China-based Ascentage Pharma (HKG: 6855) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a pivotal regulatory Phase III clinical study. The study will evaluate the combination of its Category 1 drug, olverembatinib, with chemotherapy in newly diagnosed Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) patients.
Understanding the Clinical Urgency of Ph+ ALL
Ph+ ALL is characterized by a high recurrence rate, short disease-free survival time, and poor prognosis. Hematopoietic stem cell transplantation is considered the first line of treatment for Ph+ ALL patients. However, more than 70% of Ph+ ALL patients experience pre-transplant recurrence or do not have transplant opportunities, indicating an urgent need for improved treatment plans.
Olverembatinib’s Third-Generation BCR-ABL TKI Profile
Olverembatinib, a third-generation BCR-ABL tyrosine kinase inhibitor (TKI), was conditionally approved in China on November 25, 2021, for use in chronic phase and accelerated phase chronic myeloid leukemia (CML CP/AP) with T315I mutation that is resistant to other TKI treatments. In July 2022, it received priority review status for the indication of chronic phase (CP) CML patients resistant to or intolerant of first- and second-generation TKIs. In May 2023, the drug was awarded breakthrough therapy designation for the treatment of succinate dehydrogenase (SDH) deficient gastrointestinal stromal tumors (GIST) that have undergone first-line treatment.
Ascentage Pharma’s Partnerships for Olverembatinib
In July 2021, Innovent Biologics Inc. (HKG: 1801) entered into a USD 245 million licensing agreement with Ascentage, securing co-development and co-commercialization rights to olverembatinib and other drugs in Greater China. In November 2021, Ascentage teamed up with Sinopharm to strengthen the commercial strategy for the drug, further expanding its reach and potential impact in the region.-Fineline Info & Tech
