At ASCO, Hutchison China MediTech Ltd (NASDAQ:HCM) presented detailed Phase III trial results for one of its leading assets, fruquintinib (third-line colorectal cancer). Full data from the China-based FRESCO study demonstrated statistically meaningful improvements in both overall and progression-free survival while reinforcing the safety profile of the drug (no liver toxicity). This is the first full Phase III data readout from HCM and further validates its strategy of creating next-generation selective tyrosine kinase inhibitors (TKIs). HCM’s (together with partner Lilly) NDA to the China FDA has been accepted (Lilly will pay HCM a $4.5m milestone payment) with a launch potentially now in 2018. We maintain our valuation of $2.7bn.
Fruquintinib: FRESCO data shine bright
At ASCO, HCM presented the full data package (Abstract 3508) from FRESCO, its Phase III, 416-patient trial evaluating fruquintinib (a selective inhibitor of VEGFR 1, 2 and 3) in patients with metastatic colorectal cancer (positive top-line data announced in March). It met all primary and secondary endpoints; notably, median overall survival was 9.30 months in the fruquintinib group vs 6.57 months in the placebo group, a clinically significant achievement in this hard-to-treat patient population. Data demonstrate that it has a narrow serious side effect profile, notably no reported liver toxicity, a major advantage over available TKIs such as Bayer’s Stivarga, which has a black box warning for liver toxicity. The most common serious AE reported on fruquintinib included clinically manageable hypertension.
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