Elevar Therapeutics announced data from the ANGEL trial, a randomized phase 3 study of rivoceranib (also known as apatinib) plus best supportive care in patients with gastric or gastroesophageal junction cancer who have failed at least 2 prior lines of therapy. This announcement and today’s podium presentation at the European Society for Medical Oncology’s (ESMO) 2019 Congress represent the first detailed public disclosure of ANGEL study data since the announcement of the topline results in June.
“This study demonstrates the potential of rivoceranib to treat patients with late-stage gastric cancer,” said Dr. Steven Norton, Elevar Therapeutics’ Vice President of Clinical Development, “this is the first multinational phase 3 study after rivoceranib’s approval in China. We look forward to further analyzing the data and believe that it will support our planned regulatory submissions.”
The ANGEL trial enrolled 460 patients total in 12 countries; 308 in the rivoceranib arm and 152 in the placebo arm. In the rivoceranib arm, 186 were 3rd line while 122 were ≥4th line (a pre-specified stratification factor). In the placebo arm, 89 patients were 3rd line while 63 were ≥4th line.
The median overall survival (mOS) of the full (3rd line and ≥4th line) intention-to-treat (ITT) population was 5.8 months for the rivoceranib group versus 5.1 months for the placebo arm, a result that did not reach statistical significance (p=0.485). However, the mOS in the ≥4th line was positive and significant (p=0.0195), with a mOS result of 6.3 months for the rivoceranib arm versus 4.7 months for the placebo arm. The median progression free survival (mPFS) of the full population (3rd and ≥4th line) was also positive at 2.8 months for the rivoceranib arm versus 1.8 months for the placebo arm, a result that was highly significant (p<0.0001). The mPFS for the ≥4th line was also positive and highly significant (p<0.0001) at 3.5 months for the rivoceranib arm versus 1.7 months for the placebo arm.
The objective response rate in patients randomized with measurable disease was about 7% and the disease control rate was 42%, in alignment to what was observed in the Phase 3 Chinese study that supported the market approval in China. As expected, rivoceranib was generally well tolerated in the ANGEL study with a manageable safety profile.
The full set of data presented at ESMO on September 29, 2019 can be found at:
About Rivoceranib (Apatinib)
Rivoceranib is the first successful 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. Elevar Therapeutics holds the global rights (ex-China). The Company has completed a global (12 countries across Asia, US, and Europe) Phase 3 clinical trial of rivoceranib in advanced or metastatic gastric/gastroesophageal junction cancer patients (“ANGEL study”). Elevar Therapeutics is also developing rivoceranib for the treatment of patients with earlier lines of gastric cancer, colorectal cancer, hepatocellular carcinoma, and adenoid cystic carcinoma. 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. Elevar Therapeutics 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. The Company plans to meet with US FDA on October 24, 2019 to receive advice on regulatory submissions for monotherapy gastric cancer treatment.
About Elevar Therapeutics
Elevar Therapeutics (formerly LSK BioPharma) is a privately held biopharmaceutical company with offices in Utah, California, and South Korea. The Company aims to provide patients and their caregivers with exceptional choices for effective and well-tolerated therapies. Elevar Therapeutics’ lead proprietary drug candidate is rivoceranib, a selective VEGFR-2 inhibitor which has demonstrated clinical efficacy in a variety of solid tumors. Elevar Therapeutics can be found on the web at www.elevartherapeutics.com.
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.