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Today, Shanghai Allist Pharmaceuticals Co., Ltd. (stock code: 688578) announced that Furmonertinib had been approved by the National Medical Products Administration (NMPA) of China for use in the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion (19DEL) or exon 21 (L858R) substitution mutations.
After yielding exceptional efficacy and safety data from the phase III registered clinical trial FURLONG on Furmonertinib, the application for the first-line treatment indication of Furmonertinib was accepted by NMPA at the end of 2021. It was listed for breakthrough therapy and granted priority review. The indication for first-line treatment was approved only 6.5 months after submission, once again achieving "Allist speed"!
Furmonertinib is a new class 1 drug independently developed by Allist, whose characteristics include "potent activity against brain metastasis, excellent efficacy, good safety and wide therapeutic window". The approval for this new indication is based on the results of a phase III, national, multicenter, randomized control, double-blind, double-simulation, registered clinical trial (FURLONG). The study results showed that, compared to the control group for Gefitinib (Iressa®), the first-line treatment of advanced NSCLC patients with EGFR sensitive mutations using Furmonertinib significantly prolonged the disease progression-free survival (PFS, 20.8 months vs. 11.1 months) by 9.7 months and reduced the risk of disease progression or death by 56%, making it the first product to yield a PFS beyond 20 months in first-line treatment among the three generation of EGFR-TKIs. Despite the long exposure time, the incidence of grade ≥3 adverse reactions to Furmonertinib was lower than that in the control group (11% vs. 18%).
In the FURLONG study, Furmonertinib demonstrated superior efficacy and excellent safety and tolerance in treating Chinese patients, especially for lung cancer patients who developed central nervous system (CNS) metastases. Therefore, it has now become the new, preferred option for the first-line treatment of advanced NSCLC patients with EGFR-sensitive mutations in China.
Lung cancer is one of the malignant tumors with the highest incidence and mortality rates in China. EGFR mutations are the most common driver mutations for lung cancer. There is still a huge unmet need in the first-line treatment of advanced NSCLC patients with EGFR sensitive mutations. The approval of the new indication means a wider patient population covered by Furmonertinib such that more patients will be able to benefit from Furmonertinib treatment. Allist will also continue to drive the inclusion of first-line indications into the Catalogue of Drugs for Basic National Medical Insurance as soon as possible so that more lung cancer patients can benefit from this treatment.
In March 2021, Furmonertinib was approved for adult patients with locally advanced or metastatic NSCLC who experienced disease progression during or after prior treatment with EGFR tyrosine kinase inhibitors (TKI) and who were tested positive for the EGFR T790M mutation. After 9 months, the second-line treatment for NSCLC using Furmonertinib was included in the Catalogue of National Medical Insurance reimbursement. After 15.5 months, the indication for first-line treatment was approved! The considerable potential of Furmonertinib is being noticed as this drug, and as planned, gradually cements its place as the pillar for the treatment of EGFR-mutated NSCLC!
In the future, Allist will hasten the process of meeting clinical needs and fulfilling the mission and commitment of "innovation and care for life", so that effective Chinese drugs can bring superior treatment and optimal survival to patients in China.
The FURLONG study is a phase III, randomized, double-blind, positive-control, multicenter clinical study to compare the efficacy and safety of Furmonertinib Mesilate with Gefitinib in the first-line treatment of patients with EGFR-sensitive mutations in locally advanced or metastatic non-small cell lung cancer. A total of 358 advanced NSCLC patients with EGFR mutations were enrolled in 55 research centers in China to randomly receive first-line treatment with either Furmonertinib 80mg/d or Gefitinib 250mg/d until withdrawal due to disease progression or other reasons. The primary endpoint of the study was progression-free survival (PFS), and secondary endpoints included objective response rate (ORR), overall survival (OS), safety, etc.
The results of the FURLONG study were presented for the first time at the European Lung Cancer Congress (ELCC) 2022. There was a statistically significant improvement in the IRC-assessed median PFS of 20.8 (17.8–23.5) months in the Furmonertinib treatment group compared with 11.1 (9.7–12.5) months in the Gefitinib group, with a hazard ratio [HR] of 0.44 (95% CI 0.34–0.58, p< 0.0001). The risk of disease progression or death was reduced by 56%.
Furmonertinib was well tolerated and no new safety signals were observed. The incidence of grade 3–4 adverse reactions did not exceed 2%. The most common adverse reactions were increased ALT (28%), diarrhea (25%), increased AST (25%), and rash (17%). The incidence of rash and diarrhea was lower in the Furmonertinib treatment group than in the Gefitinib group, and the incidence of grade 3–4 rash and diarrhea was 2% and 0%, respectively.
The 2022 American Society of Clinical Oncology (ASCO) presented an analysis of data from the FURLONG study in a population with central nervous system (CNS) metastases at baseline. The median CNS PFS was 20.8 and 9.8 months (HR 0.40 [95% CI 0.23–0.71], p = 0.0011) in the CNS full analysis set (cFAS) in the Furmonertinib and Gefitinib treatment groups, respectively, and the risk of CNS disease progression or death was reduced by 60%.
The results of the FURLONG study were published as online full text on June 2, 2022 in The Lancet Respiratory Medicine (IF 102.642), the world's highest impact factor academic journal in respiratory medicine.
Furmonertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) developed in China with independent intellectual property rights. In March 2021, Furmonertinib was approved for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who had experienced disease progression during or after prior EGFR TKI therapy and who had been tested positive for the EGFR T790M mutation.
Shanghai Allist Pharmaceuticals Co., Ltd. was founded in March 2004 as an innovative pharmaceutical company focusing on the development, industrialization and marketing of new drugs in the field of tumor treatment, guided by the global demand in the pharmaceutical market. Under the development concept of “increasing longevity through innovation in science and technology”, Allist seeks to develop first-in-class and best-in-class medicines. After 18 years of unremitting efforts, Allist now possesses the comprehensive capability to continuously create new anti-tumor drugs with independent property rights that boast the best efficacy in the market.
On December 2, 2020, Shanghai Allist Pharmaceuticals Co., Ltd. was officially listed on the Shanghai Stock Exchange Science and Technology Innovation Board (stock code: 688578).