LSK BioPharma Announces Preliminary Review of Top-Line Results from ANGEL Study
LSK BioPharma Announces Preliminary Review of Top-Line Results from ANGEL Study
SALT LAKE CITY, USA, June 27, 2019 –
LSK BioPharma (LSKB) has completed the unblinding and preliminary review of topline data from its ANGEL Study, a Phase III clinical trial for rivoceranib (apatinib) which enrolled 460 advanced or metastatic gastric cancer patients. While the rivoceranib arm did achieve better median overall survival (OS) compared with placebo, and a result comparable to other approved drugs in gastric cancer, the result was not statistically significant. Overall survival was the primary endpoint in the ANGEL study. Rivoceranib demonstrated a highly significant improvement in median progression-free survival (PFS), which was a secondary endpoint. Rivoceranib was also generally well tolerated and safety results were consistent with prior studies. LSKB will conduct analyses as additional data become available such as overall response rate (ORR) and time-to-progression, follow surviving patients, and keep an open dialogue with regulatory agencies to determine the appropriate path to approval for rivoceranib in this gastric cancer monotherapy indication. The Company plans to continue ongoing clinical development programs in other indications including, earlier lines of therapy for gastric cancer with combination therapy, colorectal cancer, and hepatocellular carcinoma.
About Rivoceranib (Apatinib)
Rivoceranib, also known as apatinib or Aitan® (brand name) in China, is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib is investigational outside of China including in the United States; and safety and efficacy have not been established. It 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.
LSKB, which holds the global rights (ex-China), has completed enrollment of 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 (apatinib) is currently listed in 260 clinical studies on www.clinicaltrials.gov with over 20,000 patients enrolled or planned to be enrolled in trials targeting numerous cancers including GC, colorectal cancer (CRC), HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to improve 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.
Rivoceranib was developed by Advenchen Laboratories in Southern California under the designation YN968D1. The compound was exclusively licensed to Hengrui in China (2005) and LSKB (2007) for rest of the world.
About LSK BioPharma
LSKB is a privately-held biopharmaceutical company with offices in Utah, California, and South Korea. LSKB specializes in the 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.
Contact:
Jenna Choi
Associate Manager, Corporate Strategy
jenna.choi@lskbiopharma.com
