Olverembatinib named ALL breakthrough therapy in China
Designation speeds treatment's development as add-on for Ph-positive ALL
China has granted breakthrough therapy designation to olverembatinib to be used with low-intensity chemotherapy as a first-line treatment for newly diagnosed people with Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL), a type of blood cancer.
The Center for Drug Evaluation of China’s National Medical Products Administration grants breakthrough therapy status to speed the development and review of new treatments for serious diseases for which preliminary evidence indicates advantages over available options.
“We are much encouraged to have olverembatinib’s clinical value once again recognized by the regulatory authority in China,” Yifan Zhai, MD, PhD, chief medical officer of Ascentage Pharma, said in a company press release. “This [breakthrough therapy designation] underscores the therapeutic potential and utility of olverembatinib in [Ph-positive] ALL.”
ALL is a fast-growing blood cancer that develops in the bone marrow and affects immature white blood cells. Some people with ALL are Philadelphia chromosome-positive (Ph-positive), meaning pieces of DNA on chromosome 9 and chromosome 22 swap places in a blood cell. This creates a new abnormal gene called BCR-ABL1, which encodes for a hybrid protein, like a tyrosine kinase signaling protein, that’s always active, causing the cell to divide uncontrollably.
Ph-positive leukemias can be treated with targeted therapies called tyrosine kinase inhibitors, or TKIs, which interfere with the abnormal tyrosine kinase protein and the multiplication of cancerous white blood cells.
Limitations of current treatments
Ph-positive ALL accounts for 20% to 30% of adult ALL cases in China. Although the adoption of TKIs has improved outcomes, the treatments still have limitations, including a high relapse rate, short disease-free survival, and poor overall outcomes. No TKI has been approved as a first-line treatment of Ph-positive ALL in China, representing an unmet medical need, the company said.
Olverembatinib (HQP1351), jointly marketed by Ascentage and Innovent Biologics, is a third-generation TKI approved in China for various forms of TKI-resistant chronic myeloid leukemia (CML), a type of slow-growing blood cancer also associated with BCR-ABL1.
It’s currently indicated for adults with TKI-resistant CML in the chronic phase (CML-CP) or the accelerated-phase CML harboring a mutation called T315I. Adults with CML-CP resistant or intolerant to first- and second-generation TKIs are also indicated.
China’s Center for Drug Evaluation approved a global registrational Phase 3 study to compare olverembatinib versus imatinib, a TKI sold as Gleevec, Imkeldi, and generics. It will be tested in combination with chemotherapy for patients with Ph-positive ALL who have yet to receive treatment. A registrational trial is designed to obtain sufficient data to support an approval application.
“Moving forward, we will strive to accelerate this clinical development program for olverembatinib and bring it to more patients as quickly as possible,” Zhai said.
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