Allist Pharmaceuticals Co., Ltd. (“Allist”) and ArriVent Biopharma, Inc. (“ArriVent”) together announced that interim results from the Phase Ib, randomized, open-label, multi-center clinical study (FAVOUR), evaluating the efficacy and safety of furmonertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, were presented by Professor Baohui Han from Shanghai Chest Hospital during an oral session on September 10, 2023 at the 2023 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC).
As of the data cutoff date of June 15, 2023, a total of 86 patients were enrolled in the FAVOUR study and were included in the safety analysis; 80 evaluable patients were analyzed for efficacy. Based on IRC assessments, the confirmed objective response rate (cORR) was 78.6% in the treatment-naïve patients who received furmonertinib at 240 mg daily dose, 46.2% in previously treated patients who received furmonertinib at 240 mg daily dose, and 38.5% in previously treated patients who received furmonertinib at 160 mg daily dose. The median duration of response were 15.2 months, 13.1 months, and 9.7 months in the treatment-naïve 240 mg, previously treated 240 mg, and previously treated 160 mg patient groups, respectively. Anti-tumor responses were observed across near-loop, far-loop and helical EGFR exon 20 insertion mutations.
A well-tolerated safety profile has been observed to-date in the FAVOUR study. Most of the treatment-related adverse events (TRAEs) were Grades 1 and 2. TRAEs leading to treatment discontinuation occurred in 0%, 4%, and 4% of patients in the 240 mg treatment-naïve, 240 mg previously treated, and 160 mg previously treated patient groups, respectively. The safety profile of furmonertinib in the FAVOUR study is overall consistent with that of approved dosage (80 mg) of furmonertinib in China for patients with advanced NSCLC with classical EGFR mutations with no new safety findings. The most common treatment related adverse events include diarrhea, anemia, and liver enzyme elevation.
Based on the FAVOUR study results, furmonertinib has shown promising anti-tumor activity as a single agent, good tolerability, and a manageable safety profile in treatment naïve and previously treated patients with advanced NSCLC who have EGFR exon 20 insertion mutations. Allist and ArriVent are currently collaborating on a global registrational Phase III study to compare furmonertinib to platinum-based chemotherapy for patients with locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations (FURVENT, NCT05607550 / CTR20231409). The trial is currently enrolling patient in the US, China and other countries.
Furmonertinib is a novel, oral, highly brain-penetrant, EGFR kinase inhibitor designed for broad activity and selectivity across EGFR mutations.
Furmonertinib targets both classical (exon 19 deletion and L858R) and uncommon EGFR mutations, including exon 20 insertion mutations as well as HER2 exon 20 insertion mutations. Furmonertinib is approved in China as an anticancer therapy for first-line treatment for classical EGFR mutant NSCLC patients and EGFR T790M NSCLC patients. Furmonertinib is being developed in China by Allist Pharmaceuticals and in the rest of the world by ArriVent Biopharma.
Shanghai Allist Pharmaceuticals Co., Ltd is co-founded by Mr. Du Jinhao, a renowned entrepreneur, and Dr. Guo Jianhui, tenured scientist of The United States National Institutes of Health (NIH). Headquartered in Zhangjiang Hi-Tech Park since its founding in March 2004, Allist has built itself into an innovative pharmaceutical company, discovering, developing, manufacturing and commercializing innovative medicines.
Under the development concept of “advancing long life with innovation of science and technology”, it is oriented by the unmet clinical demands in the global pharmaceutical market, with special focus on tumor treatment. Allist seeks to develop first-in-class and best-in-class medicines with uncompromised devotion to produce safe, effective, and inclusive innovative drugs with independent intellectual property rights.
After the A and A+ rounds of financing in 2019, Allist was formally listed on the Sci-Tech Innovation Board (STAR) market via the Shanghai Stock Exchange on December 2, 2020 (Stock code: 688578).
ArriVent is dedicated to accelerating the global development of innovative biopharmaceutical products. With a deep and global network, ArriVent seeks to access unique and best-in-class drug candidates at various development stages, including those coming from China and other emerging biotech hubs. Through strategic collaborations with innovative biopharma companies, ArriVent aims to globalize medicines for patients with unmet medical need in a broad range of diseases, with an initial focus in oncology.
For additional information, visit www.arrivent.com.