Hutchison China MediTech reports data from fruquintinib, paclitaxel trial
Hutchison China MediTech announced that data from the ongoing Phase I/II clinical trial of fruquintinib in combination with paclitaxel, or Taxol, in second-line patients with advanced gastric cancer will be presented at the 2017 Gastrointestinal Cancers Symposium. Giving an abstract of the trial results, the company stated that as of September 10, 2016, a total of 32 patients were enrolled and dosed with fruquintinib in combination with weekly paclitaxel. The recommended phase II dose of fruquintinib was determined to be 4mg daily. Two patients at 4mg experienced dose-limiting toxicity, both with febrile neutropenia. Grade 3 or 4 treatment emergent adverse events included neutropenia at 40.6% and leukopenia at 28.1%, with higher frequencies in the 4mg cohort as compared with lower doses. At steady state, fruquintinib drug exposure increased dose-proportionally and was within the same range as given as a single agent. Paclitaxel exposure at fruquintinib RP2D however, increased by approximately 30% as compared to that of single agent. Twenty eight of 32 patients were evaluable for tumor response, and of these, 10 patients achieved confirmed partial response -- objective response rate 35.7% -- and 9 patients experienced stable disease for at least 8 weeks -- disease control rate 67.9%.