Lilly, Chi-Med cancer drug hits phase 3 goals, eyes China NDA

A full breakdown of the results has yet to be posted, but the biotech is planning for a mid-2017 China NDA filing.

Hong Kong-based Hutchison China MediTech (Chi-Med) and U.S. Big Pharma partner Eli Lilly have seen their partnered med hit its primary endpoint of increasing overall survival in certain colorectal cancer patients, as the biotech gears up for a mid-2017 filing in China.

Exact details were a little thin on the ground, but Chi-Med posted positive top-line data this morning from its phase 3 pivotal registration test of VEGF inhibitor fruquintinib, in more than 400 patients in China, who had locally advanced or metastatic colorectal cancer.

These patients were far down the treatment pathway, having failed at least two prior chemotherapies, including fluoropyrimidine, oxaliplatin and irinotecan, with the med being used in a third-line setting.

The late-stage study hit its primary endpoint of showing a clinically meaningful and a statistically significant increase in overall survival (OS), in the intention-to-treat population of patients using fruquintinib added to best supportive care, when pitted against patients treated with placebo plus best supportive care.

Based on these results, Chi-Med said that it is “currently preparing to submit a new drug application for fruquintinib to the China Food and Drug Administration” in the coming months.

The biotech also said it saw a statistically significant improvement in progression-free survival (PFS), a key secondary endpoint, in the so-called Fresco trial.

Other secondary endpoints included objective response rate, disease control rate and duration of response, although no further details were given about whether the med hit these.

And the companies have not given a breakdown of how well it did on the OS and PFS measurements; that will come “at an upcoming scientific meeting in mid-2017,” according to the release.

Simon To, chairman of Chi-Med, said: “Well over a decade of effort and investment has now paid-off with these compelling phase 3 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 3 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.”

Chi-Med raised a $100 million IPO last year on the Nasdaq, and also has a tie-up with AstraZeneca and its cancer candidate savolitinib, and is one of the front-running new Chinese biotechs that is looking to make a global impact.

The biotech is also working on fruquintinib in a late-stage small cell lung cancer test, as well as in a midstage study that sees fruquintinib combined with AstraZeneca’s Iressa (gefitinib) in the first-line setting for patients with advanced or metastatic NSCLC.

Other studies are also on the cards and soon to be initiated, Chi-Med says, including a phase 3 study in gastric cancer in combination with paclitaxel in China, new studies in the U.S., and “certain exploratory studies in combination with other oncology agents.”

The biotech is also working on a series of other earlier candidates, including a treatment called HMPL-523 for blood cancers and rheumatoid arthritis—a potential rival for blockbuster drugs including AbbVie’s Humira (adalimumab) and Janssen’s Imbruvica (ibrutinib).