Ascentage Pharma (6855.HK) announced today that the company has published the clinical research results of the company's original Class 1 new drug Olebatinib (trade name: Nerlik®; research and development code: HQP1351) for the treatment of succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) in the form of a mini oral presentation at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting.

The clinical data of this oral presentation showed that Olebatinib has sustained clinical efficacy in the treatment of SDH-deficient GIST. As of March 12, 2024, 6 of the 26 patients with SDH-deficient GIST enrolled achieved partial remission (PR), the objective response rate (ORR) was 23.1%, and the median progression-free survival (PFS) was 22 months. In addition, potential mechanism of action (MOA) studies have shown that orebactinib exerts anti-tumor activity by regulating multiple signaling pathways involved in angiogenesis, apoptosis, proliferation and survival.

Orebactinib is an original Class 1 new drug developed by Ascentage Pharma. It is an oral third-generation tyrosine kinase inhibitor (TKI) and the first third-generation BCR-ABL inhibitor to be launched in China. It has been approved for two indications, namely, the treatment of adult patients with chronic myeloid leukemia (CML) in chronic phase (-CP) and accelerated phase (-AP) with any TKI resistance and T315I mutation; and the treatment of adult patients with CML-CP who are resistant and/or intolerant to first- and second-generation TKIs. The commercialization of orebactinib in China is jointly undertaken by Ascentage Pharma and Innovent Biologics.

In addition to clinical development and application in the field of hematological tumors, clinical exploration of orebactinib in the field of GIST is also being carried out simultaneously. At present, this product has been included in the "breakthrough therapy product" by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of patients with SDH-deficient GIST who have previously received first-line treatment. Recently, Olebatinib has been approved by the CDE to conduct a registered Phase III clinical study for the treatment of patients with SDH-deficient GIST.

The ESMO Annual Meeting is one of the most authoritative and influential oncology academic conferences in the world, presenting the latest cutting-edge data and research results to clinicians, researchers, patients, etc. around the world.

Source: https://news.yaozh.com/archive/44216.html