HK-based Hutchison China Meditech--or Chi-Med--has completed enrollment for the Phase III trial leg of its colorectal cancer therapy candidate fruquintinib, HMPL-013.
The China trial for HMPL-013 involved 416 patients who have locally advanced or metastatic disease and had received two previous rounds of treatment, according to a release from the company. The enrollment completion marks an important milestone for a biotech that listed on the Nasdaq in March, where it raised $101.25 million.
The candidate is currently also in studies as a therapy to treat non-small cell lung cancer as a small molecule drug with a low toxicity profile.
Earlier clinical work led to an $18 million milestone payment to Chi-Med from Eli Lilly ($LLY) in the second quarter of last year, and came as part of a 2013 licensing pact. The milestone payment was made after a positive first proof-of-concept study result for fruquintinib in colorectal cancer in China.
"Pursuant to the licensing, co-development, and commercialization agreement entered into by HMP and Lilly in October 2013, HMP will receive a US$10 million mCRC POC milestone," Chi-Med said in May 2015. "In addition, HMP will receive a total of US$8 million in reimbursements for costs associated with the planning and launch of the FRESCO Phase III mCRC registration study in China, as well as for the establishment of related clinical supply production facilities in Suzhou, Jiangsu province in China."
In that Phase II leg, the secondary efficacy endpoints, including objective response rate, disease control rate and overall survival, were still being monitored.
"While we wait for the FRESCO CRC data to mature over the balance of the year, we are focused on accelerating the ongoing Phase III FALUCA pivotal trial in non-small cell lung cancer, and launching additional studies of fruquintinib--including a Phase II study in gastric cancer in combination with paclitaxel--new studies in the U.S., and certain exploratory studies in combination with other oncology agents," Christian Hogg, CEO of Chi-Med, said in its latest update.
The biotech is also working on pushing on with its pipeline, which includes an open-label Phase II clinical trial in thyroid cancer with candidate HMPL-012, sulfatinib, in China, among other oncology efforts.
- here's the release from Chi-Med