China-based Hutchison China Meditech (HutchMed, NASDAQ: HCM, HKG: 0013) has announced that the first subjects have been dosed in two separate Phase II regulatory studies. The first study is for the pipeline candidate HMPL-453, which is being assessed as a treatment for advanced intrahepatic cholangiocarcinoma with fibroblast growth factor receptor (FGFR) 2 fusion. The second Phase II study is focused on Orpathys (savolitinib) as a treatment for gastric cancer with mesenchymal-epithelial transition (MET) factor amplification.
HMPL-453: A Single-Arm, Multi-Center, Open-Label Study
The Phase II study for HMPL-453 is designed as a single-arm, multi-center, open-label study to assess the efficacy, safety, and pharmacokinetics of the molecule in advanced intrahepatic cholangiocarcinoma with FGFR 2 fusion. HMPL-453 is a novel, highly selective FGFR 1, 2, and 3 inhibitor, with global rights owned by HutchMed.
Orpathys: A Single-Arm, Multi-Center, Open Phase II Regulatory Study
The other Phase II regulatory study is a single-arm, multi-center, open Phase II study intended to assess the efficacy, safety, and tolerability of Orpathys in Gastric cancer and gastroesophageal junction (GEJ) adenocarcinoma with MET amplification.
Orpathys: A Potent, Highly Selective Oral MET Tyrosine Kinase Inhibitor
Orpathys is a potent, highly selective oral MET tyrosine kinase inhibitor approved in China to treat non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations following chemotherapy. The drug is currently being assessed in multiple indications in clinical trials, including lung cancer, kidney cancer, and gastric cancer, among others.-Fineline Info & Tech
