September 10th, 2023, Shanghai 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 locally advanced or metastatic non-small cell lung cancer (NSCLC) patients 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 overall response rate (cORR) was 78.6% in the treatment-naïve patients who received 240 mg daily of furmonertinib, and 46.2% in previously treated patients who received furmonertinib at 240 mg daily, and 38.5% in previously treated patients who received furmonertinib at 160 mg dose. The median duration of response (DoR) were 15.2 months, 13.1 months, and 9.7 months in the treatment-naïve with 240 mg, previously treated with 240 mg, and previously treated with 160 mg patient groups, respectively. Anti-tumor responses observed across near-loop, far-loop and helical EGFR Exon 20 insertion mutations.

Furmonertinib showed a well-tolerated safety profile. 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 groups, respectively. The safety profile of furmonertinib in the 160 mg and 240 mg dose groups in FAVOUR study is consistent with that of approved dosage (80 mg) of furmonertinib for classical mutations in China. The most common treatment related adverse events include diarrhea, anemia, and liver enzyme elevation.

Based on above FAVOUR study, furmonertinib has shown promising anti-tumor activities, 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 registration phase III study to compare Furmonertinib to platinum-based chemotherapy for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations (FURVENT/ NCT05607550 / CTR20231409). The trial is currently in the progress of enrollment at multiple regions such as US, China, Japan, France, etc. 

Shanghai Pulmonary Hospital

Dr. Baohui Han

EGFR exon 20 insertion mutation is the third largest mutation subtype of EGFR mutations, following exon 19 deletions and exon 21 L858R point mutations. It has limited treatment options; thus, the space for clinical development and improvement is large. With unique structural advantages, Furmonertinib, a self-developed third-generation of EGFR-TKI approved in China, has excellent efficacy and safety against EGFR-sensitive mutations and drug-resistant mutations (T790M). It also shows good anti-tumor activity and tolerability in EGFR exon 20 insertion mutations. In accordance with a series of data release in clinical trials, it may become the standard treatment option for this group of patients and bring new benefits to the them!

Vice Chairman of Shanghai Allist Pharmaceuticals

Jie Hu

Furmonertinib is a self-developed third-generation of EGFR TKI, which has pharmacological advantages including "dual activity, dual brain-penetrance, and well-managed safety". It covers NSCLC patients with EGFR-sensitive mutations, T790M mutations and other EGFR atypical mutations. FAVOUR study re-confirmed the promising efficacy and excellent safety profile of furmonertinib in NSCLC patients with EGFR 20 exon insertion mutations near-loop and far-loop. Phase III registrational trial of treating naïve patients with locally advanced or metastatic NSCLC in EGFR exon 20 insertion mutations with furmonertinib is currently ongoing in China, United States, Japan, Netherlands, France, and other places across the globe. The approval will lead to a better treatment option for patients worldwide and create more values for both Allist and ArriVent. Allist has been deeply engaged in oncology treatment field, and has the capability of both R&D and commercialization of innovative drugs to meet the unmet needs.