Professor Lu Shun led the first-line treatment of lung cancer, and the third-generation EGFR-TKI Ametinib phase 3 clinical trial reached the primary endpoint

▎ WuXi AppTec's content team reported that today (March 30), Hausen Pharmaceuticals announced that its third-generation EGFR-TKI ametinib (trade name: Amelox) was the first-line treatment for EGFR mutation-positive locally advanced or metastatic non- Positive results were obtained in the phase 3 study of small cell lung cancer (NSCLC), reaching the preset primary research endpoint.

Previously, Ametinib has been approved in China for the second-line treatment of EGFR T790M mutation-positive NSCLC patients.

Image source: 123RF Ametinib is a third-generation EGFR (epidermal growth factor receptor)-TKI (tyrosine kinase inhibitor) developed by Hausen Pharmaceuticals.

In March 2020, the drug was approved by the National Food and Drug Administration (NMPA) for the first time for the treatment of locally advanced or metastatic NSCLC patients who have been treated with EGFR-TKI and have a T790M mutation positive.
The third-generation EGFR-TKI made in China on the market.

This announcement is a phase 3 clinical study aimed at evaluating the efficacy of ametinib in the first-line treatment of EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer.

The main investigator of the study is Professor Lu Shun, the chairman of the Lung Cancer Professional Committee of the Chinese Anti-Cancer Association and the director of the Oncology Department of the Shanghai Thoracic Hospital Affiliated to Shanghai Jiao Tong University.

According to the press release, Ametinib achieved positive results in the Phase 3 clinical study and reached the preset primary study endpoint.

The specific research data of the experiment will be announced in subsequent academic conferences.

Professor Lu Shun said that this phase 3 clinical study of ametinib is the world's first phase 3 randomized controlled study for Chinese patients in a true sense.
The level of evidence is higher, the applicability to Chinese patients is stronger, and the data is worth looking forward to.
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The announcement of this result will help provide more options for the first-line treatment of lung cancer patients in China.

At the press conference for the Phase 3 clinical study of Ametinib, Academician Wang Guangji of China Pharmaceutical University stated that the announcement of the positive results of the Phase 3 clinical study of Ametinib is a major breakthrough in the field of targeted therapy for lung cancer in China and promotes the research and development of innovative drugs in China.
An important milestone in internationalization.

According to the press release, Hausen Pharmaceuticals is currently exploring many new indications for Ametinib, including targeted combination chemotherapy, targeted anti-vascular therapy, and so on.

In the field of lung cancer segmentation, researchers have carried out a number of registered clinical studies.

Professor Lu Shun said that it is expected that these research results will provide a more accurate basis for the "individualized" treatment of lung cancer patients.

Note: This article aims to introduce the progress of medical and health research, not to recommend treatment options.

If you need guidance on treatment plans, please go to a regular hospital for treatment.