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    DRUG:

    Zegfrovy (sunvozertinib)

    i
    Other names: DZD9008, DZD-9008, DZD 9008
    Company:
    Dizal Pharma
    Drug class:
    EGFR inhibitor, HER2 inhibitor, BTK inhibitor
    Related drugs:
    15d
    Efficacy and safety of later-line targeted therapies in advanced non-small cell lung cancer with EGFR exon 20 insertion mutations: a systematic review. (PubMed, Front Pharmacol)
    Recent developments in targeted therapies, including agents such as amivantamab, mobocertinib, and sunvozertinib, have shown promise in patients with pretreated ex20ins-positive NSCLC. No amendments were made to the registered protocol after commencement of the review. The full review protocol can be accessed on the PROSPERO database (Registration number: CRD420251056825).
    Review • Journal • IO biomarker
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Exkivity (mobocertinib) • Zegfrovy (sunvozertinib)
    19d
    A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21) (clinicaltrials.gov)
    P2, N=90, Recruiting, Dizal Pharmaceuticals | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Zegfrovy (sunvozertinib) • golidocitinib (DZD4205)
    26d
    Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8) (clinicaltrials.gov)
    P1/2, N=200, Recruiting, Dizal (Jiangsu) Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Tagrisso (osimertinib) • Zegfrovy (sunvozertinib)
    26d
    SUM-NSCLC-01: Sunvozertinib Treatment in Untreated Advanced NSCLC With EGFR Uncommon Mutations (clinicaltrials.gov)
    P2, N=34, Recruiting, Fudan University | N=14 --> 34
    Enrollment change
    |
    Zegfrovy (sunvozertinib)
    1m
    A Phase 3 Study of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Early-Stage Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery (clinicaltrials.gov)
    P3, N=360, Recruiting, Dizal (Jiangsu) Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Zegfrovy (sunvozertinib)
    1m
    Brain Metastatic Tumor Flare After Sunvozertinib Dose Reduction in a Patient with Surgical Resected EGFR ex20ins NSCLC. (PubMed, Onco Targets Ther)
    Our case highlighted the feasibility of sunvozertinib neoadjuvant therapy in EGFR ex20ins-positive NSCLC patient with locally advanced disease. Importantly, adjuvant therapy using an adequate dosage of sunvozertinib is pivotal to prevent disease flare and tumor recurrence.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR exon 20 insertion
    |
    Zegfrovy (sunvozertinib)
    1m
    Genetic modulation of ABCB1: Sunvozertinib reverses ABCB1-mediated multidrug resistance in cancer cells. (PubMed, Cancer Genet)
    Furthermore, treatment with sunvozertinib did not change protein expression or subcellular localization of ABCB1. Altogether, these data demonstrate that sunvozertinib, when combined with other conventional chemotherapeutic agents, can overcome MDR and improve therapeutic effect.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • ABCB1 (ATP Binding Cassette Subfamily B Member 1) • ABCG2 (ATP Binding Cassette Subfamily G Member 2) • ABCC1 (ATP Binding Cassette Subfamily C Member 1)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Zegfrovy (sunvozertinib)
    1m
    Neoadjuvant Sunvozertinib in Stage II-IIIB Non-small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutation. (clinicaltrials.gov)
    P2, N=24, Active, not recruiting, Shanghai Pulmonary Hospital, Shanghai, China
    New P2 trial
    |
    Zegfrovy (sunvozertinib)
    2ms
    Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) (clinicaltrials.gov)
    P1/2, N=315, Active, not recruiting, Dizal Pharmaceuticals | Trial completion date: Jul 2025 --> Dec 2025
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • HER-2 mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Zegfrovy (sunvozertinib)
    3ms
    Case Report: A Rare EGFR 20 Insertion Variant, P772_H773insGNP Mediates Resistance to Sunvozertinib but Is Sensitive to Furmonertinib. (PubMed, Cancer Manag Res)
    EGFR exon 20ins mutations are highly heterogeneous, and different subtypes exhibit varying sensitivities to targeted drugs. Exploring individualized treatment approaches is of great clinical importance.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Ivesa (firmonertinib) • Zegfrovy (sunvozertinib)
    4ms
    A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28) (clinicaltrials.gov)
    P3, N=324, Active, not recruiting, Dizal Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    carboplatin • pemetrexed • Zegfrovy (sunvozertinib)
    4ms
    Sunvozertinib Monotherapy in Advanced Lung Adenocarcinoma with EGFR Exon 20 Insertion and High PD-L1 Expression: A Case Report. (PubMed, Cancer Manag Res)
    This regimen yielded a prolonged progression-free survival, with manageable safety and tolerability profiles. These findings demonstrated that sunvozertinib could be a promising first-line treatment option for NSCLC patients with EGFR exon 20 insertion.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • EGFR mutation • PD-L1 overexpression • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Zegfrovy (sunvozertinib)