The National Medical Products Administration (NMPA) has granted approval to China-based Alpha Biopharma’s zorifertinib, commercially known as Zorifer, for the treatment of first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation and central nervous system (CNS) metastases.
Zorifertinib: A Pioneering Drug for NSCLC with CNS Metastases
Zorifertinib is recognized as the world’s first drug to enter regulatory clinical trials specifically for advanced NSCLC patients with CNS metastases, achieving remarkable results. It stands out as the only EGFR tyrosine kinase inhibitor (EGFR-TKI) explicitly designed to bypass non-blood-brain barrier efflux proteins, allowing it to penetrate the blood-brain barrier completely.
EVEREST Trial Outcomes and Clinical Significance
The EVEREST trial, an international multi-center randomized controlled Phase III study for zorifertinib, demonstrated its superior ability to control intracranial lesions. The trial enrolled patients with more severe disease profiles, including those with EGFR L858R mutations or more than three intracranial lesions. Zorifertinib showed significant benefits in overall progression-free survival (PFS), with intracranial PFS reaching 17.9 months, and significantly reduced the risk of intracranial progression/death by 37% (P = 0.0018). Additionally, zorifertinib demonstrated consistent and significant benefits in subgroups of patients with intracranial symptoms, EGFR L858R mutations, and more than three intracranial lesions.-Fineline Info & Tech
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