatinib (mEFS: 21.22 months vs 2.86 months) compared to the best available therapy (BAT), with a favorable safety and tolerability profile.
Phase II Clinical Trial for Ph+ALL
In a Phase II clinical trial combining olverembatinib with venetoclax and low-intensity chemotherapy for newly diagnosed Ph+ALL, all patients achieved complete remission (CR) at the end of the first cycle, with no TLS or treatment-related deaths. Preliminary data indicate the combination’s safety and effectiveness for initial treatment of Ph+ALL patients.
Efficacy and Tolerability in Advanced CML and Ph+ALL
Previous studies have demonstrated olverembatinib’s excellent efficacy and tolerability in patients with advanced treatment/refractory CML and Ph+ALL, either as a monotherapy or in combination with the bispecific CD19-targeted antibody blinatumomab. It can overcome resistance to ponatinib and/or asciminib, unaffected by T315I mutations.
MVHO Regimen in Refractory or Relapsed AML in Children
A series of case studies on the combination of liposome mitoxantrone, venetoclax, homoharringtonine, and olverembatinib (MVHO regimen) in children with refractory or relapsed AML showed an 83.3% total response rate and good tolerability, suggesting its potential as a first-line strategy for AML.
Regulatory Approvals and Partnerships
Olverembatinib, a third-generation BCR-ABL TKI, received conditional market approval in China on November 25, 2021, for use in chronic phase and accelerated phase (CP/AP) CML with T315I mutation resistant to other TKI treatments. It obtained priority review status in July 2022 for CP CML patients resistant or intolerant to first- and second-generation TKIs. In May 2023, the drug was awarded BTD status for the treatment of succinate dehydrogenase (SDH) deficient gastrointestinal stromal tumors (GIST) that have undergone first-line treatment.
Ascentage entered into a USD 245 million licensing deal with Innovent Biologics Inc. (HKG: 1801) in July 2021, granting co-development and co-commercialization rights to olverembatinib and other drugs in Greater China. Ascentage also partnered with Sinopharm in November 2021 to strengthen the commercial layout for the drug.-Fineline Info & Tech
