On March 9, 2020 Elevar Therapeutics, a late stage biopharmaceutical company focused on promising therapies for unmet medical needs in cancer, reported the initiation of a pivotal trial for the treatment of adenoid cystic cancer (ACC) with the enrollment of the first patient at the University of California, San Francisco Division of Hematology and Oncology (Press release, LSK BioPharma, MAR 9, 2020, View Source [SID1234555331]). This study is designed to evaluate the efficacy and safety of rivoceranib in subjects with recurrent or metastatic ACC of all anatomic sites of origin. Chief Drug Development Officer, Dr. Steven Norton, said, "The opportunity to study the impact Rivoceranib has on ACC could lead to a shift in the way ACC patients are treated. We recognize the high unmet need for these patients and are committed to advancing care for these patients."
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Adenoid cystic carcinoma (ACC) is a relatively uncommon tumor with a reported 1,200 new cases diagnosed each year in the United States. Elevar is preparing to file for orphan drug designation (fewer than 200,000 patients) in the United States. ACC is considered a low-grade malignancy, and is characterized by slow growth and invasion of the tumor to the space surrounding nerves. ACC typically occurs in salivary glands, but can also occur in secretory glands located in other tissues such as the esophagus, breast and lungs. Although good local control is usually achieved by resection of the primary tumor and adjuvant radiation therapy, more than half of patients eventually have recurrent and/or metastatic disease. There is no standard of care treatment option for ACC, and there is an unmet need for patients with recurrent and/or metastatic ACC.
Dr. Hyunseok Kang, Associate Professor of Clinical Medicine at University California, San Francisco, said, "Adenoid cystic cancer has been a very challenging disease with no standard treatment options other than repeated surgeries and/or radiation. We are glad to dose our first patient with Rivoceranib, which seems to be a very promising approach for these patients. Based on data we have seen out of China, I am optimistic that Rivoceranib would be proved to be a valuable treatment option for patients suffering advanced ACC."
The primary endpoint for this study is the frequency of patients with partial or complete responses to treatment (objective response rate). Secondary objectives include Overall Survival, Progression Free Survival, Duration of Response and Time to Progression. The study is being conducted at multiple centers across the United States and South Korea. Additional information can be found at ClinicalTrials.gov (Identifier: NCT04119453).
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 is in discussions with the FDA to receive advice on regulatory submissions for monotherapy gastric cancer treatment.