Hutchison China MediTech said it is preparing to submit its anticancer drug fruquintinib (HMPL-013) to the China Food and Drug Administration on the back of positive topline data from the pivotal Phase III FRESCO study in patients with locally advanced or metastatic colorectal cancer (CRC). The placebo-controlled trial found that patients receiving fruquintinib therapy plus best supportive care demonstrated a clinically relevant, statistically significant increase in overall survival (OS), compared with patients receiving placebo plus best supportive care. Treatment with fruquintinib, a selective, small-molecule vascular endothelial growth factor receptor (VEGFR) inhibitor, was also associated with statistically significant improvements in progression-free survival.

Chi-Med is developing fruquintinib for the Chinese market in partnership with Eli Lilly. The Phase III FRESCO study, involved 416 CRC patients who had failed at least two prior chemotherapies, including fluoropyridine, oxaliplatin, and irinotecan. Full data from the study will be presented at a scientific meeting later in the year.

Simon To, chairman of Chi-Med, called the FRESCO trial data an important milestone for patients, for the company, and for Chinese innovation. “We believe this is one of the first home-grown, China-discovered and developed, mainstream innovations in the field of oncology to succeed in a pivotal Phase III registration trial. Well over a decade of effort and investment has now paid off with these compelling Phase III topline results. They reinforce fruquintinib’s potential to address major unmet clinical needs for patients in both China and around the world. They also open the way to our submitting a NDA on fruquintinib around the middle of this year.”

Kerry L. Blanchard, Ph.D., M.D., svp of China Medicines Development Unit and External Innovation of Eli Lilly China Drug Development, added, “We are pleased to be working with the innovative biopharmaceutical company Chi-Med on the development of fruquintinib. This relationship highlights our commitment to help build a vibrant innovation ecosystem in China, and we look forward to our further collaboration to bring this novel medicine to patients.”

Fruquintinib is being developed in parallel for treating lung and gastric cancers. A pivotal registrational fruquintinib study, FALUCA, is ongoing in China in patients with advanced nonsquamous non-small-cell lung cancer (NSCLC) who have failed two lines of systemic chemotherapy. Topline data are expected during 2018. In January, Chi-Med started a Phase II combination trial evaluating fruquintinib and Iressa® (gefitinib) as first-line therapy for patients with advanced or metastatic NSCLC.

A Phase I/II study with fruquintinib combined with paclitaxel has separately been completed in the gastric cancer indication. A pivotal Phase III registrational study in gastric cancer is expected to start during the first half of 2017.

Last month Chi-Med started a Phase II efficacy and safety study with the oral c-Met receptor tyrosine kinase inhibitor savolitinib in patients with locally advanced or metastatic pulmonary sarcomatoid carcinoma and Met gene alterations. The drug is being developed for certain cancer indications in partnership with AstraZeneca. Chi-Med and AstraZeneca presented data from a Phase II savolitinib study in patients with papillary renal cell carcinoma at the 2017 Genitourinary Cancers Symposium, Orlando, Florida in February. Also in February the firm started a first-in-human Phase I study with the small-molecule fibroblast growth factor receptor (FGFR) inhibitor HMPL-453 in patients with advanced or metastatic solid tumors who have failed or are unable to tolerate standard therapies, or for whom there is no standard therapy.

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