SHANGHAI, Jan. 29,
2023 /PRNewswire/ -- Alpha Biopharma, a developer of
innovative drugs, announces that the Center for Drug Evaluation
(CDE) of the National Medical Products Administration (NMPA) has
accepted its New Drug Application (NDA) for Zorifertinib, a
next-generation EGFR-TKI specially designed to treat advanced
EGFR-mutated non-small cell lung cancer (NSCLC) patients with
central nervous system (CNS) metastases. Zorifertinib is the first
EGFR-TKI to be tested in a prospective, controlled registration
clinical study for this difficult-to-treat patient population, and
if approved, it will bring a much-needed new treatment option for
these patients.
Data released by the International Agency for Research on Cancer
(IARC) of the World Health Organization (SHO) showed that there
were 9.96 million cancer deaths worldwide in 2020, and 1.8 million
deaths were from lung cancers, making it the most common cause of
cancer deaths. Due to the low CNS penetration rate of most current
lung cancer drugs, lung cancers metastasized to the CNS were poorly
controlled and have become one of the leading causes of NSCLC
patient deaths.
Zorifertinib is a next-generation EGFR-TKI targeting sensitive
EGFR mutations (exon 19 deletion and exon 21 L858R) designed for
complete blood-brain barrier (BBB) permeability. In addition,
Zorifertinib is not a substrate for the efflux transporters P-gp
and BCRP, which allows it to achieve and maintain effective drug
exposure in the brain tissues and the cerebrospinal fluid.
The EVEREST study was a multinational, multicenter, randomized,
open-label, controlled phase II/III clinical trial designed to
evaluate the efficacy and safety of Zorifertinib as a first-line
treatment for advanced EGFR-mutated NSCLC patients with CNS
metastases. The study was carried out in 55 study sites located in
the Chinese mainland, Taiwan,
South Korea, and Singapore, with a total enrollment of 492
patients. The last patient last visit (LPLV) of the EVEREST study
was completed in the third quarter of 2022. Results from the
EVEREST study demonstrated that Zorifertinib effectively reduced
the risk of disease progression and patient deaths in the target
patient population and showed significant efficacy in treating
metastatic lesions in the CNS. In addition, Zorifertinib's safety
profile is comparable to other approved EGFR-TKI's. The primary
resistance mutation at the time of disease progression is the EGFR
T790M mutation.
Professor Yilong Wu, President of
the Chinese Thoracic Oncology Group (CTONG) and the leading
principal investigator (PI) of the EVEREST study, said, "Clinical
results from this high-quality, controlled study demonstrated that
Zorifertinib provided consistent and statistically significant
benefits to EGFR-mutated NSCLC patients with different levels of
CNS metastasis. It could provide a much-needed new treatment option
for these difficult-to-treat patients. The development of
Zorifertinib represents a great example of a patient-centric,
targeted precision approach to address unmet medical needs.
Eric Zhang, CEO of Alpha
Biopharma, said, "after many years of dedicated research and
development, we are very pleased to witness that all pre-clinical
and clinical data have demonstrated that Zorifertinib can achieve
and maintain high CNS exposures, that it is safe, and it is
advantageous in controlling CNS and overall disease progression in
this difficult-to-treat population. We look forward to working
closely with the regulatory agencies around the world to bring this
innovative treatment option to patients in dire need.
About Zorifertinib
Zorifertinib is a potent, oral, reversible inhibitor of mutated
EGFR (Exon19Del and Exon21L858R). EGFR is widely expressed in human
epidermal and stromal cells and is highly expressed in various
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 are common in
EGFR-mutated NSCLC patients and are accompanied by a poor prognosis
of earlier disease progression, shorter survival, and lower quality
of life. The BBB significantly increases the difficulty of drug
penetration into the CNS, which allows the CNS to be a refuge for
lung cancer cells. Zorifertinib is a next-generation EGFR-TKI with
full blood-brain barrier penetration targeting advanced NSCLC
patients with CNS metastases and EGFR-sensitizing mutations.
Zorifertinib is currently under NDA submission and has global
patent protection.
About Alpha Biopharma
Alpha Biopharma is a late-stage biopharmaceutical company
focusing on developing new therapies for cancers and other unmet
medical needs. The Company has submitted its first NDA submission
for its small molecule drug Zorifertinib to treat advanced NSCLC
patients with CNS metastases and EGFR sensitizing mutations. In
addition, in partnership with leading cell therapy company Wugen,
Alpha Biopharma is developing memory NK-cells to treat multiple
blood and solid tumors and CAR-T cells to treat T-cell lymphomas.
It has initiated an IIT clinical study testing memory NK cells in
relapse and recurring AML patients. Alpha Biopharma has assembled
an experienced management team with solid capabilities in
pre-clinical development, pharmacology, medical sciences, clinical
operations, and business development to advance its innovative
treatment solutions to the market and improve life quality for
cancer patients and commercialization.
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SOURCE ALPHA BIOPHARMA