Aivertinib Demonstrates Promising Efficacy and Safety in Chinese Patients with EGFR T790M-Positive NSCLC, Highlights from Astra BioPharma's IPO Prospectus

Arterial New Medicine (WeChat ID: biobeat1) has learned that on the morning of June 2, Chicago time, Abivertinib, China’s first independently developed third-generation EGFR-TKI by Hangzhou Acebright Pharmaceuticals Research Co., Ltd., made its debut at the 2019 ASCO Annual Meeting. The company presented clinical study results on the treatment of Chinese patients with EGFR-T790M mutation-positive non-small cell lung cancer (NSCLC), titled “Safety and efficacy of abivertinib, a third-generation EGFR tyrosine kinase inhibitor, in Chinese patients with EGFR-T790M positive non-small cell lung cancer.” This marks the second appearance of Abivertinib at the ASCO Annual Meeting.

Professor Wu Yilong at the Ivetinib Exhibit Area of the ASCO Annual Meeting

The lead institution for this clinical study is the clinical team at Guangdong Provincial People’s Hospital, led by Professor Wu Yilong. Participating clinical centers include Hunan Cancer Hospital, West China Hospital of Sichuan University, Beijing Cancer Hospital, and The First Affiliated Hospital of Zhejiang University School of Medicine, among a total of 17 institutions.

Among more than 200 subjects treated with the recommended dose of avitinib (300 mg twice daily), 90% exhibited clear shrinkage of target lesions, the objective response rate (ORR) was 52.2%, the disease control rate (DCR) was 88.0%, and the Kaplan-Meier estimated median duration of response (DOR) was 7.64 months. Safety data indicated that adverse events reported in subjects receiving avitinib were primarily Grade 1 or 2, with no drug-related Grade 5 adverse events observed; the main adverse events were similar to those associated with approved EGFR-TKIs. These clinical study results demonstrate that avitinib provides clear efficacy, as well as favorable safety and tolerability, in treated subjects.

Hangzhou Aceon Pharmaceutical Research Co., Ltd. was established in July 2010 and is located in Hangzhou, Zhejiang Province. Since its inception, Aceon has adhered to the philosophy of “original innovation rooted in China and oriented toward the global market.” In the field of innovative drug research and development, Aceon has independently developed multiple Class 1 new drugs approved for clinical trials by both China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA).

Avitinib Maleate is the first domestically developed third-generation EGFR-targeted novel drug for lung cancer, developed in parallel with international efforts. It is primarily indicated for the treatment of non-small cell lung cancer (NSCLC) with EGFR T790M mutation positivity. In September 2014, Avitinib received approval for clinical trials from both China’s CFDA and the U.S. FDA. On August 9, 2018, its New Drug Application was included in the priority review program by the National Medical Products Administration. Avitinib is also a key achievement of the National “Twelfth Five-Year” Major Special Project on New Drug Creation, and it was approved as a project under the National “Thirteenth Five-Year” Major Special Project in December 2018.

AC0058, another novel small-molecule targeted drug with a first-in-class mechanism originally developed by Acea Pharmaceuticals, is primarily indicated for the treatment of autoimmune diseases such as systemic lupus erythematosus (SLE) and rheumatoid arthritis. It received approval from the U.S. FDA to initiate clinical studies in late 2015, and its Phase II clinical trial was launched in the United States in November 2018. The drug obtained clinical trial approval from the China Food and Drug Administration (CFDA) in December 2016 and was included in the National “13th Five-Year” Major Science and Technology Project for Significant New Drug Development in 2017. Upon successful development, AC0058 will become the world’s first oral medication for the treatment of autoimmune diseases such as systemic lupus erythematosus.