Biopharmaceutical innovator Alpha Biopharma proudly announces that the National Medical Products Administration’s Center for Drug Evaluation (CDE) has accepted its New Drug Application (NDA) for Zorifertinib – a revolutionary next-generation EGFR-TKI designed to treat advanced EGFR-mutated non-small cell lung cancer (NSCLC) patients with central nervous system (CNS) metastases. If approved, Zorifertinib will be the first EGFR-TKI to be clinically tested in a prospective, controlled registration study for this particularly challenging patient population, thus providing much-needed new treatment options to those affected.
2020 saw a staggering 9.96 million cancer deaths worldwide, with lung cancer emerging as the deadliest form of the disease. Tragically, 1.8 million of these deaths were from lung cancers, which are notoriously difficult to treat due to their low CNS penetration rate. As a result, metastasized lung cancers to the CNS have become one of the leading causes of death for NSCLC patients.
Zorifertinib is a revolutionary EGFR-TKI that can target the most common sensitive EGFR mutations (exon 19 deletion and exon 21 L858R), and can even permeate the blood-brain barrier (BBB) for complete effectiveness. Its special formulation makes it impervious to the efflux transporters P-gp and BCRP, guaranteeing that it can reach and remain in the brain tissues and cerebrospinal fluid for long-lasting results.
The EVEREST study was an ambitious clinical trial, conducted over 55 sites in four countries and involving 492 patients, that sought to determine the efficacy and safety of Zorifertinib as a first-line treatment for advanced EGFR-mutated NSCLC patients with CNS metastases. Results from the trial showed that Zorifertinib reduced the risk of disease progression and patient deaths in the targeted population, and had a comparable safety profile to other approved EGFR-TKIs. The primary resistance mutation observed at the time of disease progression was the EGFR T790M mutation. With the last patient last visit (LPLV) completed in the third quarter of 2022, the EVEREST study has provided valuable insight into the potential of Zorifertinib to help fight this devastating form of cancer.
Professor Yilong Wu, President of the Chinese Thoracic Oncology Group (CTONG) and the leading principal investigator (PI) of the EVEREST study, expressed his excitement over the results of the study, showing that Zorifertinib provided consistent, statistically significant benefits to EGFR-mutated NSCLC patients with different levels of CNS metastasis. He noted that this promising treatment could provide a much-needed solution for these difficult-to-treat patients, emphasizing the importance of patient-centric, targeted precision approaches for addressing unmet medical needs.
After years of hard work and dedication, Alpha Biopharma is thrilled to see that pre-clinical and clinical data have proven that Zorifertinib is effective in controlling CNS and overall disease progression in even the most difficult-to-treat patients. We are eager to collaborate with regulatory agencies globally to make this breakthrough treatment option available to those in need.
Zorifertinib is an exciting, new, oral, and reversible inhibitor of mutated EGFR (Exon19Del and Exon21L858R). This drug has the potential to revolutionize the treatment of patients with NSCLC who have CNS metastases and EGFR-sensitizing mutations. It is capable of penetration through the blood-brain barrier, which is often a barrier to other treatments. Zorifertinib is currently under NDA submission and has global patent protection, opening up a world of possibilities for those suffering from this type of cancer.
About Alpha Biopharma
Alpha Biopharma is a late-stage biopharmaceutical company dedicated to creating life-changing therapies for cancers and other unmet medical needs. The Company recently submitted its first NDA for the small molecule drug Zorifertinib to treat advanced NSCLC patients with CNS metastases and EGFR sensitizing mutations. In collaboration with leading cell therapy company Wugen, Alpha Biopharma is developing cutting-edge therapies such as memory NK-cells and CAR-T cells to treat multiple blood and solid tumors as well as T-cell lymphomas. An innovative IIT clinical study testing memory NK cells in relapse and recurring AML patients has already been initiated. Backed by a highly experienced management team with expertise in pre-clinical development, pharmacology, medical sciences, clinical operations, and business development, Alpha Biopharma is committed to bringing its innovative treatments to the market and improving the quality of life for cancer patients.