On June 29, 2022, Shanghai Acebright Pharmaceutical Technology Co., Ltd. (Stock Code: 688578) announced that Furmonertinib Mesylate (trade name: Afuresertib) had been approved by the National Medical Products Administration (NMPA) of China for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletion (19DEL) or exon 21 (L858R) substitution mutations.
Rationale for the Approval of the New Indication
Based on the outstanding efficacy and safety data from the FURLONG study, a Phase III pivotal clinical trial for Afuresertib in first-line treatment, the new indication application for Afuresertib was accepted by the NMPA at the end of 2021. The drug was also designated as a breakthrough therapy and granted priority review status. It took only 6.5 months from the submission of the first-line treatment indication application to its official approval.
Afuresertib is a Class 1 innovative drug independently developed by Acebright, featuring potent efficacy against brain metastases, superior overall efficacy, favorable safety profile and a wide therapeutic window. The approval of this new indication is based on the results of the FURLONG study, a national, multicenter, randomized, controlled, double-blind, double-dummy Phase III pivotal clinical trial.
The exceptional efficacy of Afuresertib observed in the FURLONG study for Chinese patients, especially those with lung cancer complicated by central nervous system (CNS) metastases, together with its excellent safety and tolerability, supports it as a new preferred option for the first-line treatment of Chinese patients with advanced NSCLC harboring sensitive EGFR mutations.
About Lung Cancer
Lung cancer is one of the malignant tumors with the highest incidence and mortality rates in China. EGFR mutation is the most common driver gene mutation in lung cancer, and there remains a huge unmet medical need in the first-line treatment of advanced NSCLC patients with sensitive EGFR mutations. The approval of the new indication means that the patient population eligible for Afuresertib treatment has been further expanded, enabling more patients to benefit from Afuresertib. Acebright will also actively promote the inclusion of the first-line treatment indication in the National Medical Insurance Catalog to benefit more lung cancer patients.
About the FURLONG Study
The FURLONG study is a randomized, double-blind, positive-controlled, multicenter Phase III clinical trial designed to compare the efficacy and safety of furmonertinib mesylate with gefitinib as first-line treatments for patients with locally advanced or metastatic NSCLC harboring sensitive EGFR mutations. The study was conducted at 55 research centers in China, enrolling a total of 358 patients with advanced EGFR-mutant NSCLC. These patients were randomly assigned to receive either furmonertinib 80 mg once daily or gefitinib 250 mg once daily as first-line therapy until disease progression or withdrawal for other reasons. The primary endpoint of the study is progression-free survival (PFS), and the secondary endpoints include objective response rate (ORR), overall survival (OS) and safety, among others.
About Afuresertib
Afuresertib is a third-generation EGFR tyrosine kinase inhibitor (TKI) independently developed in China with independent intellectual property rights. In March 2021, Afuresertib was approved in China for the treatment of adult patients with locally advanced or metastatic NSCLC who have experienced disease progression during or after prior EGFR TKI treatment and are confirmed to have EGFR T790M mutation-positive status upon testing.
