The FDA had no major objections to LSKB’s global phase 3 pivotal-trial study design for apatinib in patients with advanced gastric cancer. The Company believes the plan to conduct a single phase 3 clinical trial will be sufficient to support an accelerated development pathway and NDA submission.
“We had a good, collaborative meeting with the U.S. FDA,” said Dr. Sung Chul Kim, President of LSK BioPharma, “we received valuable guidance that we expect will help us to quickly bring apatinib to market and provide a much needed therapy to support cancer patients worldwide.”
LSKB is now finalizing the global phase 3 pivotal trial-study design and expects to start as quickly as possible. The phase 3 design is a randomized placebo-controlled study examining the safety and efficacy of apatinib in advanced gastric cancer patients to be conducted in the U.S., Europe, Japan, Korea, and Taiwan.
About Apatinib
Apatinib is the first successful small-molecule angiogenesis inhibitor in gastric cancer. It has been approved in China (advanced gastric cancer, Dec 2014) by the Chinese-territory license-holder Jiangsu Hengrui. LSK BioPharma, which holds the global rights (ex-China), has completed phase 1/2a clinical studies under a U.S. FDA IND and is planning to initiate multiple late stage clinical trials in gastric cancer (global pivotal trial), colorectal cancer, and hepatocellular carcinoma.
LSKB has partnered development and marketing in Korea with Bukwang Pharma. Apatinib acts by inhibiting angiogenesis in solid tumors. Angiogenesis is a critical process in cancer growth and proliferation, as tumors cannot grow beyond 1-2mm3 without sufficient blood supply.
Apatinib acts by selectively inhibiting VEGFR-2 which is primarily responsible for tumor-mediated angiogenesis. Apatinib has been tested in almost 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, colorectal cancer, HCC, NSCLC, breast cancer, mesothelioma, and neuroendocrine tumors.