LSKB ANNOUNCES THAT THE ANGEL STUDY HAS REACHED ITS PRIMARY COMPLETION DATE
SALT LAKE CITY, USA, Feb 12, 2019 — LSK BioPharma (LSKB, Company) announced that it has reached the pre-specified number of events required for unblinding and analysis of the primary endpoint of overall survival in the ANGEL study, a global Phase III clinical trial, which is evaluating the safety and efficacy of rivoceranib (also known as apatinib) in patients with advanced or metastatic gastric cancer.
“Reaching the primary completion date in our global pivotal trial is an important milestone in the development of rivoceranib” said Scott Houston, Vice President of Clinical Development, “Outside of China, where apatinib is marketed, there is no small-molecule angiogenesis inhibitor approved for gastric cancer. We believe it will be the first such drug available for these patients worldwide.”
The Company, which has conducted pre-submission meetings with FDA and EMA in the last month, will now focus on completion of database lock activities and subsequent data analysis with an expectation that the top-line, unblinded safety and efficacy data will be reported in the middle of this year. LSKB further expects to complete preparations in the second half of this year for filing marketing authorizations applications in several territories worldwide, including the US.