LSKB Announces Completion of Enrollment for the ANGEL Study of Rivoceranib (Apatinib) in Gastric Cancer
SALT LAKE CITY, USA, Oct 29th, 2018 — LSK BioPharma (LSKB, Company) announced that it has completed patient enrollment in its pivotal Phase 3 trial, ANGEL, which is evaluating the efficacy and safety of rivoceranib plus Best Supportive Care (BSC) compared to placebo plus BSC in patients with advanced or metastatic gastric cancer. The ANGEL study is designed to support approval by the U.S Food and Drug Administration (FDA), the European Medicines Agency (EMA), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Korean Ministry of Food and Drug Safety (MFDS) and Taiwan Food and Drug Administration (TFDA).
“Completion of enrollment in the ANGEL study is an important achievement and a critical milestone for our gastric cancer program and we appreciate all of the support from patients and investigators in accomplishing this global development milestone” said Dr. Sung Chul Kim, LSKB President, “Although rivoceranib has been approved in China, there is still no oral small-molecule angiogenesis inhibitor approved outside of China for gastric cancer. We believe it will be the first such drug for these patients worldwide.”
The Company will now focus on follow-up of enrolled patients and preparation of the data for analysis with an expectation that the top-line, unblinded efficacy and safety data will be reported in the second half of 2019. The Company further expects to submit a New Drug Application for rivoceranib with the FDA in late 2019.
About the ANGEL Study
The ANGEL study is a prospective, randomized, double-blinded, placebo-controlled, multinational, multicenter, parallel-group, phase III study to evaluate the efficacy and safety of rivoceranib plus Best Supportive Care (BSC) compared to placebo plus BSC in patients with advanced or metastatic gastric cancer. A total of 459 patients have been randomized in the ANGEL study in 12 countries (in USA, EU, EEC, Japan, Korea and Taiwan). Details of the ANGEL Study can be found at the following link: https://clinicaltrials.gov/ct2/show/NCT03042611
About Rivoceranib (Apatinib)
Rivoceranib is the first successful oral small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. It was approved in China (advanced gastric cancer, Dec 2014) where it is marketed by the Chinese-territory license-holder Jiangsu Hengrui Medicine Co., Ltd. LSK BioPharma holds the global rights (ex-China). The Company is currently conducting a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) Phase 3 clinical trial of rivoceranib in advanced or metastatic gastric cancer patients. Rivoceranib has been clinically tested in over 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, CRC, HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to significantly improve clinical outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea.
About LSK BioPharma
LSKB is a privately-held biopharmaceutical company with offices in Utah, California, and South Korea. The Company specializes in clinical development of promising targeted therapies for unmet medical needs in cancer. LSKB’s lead proprietary drug candidates is rivoceranib, a selective VEGFR-2 inhibitor which has demonstrated clinical efficacy in a variety of solid tumors. LSKB can be found on the web at www.lskbiopharma.com.