Recently, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced that Allist independently developed a blockbuster third-generation EGFR inhibitorVormetinib mesylate tablets are once again proposed to be included in the breakthrough ** variety, Indications: Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)** with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
On October 30, 2023, the U.S. FDA granted Breakthrough Designation to Furmetinib for the treatment of advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations.
According to the Yaodu database search, it can be seen that Furmetinib mesylate tablets (trade name: Ifsa) were first approved for marketing in China in March 2021, and have been indicated for EGFR-sensitive mutations and T790M mutations in China, and both have been included in the Chinese National Medical Insurance Catalog. In the first three quarters of 2023, the sales of fumetinib were 134.8 billion yuan, an increase of 8300 million, a year-on-year increase of 160%, is expected to exceed 2 billion yuan for the whole year
At the 2023 World Conference on Lung Cancer (WCLC), the latest clinical data from the F**our study of non-small cell lung cancer with EGFR exon 20 insertion mutations were presented.
The F**OUR study is a nationally multicenter, randomized, open-label, Phase Ib clinical study in patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations who are randomized to receive different dose groups of furmetinib**. As of June 15, 2023, a total of 86 patients have been enrolled in the F**OUR study for safety analysis, and a total of 80 evaluable patients have been evaluated for efficacy analysis.
The results of IRC showed that the confirmed ORR of the treatment-naïve 240 mg group, the treatment-experienced 240 mg group, and the treatment-experienced 160 mg group were respectively. 5%；The median DOR was 152 months, 131 month, 97 months.
In the treatment-naïve 240 mg, treatment-experienced 240 mg, and 160 mg cohorts, respectively, there were 4% and 4% of patients who discontinued due to TRAE**. The incidence of grade 3 TRAEs was 13%, 29%, and 18% in the three cohorts, respectively. The safety profile of the 160 mg and 240 mg cohorts was consistent with that of the approved 80 mg dose. The most common drug-related adverse events included diarrhoea, anemia, and elevated liver enzymes, and no new safety signals were observed.
References
1.The official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration.
2.Allist's official website and announcements.
3.Yaodu Database.
4.2023WCLC丨Interpretation of the latest published data of Furmetinib.
**: Yakudu Daily
Original: Jiang Li