China-based CStone Pharmaceuticals (HKG: 2616) has published the results of the China-based bridging NAVIGATOR study for its Ayvakit (avapritinib), a tyrosine kinase inhibitor used to treat gastrointestinal stromal tumors (GIST), on the Oncologist website. The open-label, multi-center Phase I/II study was designed to assess the safety, pharmacokinetics, and anti-tumor efficacy of the drug in unresectable or metastatic GIST.
Study Results and Drug Profile
The results showed that Ayvakit demonstrated excellent and long-lasting anti-tumor activity in GIST patients carrying the PDGFRA D842V mutation in China, and good anti-tumor activity in fourth-line and above GIST patients. Ayvakit is a KIT and PDGFRA-targeted tyrosine kinase inhibitor in-licensed from the US firm Blueprint Medicine in June 2018. The drug won its first China indication for unresectable or metastatic GIST with PDGFRA exon 18 mutation (including PDGFRA D842V mutation) in March last year and was launched onto the market in under 30 days from approval.
Market Presence and Future Prospects
With marketing approvals in mainland China, Hong Kong, and Taiwan, Ayvakit is included in over 80 urban Huiminbao programs. The publication of the NAVIGATOR study results further highlights CStone Pharmaceuticals’ commitment to advancing innovative therapies for gastrointestinal stromal tumors and improving patient outcomes.-Fineline Info & Tech