Zorifertinib Completes Last Patient Last Visit in International Multicenter Phase II/III Clinical Trial for NSCLC with CNS Metastases

ShanghaiAugust 25, 2022PR Newswire -- Alpha Biopharma, an innovative drug provider, recently announced that its Class 1 new drug "Zorifertinib," supported by the National Major New Drug Creation Special Project -- a next-generation EGFR-TKI specifically for treating advanced non-small cell lung cancer patients with central nervous system metastases, has successfully completed the last visit of the last subject in the international multicenter Phase II/III clinical study EVEREST. The top-level data from this clinical study is expected to be available by the end of 2022, at which time Alpha Biopharma will submit a New Drug Application (NDA) to the National Medical Products Administration (NMPA).

As the principal investigator of the EVEREST clinical trial and Chairman of the Chinese Thoracic Oncology Group (CTONG), Professor Wu Yilong stated: "The EVEREST study is a randomized, open-label, international multicenter Phase II/III clinical trial. It is also, to date, the world's only large-scale prospective international multicenter clinical trial specifically targeting EGFR mutation-positive non-small cell lung cancer patients with central nervous system metastases. The study was conducted across 55 research centers, including those in mainland China, Taiwan, South Korea, and Singapore, enrolling a total of 492 patients. Preclinical and early clinical data have demonstrated zorifertinib’s high blood-brain barrier permeability, its efficacy in treating non-small cell lung cancer with central nervous system metastases, overall therapeutic advantages, and safety profile consistent with EGFR-TKI drugs. This provides the potential for more and better treatment options for patients with brain metastases. Naming the study EVEREST (after Mount Everest) symbolizes the determination of innovative pharmaceutical companies and researchers to reach the pinnacle of science and address significant yet unmet clinical needs."

As the co-principal investigator of the EVEREST clinical trial and Director of the Department of Medical Oncology at the Cancer Hospital of the Chinese Academy of Medical Sciences, Professor Wang Jie stated: "Lung cancer with central nervous system metastasis has always been a challenging issue in clinical practice and a major cause of death for those patients. Zorifertinib is a potent next-generation EGFR-TKI targeting sensitive mutations in the EGFR gene, specifically the exon 19 deletion or L858R sensitive mutation, with good exposure in central nervous system lesions. Unlike all other TKI drugs, it is not a substrate for the blood-brain barrier endothelial cell transport proteins P-gp and BCRP, demonstrating complete blood-brain barrier penetration and maintaining high drug exposure in brain tissue and cerebrospinal fluid. The compound’s development process involved optimizing its physicochemical and biochemical properties to meet the requirements for central nervous system penetration, which has been demonstrated in this study and previous clinical trials. We look forward to obtaining positive data to provide much-needed treatment options for patients."

Moreover, Song Ruilin, Executive President of the China Pharmaceutical Innovation and Research Development Association, also stated: "Over the past three years, the COVID-19 pandemic in some regions of China has posed significant challenges to innovative pharmaceutical companies. Many clinical research centers have faced numerous issues such as regional lockdowns, transportation restrictions, staffing shortages, follow-up treatments for participants, medication distribution, and data collection. However, the clinical development team at Alpha Biopharma, together with the researchers, worked hand in hand to overcome these difficulties and fully achieved key task milestones in the study. They repeatedly communicated and explored human-centered solutions, ensuring uninterrupted treatment for participants while paying full attention to patient safety and the quality of trial data. On the occasion of the LPLV milestone of the EVEREST study, we extend our sincere respect to all involved personnel and wish Zoritini to successfully reach the NDA milestone, bringing new hope to patients with non-small cell lung cancer and central nervous system metastasis as soon as possible."