Hutchison China MediTech Ltd (NASDAQ:HCM) and partner Lilly announced positive, top-line pivotal phase III trial results for fruquintinib in 3rd line colorectal cancer. The China based FRESCO study evaluating 416 patients who had failed at least two prior chemotherapies in CRC demonstrated a clinically meaningful and statistically significant increase in both overall survival and progression-free survival compared to placebo. Consequently, HCM is preparing for a China NDA submission mid-2017; this represents the first China based oncology innovation to succeed at Phase III. We expect the full data to be presented at the 53rd American Society of Clinical Oncology Meeting (ASCO) 2 to 6 June 2017. Our valuation remains unchanged at $2.4bn.
FRESCO underpins TKI selectivity hypothesis
Per the press release, the FRESCO trial met all primary and secondary endpoints of overall survival and progression-free survival. Furthermore, the trial did not identify any new or unexpected safety issues. The positive top-line phase III data set highlights the selectivity hypothesis of HCM’s TKI pipeline; this is immensely positive for sentiment and we look forward to the full data set being presented mid-year (we anticipate at ASCO 2017 given the timing and potentially the strength of data). Once presented, we will provide further commentary on the extent of fruquintinib efficacy in CRC. HCM will submit a new drug application for fruquintinib to China FDA mid-2017, paving the way for a potential 2018 launch in China.
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