Alpha Biopharma Announces Completion of its EVEREST Phase II/III Clinical Study of Zorifertinib in Non-Small Cell Lung Cancer Patients with Central Nervous System Metastases

Zorifertinib is a next generation EGFR-TKI with full Blood Brain Barrier penetration targeting EGFRm+ NSCLC patients with CNS metastases Top-line data from the study are expected around the end of 2022 Alpha Biopharma, a developer of innovative drugs, announces the completion of last patient last visit (LPLV) in its international, multicenter EVEREST phase II/III clinical study of Zorifertinib, a next-generation EGFR-TKI, in first line patients with advanced EGFRm+ non-small cell lung cancer (NSCLC) with central nervous system (CNS) metastases. Topline data from this MRCT study are expected around the end of 2022, at which time Alpha Biopharma could submit a New Drug Application (NDA) to the National Medical Products Administration (NMPA). As the international leading principal investigator (PI) of EVEREST study, Professor Yilong Wu, President of the Chinese Thoracic Oncology Group (CTONG), 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 (BBB) 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." Professor Jie Wang, Director of Oncology Department of Cancer Hospital Chinese Academy of Medical Sciences, and co-leading PI of EVEREST study, 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." 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. They diligently communicated with study sites to come up with solutions, paid full attention to the safety of the subjects and the quality of the trial data while ensuring the uninterrupted treatment of the subjects. In recognizing this pivotal milestone of EVEREST study completion, we would like to express sincere respect for the efforts of all relevant personnel involved in the study and wish Zorifertinib a smooth NDA submission. We are a step closer to bringing new hope to patients with CNS metastases of EGFRm+ NSCLC." About Zorifertinib 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, such as NSCLC. 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. CNS metastases is common in EGFRm+ NSCLC patients and accompanied with poor prognosis of earlier disease progression, shorter survival, and lower quality of life. The BBB significantly increases the difficulty of drug penetration into CNS, which allows the CNS to be a refuge for lung cancer cells. Zorifertinib is a new-generation EGFR-TKI specifically designed to fully penetrate the BBB to target brain metastases. Zorifertinib is in late-stage clinical studies and has global intellectual property protection.

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