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Alpha Biopharma held advisory board meeting for Zorifertinib in Shanghai

From PR Newswire2020-01-10

Launched ceremony of chemical name “Zorifertinib” for AZD3759 and naming of the study


Alpha Biopharma Inc. ("AlphaBio") launched ceremony for the naming of chemical name and study name for Zorifertinib (AZD3759), AlphaBio's lead product, in shanghai on January 3rd , 2020. The leading academic experts including Professor Yilong Wu (Life-long Director of Guangdong People's Hospital, Honorary Director of Guangdong Provincial Lung Cancer Research Institute and top expert in lung cancer field), Professor Jie Wang (Director of Oncology Department of Cancer Hospital of Chinese Academy of Medical Sciences and Vice Chairman of lung cancer committee of China Anti-Cancer Association), Professor Shun Lu (Director of Oncology Department of Chest Hospital Affiliated to Shanghai Jiaotong University and Chairman of Lung Cancer Committee of China Anti-Cancer Association), Professor Ying Cheng (Secretary of The Party Committee of Jilin Cancer Hospital, Vice President of China Society of Clinical Oncology and Chairman of Small Cell Lung Cancer Committee of CSCO), Professor Myung-Ju Ahn from Samsung Medical Center in South Korea and AlphaBio’s management team jointly attended the meeting.



AlphaBio is a clinical stage company focusing on research and development of innovative therapeutics for unmet medical needs. So far AlphaBio has established its strong clinical development team, developing optimized innovative drug development strategies. The Company's management team consists of experienced drug development experts with decades of experience in multinational companies including clinical operations, regulatory affairs and pharmaceutical marketing, which is supported by drug development experts with decades of experience in tumor therapy and medical research.


Zorifertinib (AZD3759), AlphaBio's lead product, is a new-generation small molecule tyrosine kinase inhibitor (TKI) targeted in epidermal growth factor receptor, which can 100% pass through the blood-brain barrier to achieve the consistency of drug concentration in blood, brain and cerebrospinal fluid. It is specifically designed to treat EGFR mutation positive non-small cell lung cancer (NSCLC) patients with central nervous system (CNS) metastases.


In recent years, the development of EGFR-TKI drugs has improved the survival time of NSCLC patients with EGFR mutation positive. However, the following problems of drug resistance and CNS metastasis (including brain metastasis and meningeal metastasis) have become the main causes of treatment failure. Data shows that with the prolongation of the survival time in EGFR mutation positive NSCLC patients, the number of cases with CNS metastasis increases gradually, which the incidence is about 50%. These patients usually have poor prognosis, serious neurological deterioration, poor quality of life, short life expectancy, etc.

Zorifertinib (AZD3759) has carried out a global phase I clinical BLOOM study for EGFR mutation positive NSCLC patients with CNS metastasis. The study included 67 NSCLC patients from 11 centers in four regions including Australia, South Korea, Taiwan area and the United States. The modified RECIST 1.1 standard was used to evaluate the intracranial efficacy, extracranial efficacy and overall efficacy. The results showed that Zorifertinib (AZD3759) had 100% blood-brain permeability in human body, which showed its effective inhibition of central nervous system metastasis and tolerable safety.


Based on the positive data obtained in phase I clinical study, Zorifertinib started the EVEREST (AZD3759-003) phase II/III study in April 2018. In October 2019, EVEREST study has successfully passed the safety data verification of IDMC (Independent Data Monitoring Committee) meeting (IDMC is composed of clinical medicine experts, clinical research experts, pharmacology experts and independent statisticians), which is suggested to continue the study. The study is now in the enrollment stage.


During the advisory board meeting, as PIs of EVEREST study, many well-known experts in the field of lung cancer had a lively discussion on the progress of EVEREST study and Zorifertinib's R&D strategy.


As the global leading PI of EVEREST study, at the beginning of the meeting, Professor Yilong Wu clarified the treatment consensus of EGFR mutation positive NSCLC with CNS metastasis: based on the results of BRIAN study, it has been confirmed that EGFR-TKI treatment is superior to whole brain radiotherapy for EGFR mutation positive NSCLC with CNS metastasis. We all agreed that we should first use EGFR-TKI for brain metastasis with EGFR mutation positive.


Professor Myung Ju Ahn, as the global leading PI of Zorifertinib's phase I BLOOM study as well as the leading PI of EVEREST study in South Korea, introduced the results of BLOOM study in the meeting. She said, “most EGFR-TKI drugs are the substrates of P-gp and BCRP. While Zorifertinib is the first new generation of EGFR-TKI drugs specially designed to fully (100%) pass through the blood-brain barrier. The efficacies of intracranial and extracranial lesions are good, with the similar adverse reactions to other EGFR-TKI drugs.”


As the PI of EVEREST study, Professor Shun Lu said, “the EVEREST study is actually a phase II /III study with a larger sample size as well as a randomized controlled study in brain metastasis. The significant value of the study is that it is the first head-to-head comparison between TKI drugs in patients with brain metastasis. As we all know that Zorifertinib has good brain permeability, the value of such randomized prospective clinical study is to determine the difference between TKI drugs and whether it can become the standard treatment for brain metastasis.”


Professor Jie Wang, the leading PI of EVEREST study in China, said, “This is a randomized, open, global phase II / III study involving 55 research centers. The purpose of this study is to compare the efficacy and safety of Zorifertinib as the first-line treatment with Gefitinib/Erlotinib in the treatment of EGFR mutation positive (L858R and / or exon 19del) advanced NSCLC with CNS metastasis. 432 patients are planned to be enrolled in the study with 55 research centers participated in the study around the world. Among them, 41 centers are in China mainland, 9 centers are in South Korea, 4 centers are in Taiwan area, and 1 center is in Singapore. This is also the largest prospective clinical study for EGFR gene mutation positive NSCLC patients with brain metastasis.”


Professor Ying Cheng, the PI of EVEREST study in China, said during the discussion session, “so far we have seen the better intracranial and extracranial efficacy of Zorifertinib, which is exciting. We look forward to final results of EVEREST study on Zorifertinib. In clinic, drug resistance with CNS metastasis after EGFR-TKI treatment, especially meningeal metastasis, are still the focus and challenging point. According to the mechanism of Zorifertinib, we hope to explore this field and solve the unmet treatment needs in the future.”


In the end, Professor Yilong Wu summarized and put forward the message to Zorifertinib, “EVEREST study on Zorifertinib is the only large-scale prospective clinical study that has been carried out specially for brain metastasis of lung cancer in the world. It is hoped that study can be completed as soon as possible, which turns dream into reality and provide a better option for the clinical treatment of brain metastasis of lung cancer.”


The AlphaBio has built a strong clinical development team with extensive China, US, Europe and Asia/Pac development expertise. Zorifertinib (AZD3759) is not only a national class 1.1 innovative drug, but also a ‘National and Technology Major Project’ in China. In the future, AlphaBio will continue to cooperate with multinational pharmaceutical companies and R&D institutions at home and abroad, continuing to develop innovative therapeutic drugs urgently needed in clinical practice and becoming a leading and reliable innovative drug provider in the world.