SHANGHAI, China, Sept. 10, 2023 (GLOBE NEWSWIRE) -- 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).
Key Results
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.