Press Release: Furmonertinib Being a First-line Drug to Treat Patients Suffering from Advanced NSCLC, with Progression-free Survival (PFS) of 20.8 Months
2022/03/23

It is anticipated that Furmonertinib will emerge as the preferred first-line therapy for EGFR-mutated advanced NSCLC.

 

Abstract

Just now, the European Lung Cancer Congress (ELCC) released the Abstract of findings from a phase-III registered clinical trial (FURLONG) of Furmonertinib Mesilate for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) sensitive mutations on its website. The Abstract showed that the median progression-free survival (PFS) was 20.8 months with Furmonertinib, which increased the longest PFS achieved with the current third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) alone as the first-line treatment of advanced NSCLC by 1.5 months, and which the risk of disease progression or death fell by a record 56%.

The FURLONG study was initiated by Shanghai Allist Pharmaceuticals Co., Ltd. (hereinafter referred to as "Allist"; stock code: 688578), and led by Professor Yuankai Shi from the Cancer Hospital Chinese Academy of Medical Sciences.

 

Main Findings

FURLONG is a phase III, randomized, double-blind, positive-controlled, multi-center study conducted in mainland China. Patients with locally advanced or metastatic NSCLC who had EGFR-sensitive mutations were randomized to receive either Furmonertinib or Gefitinib (Irresa®) as the first-line treatment.

The results of the study showed that the median PFS with Furmonertinib was significantly longer by 9.7 months than with Gefitinib (20.8 versus 11.1 months; hazard ratio [HR] 0.44 [95% confidence interval (CI) 0.34–0.58]; p<0.0001) and the risk of disease progression or death was reduced by 56%. Despite the longer duration of exposure, the incidence of grade ≥ 3 adverse events in the Furmonertinib group was lower than that seen in the Gefitinib group (11% versus 18%).

The breakthrough research findings from the FURLONG study provide further evidence that the first-line treatment with Furmonertinib could deliver more benefits to patients compared with first-generation EGFR TKI. Furmonertinib is the only third-generation EGFR TKI in a registered clinical trial. The trial achieved the primary endpoint of study, that is, PFS exceeding 20 months, and saw a 56% reduction in the risk of disease progression or death.

An in-depth talk on the results from the FURLONG study will be presented in the form of a "Proffered Paper session" at the European Lung Cancer Congress (ELCC) on March 31.


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FURLONG PI

Professor Yuankai Shi

National Cancer Center / Cancer Hospital Chinese Academy of Medical Sciences

Lung cancer is one of the malignant cancers with the highest morbidity and mortality in China while EGFR mutations are the most common driver mutations in lung cancer. There is still an unmet clinical need for the first-line treatment of NSCLC patients with EGFR gene-sensitive mutations. The results of the FURLONG study are encouraging. The first-line treatment with Furmonertinib achieved a median PFS of 20.8 months and demonstrated a favorable safety profile. It is a promising candidate for patients with locally advanced or metastatic NSCLC who had EGFR gene-sensitive mutations, offering a new and better first-line treatment option.

 

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Jinhao Du

Allist Chairman

Since Allist was established, it has shown commitment towards making a difference in the field of innovative drug research and development, pursuing its development goal of "advancing long life with innovation of science and technology", and providing benefits to the world from China. Furmonertinib is one of the innovative medicines developed by Allist in standing by this goal and is an innovative development in the field of oncology! The release of the data from the FURLONG study marks a milestone, signifying that more lung cancer patients will benefit from the treatment with Furmonertinib. Spurred on by this remarkable success, the team at Allist will continue to forge a path ahead and develop more breakthrough innovative drugs, which deliver good news to patients in China and right around the world.

 

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Sandy Mu

Allist CEO

Supported by excellent clinical data and benefits, Furmonertinib continues to deliver new breakthroughs in the field of anti-lung cancer treatment. FURLONG further demonstrates that Furmonertinib has excellent efficacy and safety profiles in the first-line treatment of EGFR-sensitive mutated NSCLC, laying a solid evidence-based medical foundation for the first-line application of Furmonertinib. We will further communicate with the regulatory authority to accelerate the approval of Furmonertinib for the treatment of first-line indication, in order to benefit more patients with EGFR mutation-positive advanced lung cancer.