Preliminary results of a bridding study of Chinese anti-tumor targeting drug Apotony were published.

On September 24th, at the 2020 Annual Meeting of the Chinese Clinical Oncology Association (CSCO), Keystone Pharmaceuticals announced the positive results of the China Phase I/II Bridge Study of the anti-tumor drug Apotony tablets.
Gastrointestinal mesothelioma (GIST) is a soft tissue sarcoma (sarcoma that mainly comes from mesolete tissue) in the gastrointestinal tract, which originates from Cajal mesothelioma cells in the gastrointestinal wall and most commonly occurs in the stomach and small intestine, a rare mesolete-derived tumor. The annual incidence of gastrointestinal mesothelioma is about 10-20%, no gender difference, good in people over 40 years of age.
Apotheni is a kinase inhibitor that the U.S. Food and Drug Administration (FDA) has approved for sale under the trade name AYVAKIT for the treatment of non-removable or metastasis GIST adult patients carrying the PDGFRA gene 18 exon mutation, including the PDGFRA D842V mutation.
However, the drug has not yet been approved in China, and the bridging study is an open-label, multi-center Phase I/II clinical study designed to assess the safety, pharmacodynamic characteristics and anti-tumor efficacy of Apothetic therapy for patients with non-removable or metastasis advanced GIST. The recommended dose (RP2D) of Phase II clinical studies was determined based on the preliminary results of the Phase I dose climbing study.
As of March 31, 2020, a total of 50 Chinese patients were included in the safety assessment of Apotony, 8 patients with D842V mutations, and 23 patients with 4L-plus patients were assessed for efficacy assessment based on the solid tumor efficacy evaluation standard 1.1 (RECIST).
that Apotony showed significant anti-tumor activity in patients with PDGFRA D842V mutations. The overall tolerance is good.
Lin, Associate Dean, Oncology Hospital, Peking University, said: "Due to the extremely limited benefits of existing therapies, GIST patients with the PDGFRA D842V mutation have a high degree of unsolved treatment needs. Apotony showed very good anti-tumor activity and good safety and tolerance in patients with late-stage GIST in China with PDGFRA exon 18 mutation. As a clinician, I am pleased to see that GIST treatment has entered the era of precision targeting, and look forward to the early approval of Apotheni as a new treatment option for this group of GIST patients. Dr
Jianxin Yang, Chief Medical Officer of
Keystone Pharmaceuticals, said: "We are pleased to announce the results of the GIST Precision Targeting Drug Apotony Phase I/II Preliminary Bridge Study in Group Chinese at the CSCO meeting. Studies have shown good tolerance among Chinese patients and demonstrated strong anti-tumor activity in Chinese patients with PDGFRA exon 18 D842V mutations. We look forward to the early benefit of Apotony to Chinese patients. "
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