Patient enrolment completed for fruquintinib’s Phase II study in non-small cell lung cancer

Development moving rapidly in four parallel studies in non-small cell lung cancer, colorectal cancer and gastric cancer

Shanghai: Friday, March 6, 2015: Hutchison MediPharma Limited (“HMP”) today announces that it has completed patient enrolment in a Phase II clinical trial of fruquintinib (HMPL-013) in non-small cell lung cancer (“NSCLC”) patients in China.  The proof-of-concept (“POC”) study is investigating the efficacy and safety of fruquintinib, HMP’s investigational small molecule inhibitor of vascular endothelial growth factor receptors (“VEGFR”).

This randomized, double-blind, placebo-controlled, multi-center, POC Phase II study is targeted at treating non-squamous NSCLC patients who have failed second-line standard chemotherapy.  A total of 91 patients have now been randomized to receive fruquintinib plus best supportive care (“BSC”) or placebo plus BSC at a 2:1 ratio. The primary endpoint is progression free survival, with secondary endpoints including disease control rate, overall response rate, overall survival and safety.  As a result of the rapid patient enrolment, data from this trial is expected in mid of 2015.

Fruquintinib is designed to selectively inhibit VEGF receptors, namely VEGFR1, VEGFR2, and VEGFR3. In the first-in-human Phase I clinical trial 40 patients were treated with fruquintinib. Detailed results of the Phase I clinical trial are available at http://chi-med.com/eng/irinfo/presentations.htm, and were presented at the annual meeting of the American Association for Cancer Research in April 2013.

Based on the Phase I data in colorectal cancer (“CRC”), a Phase Ib study was initiated which treated a further 62 CRC patients.  Detailed results of the Phase Ib clinical trial were presented at the annual meeting of the American Society of Clinical Oncology in May 2014, and also can be found at http://chi-med.com/eng/irinfo/presentations.htm.

In April 2014, HMP initiated the first POC Phase II study, which was a randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial targeted at patients with metastatic CRC.  The POC Phase II study subsequently completed enrolment in August 2014, and will report data during the first half of 2015.

In October 2014, HMP initiated a Phase Ib dose-finding study of fruquintinib, in combination with paclitaxel, in second line gastric cancer patients.

In December 2014, HMP initiated FRESCO, a Phase III registration study in patients with locally advanced or metastatic CRC, who have failed at least two prior systemic antineoplastic therapies, including flouropyrimidine, oxaliplatin and irinotecan.  FRESCO will enroll more than 400 patients in 25 centers in China, with top-line results expected in 2016.

In October 2013, HMP entered into a licensing, co-development and commercialization agreement in China with Eli Lilly and Company for fruquintinib.

 

About vascular endothelial growth factor (“VEGF”) and non-small cell lung cancer (“NSCLC”) in China

At an advanced stage, tumors secrete large amounts of VEGF, a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumor in order to provide greater blood flow, oxygen, and nutrients to the tumor.  VEGF and VEGF receptors (“VEGFRs”) play a pivotal role in tumor-related angiogenesis, and inhibition of the VEGF/VEGFR pathway.  This represents an exciting therapeutic strategy in blocking the development of new blood vessels essential for tumor to grow and invade.

Lung cancer is the most common cancer both worldwide and in China.  The American Cancer Society estimated that about 220,000 new cases of lung cancer were diagnosed in the United States each year.  In China, lung cancer is the most commonly diagnosed cancer, with over 715,000 cases in 2012, accounting for 18.7% incidence among all cancer patients.  It is also the most common cause of cancer death.  There are two major types of lung cancer: small cell lung cancer and NSCLC.  NSCLC is a disease in which malignant cancer cells form in the tissues of the lung, and can be further classified based on cancer cell types with the most common ones including squamous cell carcinoma, large cell carcinoma and adenocarcinoma.

To date, several anti-VEGF/VEGFR agents have shown clinical efficacy against a number of tumor types. Given the scale and growth in the China oncology market, the market for VEGF/VEGFR inhibitors in China is expected to develop quickly in the next few years.