Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) announced that the National Medical Products Administration (NMPA) has approved a clinical trial for its furmonertinib, a third-generation epidermal growth factor receptor (EGFR) inhibitor, targeting exon 20 insertion mutated non-small cell lung cancer (NSCLC).
Drug Profile
Furmonertinib received conditional market approval from the NMPA in March 2021 for locally advanced or metastatic NSCLC with EGFR T790M mutation. The drug was included in the National Reimbursement Drug List (NRDL) in 2021 and gained full market approval for first-line treatment in June 2022.
Clinical Need
Exon 20 insertion mutations account for about 10% of EGFR-mutated NSCLC cases and are associated with poor prognosis due to resistance to current therapies. Currently, no approved treatments exist in China for this patient population.
Study Results
The Phase Ib FAVOUR study, presented at ESMO in September 2021, showed promising efficacy for furmonertinib. In 10 treatment-naïve patients, the objective response rate (ORR) was 60% (IRC assessment) and 70% (investigator assessment), with a 100% disease control rate. The drug demonstrated a favorable safety profile.-Fineline Info & Tech
