The trial met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in overall survival (“OS”), in the intention-to-treat (ITT) population of patients treated with fruquintinib plus best supportive care (“BSC”) as compared to patients treated with placebo plus BSC.
Chi-Med is currently preparing to submit a new drug application (“NDA”) for fruquintinib to the China Food and Drug Administration.
In addition to OS, a statistically significant improvement in progression-free survival (“PFS”), a key secondary endpoint, was observed. The adverse events demonstrated in FRESCO did not identify any new or unexpected safety issues. Full detailed results are subject to ongoing analysis and are expected to be disclosed at an upcoming scientific meeting in mid-2017.
Chi-Med chairman Simon To said: “Well over a decade of effort and investment has now paid-off with these compelling Phase III top-line 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.”
“The success of the FRESCO trial is an important milestone not just for CRC patients and Chi-Med, but also for Chinese innovation.
“We believe this is one of the first home-grown, China-discovered and developed, mainstream innovation in the field of oncology to succeed in a pivotal Phase III registration trial. It shows that China has the resources, capability and perseverance to emerge as an innovator in the global oncology field.
“With eight small molecule drug candidates in over 30 clinical studies worldwide, Chi-Med is at the forefront of this important evolution.”
Eli Lilly and Company (“Lilly”) China Drug Development, China Medicines Development Unit and External Innovation and China Drug Development senior vice president Kerry Blanchard said: “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.”
In addition to the FRESCO colorectal cancer trial, fruquintinib is being studied in China in a Phase III pivotal trial in non-small cell lung cancer (“NSCLC”), known as FALUCA; and a Phase II study using fruquintinib combined with Iressa (gefitinib) in the first-line setting for patients with advanced or metastatic NSCLC.
Other studies currently being planned, and soon to be initiated, include a Phase III study in gastric cancer in combination with paclitaxel in China, new studies in the US, and certain exploratory studies in combination with other oncology agents.