Alpha Biopharma announces completion of phase 2/3 clinical study for drug to treat lung cancer

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Patients with advanced EGFRm+ non-small cell lung cancer (NSCLC) with central nervous system (CNS) metastases have completed their last visit in a clinical trial studying the drug, Zorifertinib.

Drugs developer, Alpha Biopharma, announced the completion today (August 25) of last patient last visit (LPLV) in its international, multicenter EVEREST phase 2/3 study of the next-generation EGFR-TKI.

Topline data from this study are expected around the end of 2022, at which time Alpha Biopharma could submit a new drug application to the National Medical Products Administration (NMPA).


Professor Yilong Wu, president of the Chinese Thoracic Oncology Group, said: “EVEREST study is an international, multicenter, phase II/III randomized clinical study. It is also the only large-scale prospective international multicenter clinical study worldwide for first line EGFRm+ NSCLC patients with CNS metastases to date.

“It was carried out in 55 study sites located in Chinese mainland, Taiwan, South Korea, and Singapore, with a total enrollment of 492 patients. The clinical and preclinical data of Zorifertinib have shown its high blood-brain barrier penetration, anti-tumor activity in metastatic CNS lesions, overall efficacy in both CNS and extra-cranial diseases, and similar safety profile as other EGFR-TKI drugs.

“If approved, it is expected to provide a valuable choice for treatment of EGFRm+ NSCLC patients with CNS metastases. As the name EVEREST suggests, the study sponsor and investigators are dedicated to solving important unmet clinical needs.”

Potent inhibitor

Zorifertinib is a potent, oral, reversible inhibitor of the tyrosine kinase activity of the epidermal growth factor receptor (EGFR-TKI) activating mutation (L858R and Exon19Del). EGFR is widely expressed in human epidermal cells and stromal cells and is highly expressed in a variety of human malignancies.

EGFR gene mutation will cause excessive epidermal growth factor receptors on the cell membrane surface, accelerate the abnormal growth and division of cells, and eventually lead to tumorigenesis.

Professor Jie Wang, director of Oncology Department of Cancer Hospital Chinese Academy of Medical Sciences said: “Lung cancer with CNS metastases has always been a challenging problem and leading cause of death for these patients.

“Zorifertinib is a next-generation, high-potent EGFR-TKI drug targeting sensitive mutations of exon 19 deletion or L858R in EGFR gene with good exposure in CNS lesions. It is not a substrate of efflux transporter P-gp and BCRP, thus not only capable of fully passing through BBB, but also maintaining high drug exposure in the brain tissue and cerebrospinal fluid. 

“It was intentionally designed to optimize its physicochemical and biochemical properties meet the requirements of CNS penetration, which has been proven to be the case in this and prior clinical studies. We look forward to the finale data readout and if positive, a direly needed treatment for these patients.”

Alpha Biopharma new therapies

Alpha Biopharma is a late-stage biopharmaceutical company focused on developing potential new therapies for cancer’s unmet medical need. Founded in 2017, the company has advanced Zorifertinib to its Phase 2/3 trial to treat NSCLC patients with brain metastases. 

Dr. Ruilin Song, executive president of China Pharmaceutical Innovation and Research Development Association, said: “In the past three years, the COVID-19 pandemic in some regions of China has brought great challenges to innovative biotech companies.

“Many clinical study sites faced challenges in terms of regional lockdown, logistics, and clinical operations. However, the clinical development team at Alpha Biopharma and investigators worked together to overcome difficulties to achieve the key milestones of the EVEREST study.”

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