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Today (November 20th)), the official website of China's National Medical Products Administration (NMPA) has recently announced,Approval has been granted for the marketing of Zorifertinib Hydrochloride Tablets (brand name: Zerunni), a Class 1 innovative drug submitted by Alpha Biopharma. This medication is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, accompanied by central nervous system (CNS) metastases, offering a new treatment option for patients.
Screenshot source:NMPA Official WebsiteNSCLC accounts for approximately 80%-85% of all lung cancers, with the most common driver mutation being the epidermal growth factor receptor (EGFR) Gene mutation.CNS TransMove isEGFRMutation PositiveNSCLCCommon Metastatic Sites in Patients.Due to the blood-brain barrier increasing the difficulty of drug penetration into the brain, the cranium becomes a "sanctuary" for lung cancer cells.。Zolitinib（zorifertinib）YesMorningAlpha BiopharmaIntroduced by AstraZenecaA reversibleNew GenerationEpidermal Growth Factor Receptor Activation Mutation (L858RAndExon 19Del）Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI)，Specifically designed for the treatment of CNS metastasesEGFRDesigned for patients with sensitive mutations in advanced NSCLC,With the full ability to penetrate the blood-brain barrier。In Phase 1 and Phase 2 clinical studies,ZolitinibShowed good systemic and intracranial antitumor activity. According to literature reports[5]，Preclinical studies have found that,ZolitinibAfter administration, the drug can reach the same concentration in blood, cerebrospinal fluid, and brain tissue, proving that this product can 100% cross the blood-brain barrier.
According to an earlier press release from Alpha Biopharma, the new drug marketing application approval for Zolitinib was based on a targetedWith CNS metastasisEGFRNSCLC Patients with Sensitizing MutationsRandomized, Open-label, International Multicenter Phase 2/3EVEREST StudyResults.TheStudy EnrollmentEGFRSensitive mutations, untreated, no radiotherapy, with or without neurological symptoms, advanced non-small cell lung cancer with CNS metastasesPatient.Patients were randomly assigned in a 1:1 ratio to receive either Zoritini or a first-generation EGFR-TKI (Control group) treatment.The primary endpoint was progression-free survival (PFS) assessed by blinded independent central review (BICR) based on RECIST 1.1 criteria.October this year,CELLSub-journalMEDPublished in the magazineLatest results from the EVEREST study show,Compared with the control group, the median PFS of Zolitinib was significantly longer (9.6 months vs 6.9 months).Compared with the control group, zoritini significantly prolonged intracranial PFS. Overall survival (OS) is not yet mature;60% of patients in the Zoritini group can subsequently receive sequential third-generation EGFR-TKI treatment.In these patients, the estimated median OS for Zolitinib was 37.3 months (over 3 years).The safety profile of Zorifertinib is consistent with its previously reported data.
Researchers believe that, compared with the first-generation EGFR-TKI, zoritini significantly improved overall and intracranial PFS; adverse reactions were controllable. The sequential treatment of zoritini with the third-generation EGFR-TKI showed potential in extending patients' OS. The research results support zoritini as a treatment for patients with CNS metastases.EGFRA novel, well-validated first-line treatment option for patients with mutant non-small cell lung cancer.
It is hoped that the approval of Zolitinib in China will bring new treatment options to more patients with non-small cell lung cancer.[1] China's National Medical Products Administration Approves Zolitinib Hydrochloride Tablets for Marketing. from https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20241120155846111.html[2] Alpha Biopharma's Zoritini, the world's first Class 1 new drug, has been officially accepted for marketing application by the CDE. Retrieved Jan 30, 2023, from https://mp.weixin.qq.com/s/9SUiAxe7XN1r5wUR44O5UA?poc_token=HCOiBGejveab9_cMxcOIE-JyEdW9Bl6a8xcR0LQ6[3] Alpha Biopharma to Present EVEREST Study Data on AZD3759 for EGFR Mutation-Positive NSCLC with Brain Metastases at 2023 ASCO. Retrieved Jun 6, 2023, from https://mp.weixin.qq.com/s/cLAV4Q7oN5zXOgMrPnUz9g[4]Randomized phase 3 study of first-line AZD3759 (zorifertinib) versus gefitinib or erlotinib in EGFR-mutant (EGFRm+) non–small-cell lung cancer (NSCLC) with central nervous system (CNS) metastasis. From https://meetings.asco.org/abstracts-presentations/218106[5]Si-Yang Maggie Liu et al, Efficacy, safety and dose selection of AZD3759 in patients with untreated EGFR-mutated non-small-cell lung cancer and central nervous system metastases in China (CTONG1702-Arm 8): a multi-center, single-arm, phase 2 trial. eClinicalMedicine. DOI: 10.1016/j.eclinm.2023.102238[6]CELL Sub-Journal Publication: Zoritini Offers Survival Benefits as First-Line Treatment for Non-Small Cell Lung Cancer with Brain Metastases. Retrieved Oct 14, 2024, from https://mp.weixin.qq.com/s/IOWLobA2l_tUl55-cjhpuw
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