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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:
    1d
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    3ms
    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, Not yet recruiting, Dizal (Jiangsu) Pharmaceutical Co., Ltd.
    New P3 trial
    |
    Zegfrovy (sunvozertinib)
    3ms
    Phase II Dose-Randomized Study of Sunvozertinib in Platinum-Pretreated Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 20 Insertion Mutations (WU-KONG1B). (PubMed, J Clin Oncol)
    Sunvozertinib is efficacious at both 200 and 300 mg once daily in treating platinum-pretreated patients with advanced EGFR exon20ins NSCLC. The treatment-related adverse events of sunvozertinib were consistent with an EGFR tyrosine kinase inhibitor, with a more favorable safety profile at 200 mg than 300 mg once daily.
    P2 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Rybrevant (amivantamab-vmjw) • Zegfrovy (sunvozertinib)
    4ms
    SUM-NSCLC-01: Sunvozertinib Treatment in Untreated Advanced NSCLC With EGFR Uncommon Mutations (clinicaltrials.gov)
    P2, N=14, Recruiting, Fudan University
    New P2 trial
    |
    Zegfrovy (sunvozertinib)
    4ms
    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, Not yet recruiting, Dizal (Jiangsu) Pharmaceutical Co., Ltd.
    New P1/2 trial
    |
    Tagrisso (osimertinib) • Zegfrovy (sunvozertinib)
    5ms
    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: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2025 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    Zegfrovy (sunvozertinib) • golidocitinib (DZD4205)
    5ms
    Efficacy and Safety of Sunvozertinib Monotherapy as First-line Treatment in NSCLC Patients with EGFR Exon 20 Insertion Mutations: A Phase 2, Single-center Trial. (PubMed, Cancer Lett)
    Negativity of plasma EGFR exon20ins ctDNA correlated with better tumor response. In conclusion, sunvozertinib monotherapy demonstrated significant and durable antitumor efficacy and was well-tolerated in treatment-naïve patients with EGFR exon20ins NSCLC, suggesting its potential as a favourable first-line treatment option.
    P2 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Zegfrovy (sunvozertinib)
    6ms
    DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29) (clinicaltrials.gov)
    P2, N=60, Recruiting, Dizal Pharmaceuticals | Trial primary completion date: May 2025 --> Dec 2025
    Trial primary completion date
    |
    Avastin (bevacizumab) • Zegfrovy (sunvozertinib)
    7ms
    Genetic biomarker study of sunvozertinib for clinical prognosis and prediction in NSCLC with EGFR exon 20 insertion mutation. (PubMed, Cell Rep Med)
    Acquired EGFR C797S is identified as a potential on-target resistance mutation to sunvozertinib. Finally, efforts are undertaken to investigate therapeutic approaches that aim to overcome the putative acquired resistance to sunvozertinib.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation • EGFR positive
    |
    Zegfrovy (sunvozertinib)