CStone announces 1st dosed patient in China for advanced GIST trial

Leading biopharmaceutical expert CStone Pharmaceuticals has reportedly announced the first person in China to be dosed for the Phase I/II bridging trial of Avapritinib, discovered by Blueprint Medicines, a partner of CStone.

This China-based standalone study is a registrational bridging trial including studies of dose-escalation in Phase I and dose-expansion in Phase II, aimed at assessing the efficiency, safety and pharmacokinetics of Avapritinib in patients suffering from metastatic or uresectable GIST (gastrointestinal stromal tumors).

Patients involved in this study are mostly those suffering from PDGFRA D842V- driven GIST, second or third-line GIST or later GIST.

For the uninitiated, GIST is a type of sarcoma, usually found in the wall of the stomach or in the small intestine. GIST is usually detected among patients between 50-80 years of age. Nearly 90% of GIST cases are related to cell growth dysregulation caused by PDGFRA and KIT tyrosine kinases mutation. There are presently no effectual treatments for patients suffering from PDGFRA D842V- driven GIST.

Avapritinib is an orally administered highly selective and potent KIT and PDGFRA inhibitor. Preclinical studies from previously published studies have revealed that Avapritinib shows strong activity against GIST-related PDGFRA and KIT mutant kinases.

Chairman & CEO of CStone, Dr. Frank Jiang has reportedly commented that patients suffering from PDGFRA D842V kinases mutations still lack efficient care even as GIST incident rates continue to rise and expressed CStone’s commitment towards the evolution of ground-breaking therapies designed to fulfill urgent medical needs. He further stated CStone’s wish to follow in the footsteps of their partner Blueprint Medicines, who have submitted an NDA for Avapritinib in the US and an application for marketing authorization in the EU, by giving patients in Greater China access to this innovative precision therapy at the earliest.

CStone’s Chief Medical Officer, Dr. Jason Yang spoke about the data presented from their global Phase I Navigator study of Avapritinib, presented at the ASCO 2019 annual meeting, which showed an 86% objective response rate and promising tolerability in GIST patients with PDGFRA Exon 18 mutations.

Source Credit: http://www.cstonepharma.com/en/html/news/2196.html