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    DRUG:

    Aidixi (disitamab vedotin)

    i
    Other names: RC48, RC48-ADC, RC 48-ADC, RC 48
    Company:
    Pfizer, Rongchang Pharma
    Drug class:
    Microtubule inhibitor, HER2-targeted antibody-drug conjugate
    Related drugs:
    3d
    RC48 Combined With Adebrelimab and Apatinib and S-1 of the Neoadjuvant Therapy of Locally Advanced Gastric Cancer (clinicaltrials.gov)
    P2, N=32, Not yet recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P2 trial • Metastases
    |
    AiTan (rivoceranib) • Aidixi (disitamab vedotin) • Teysuno (gimeracil/oteracil/tegafur) • adebrelimab (SHR-1316)
    3d
    Disitamab Vedotin Plus Cadonilimab in Patients With HER2 Mutant Advanced or Metastatic Bile Duct Adenocarcinoma (clinicaltrials.gov)
    P2, N=28, Recruiting, Zhejiang Cancer Hospital
    New P2 trial • Metastases
    |
    Aidixi (disitamab vedotin) • Kaitanni (cadonilimab)
    6d
    To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2 (clinicaltrials.gov)
    P1/2, N=24, Not yet recruiting, RemeGen Co., Ltd.
    New P1/2 trial
    |
    Aidixi (disitamab vedotin)
    12d
    HCCSC-C03: Disitamab Vedotin Combined With Fruquintinib for mCRC With HER2 Expression (clinicaltrials.gov)
    P4, N=51, Active, not recruiting, Zhongnan Hospital | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification • HER-2 mutation • HER-2 expression
    |
    Aidixi (disitamab vedotin) • Fruzaqla (fruquintinib)
    20d
    DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC (clinicaltrials.gov)
    P2, N=20, Recruiting, Fudan University
    New P2 trial
    |
    Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin)
    24d
    Optimal Sequential Strategies for Antibody-Drug Conjugate in Metastatic Breast Cancer: Evaluating Efficacy and Cross-Resistance. (PubMed, Oncologist)
    The alternation of payload achieves different responses in different settings. T-Dxd followed by RC48 may be a potentially beneficial strategy in HER2-positive disease. Further research is needed to elucidate the mechanism of cross-resistance.
    Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • RB1 (RB Transcriptional Corepressor 1)
    |
    HER-2 positive • EGFR positive
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Aidixi (disitamab vedotin) • Trodelvy (sacituzumab govitecan-hziy)
    26d
    DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy (clinicaltrials.gov)
    P2/3, N=90, Recruiting, RemeGen Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    paclitaxel • Aidixi (disitamab vedotin) • Kaitanni (cadonilimab)
    26d
    Implementation of antibody-drug conjugates in HER2-positive solid cancers: Recent advances and future directions. (PubMed, Biomed Pharmacother)
    This review focuses on three approved anti-HER2 ADCs (T-DM1, DS-8201a, and RC48) and reviews ongoing clinical trials and failed trials based on anti-HER2 ADCs. Finally, we address the notable challenges linked to ADC development and underscore potential future avenues for tackling these hurdles.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • ERBB4 (erb-b2 receptor tyrosine kinase 4)
    |
    HER-2 positive • HER-2 overexpression
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Aidixi (disitamab vedotin)
    2ms
    Expression of HER2 in high-grade urothelial carcinoma based on Chinese expert consensus and the clinical effects of disitamab vedotin-tislelizumab combination therapy in the treatment of advanced patients. (PubMed, Front Pharmacol)
    HER2+ expression is positively correlated with higher clinical stage of UC. HER2 targeted ADC drug disitamab vedotin combining with PD-1 inhibitor tislelizumab has shown efficacy, safety and controllable adverse reactions in the treatment of advanced UC.
    Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    Tevimbra (tislelizumab) • Aidixi (disitamab vedotin)
    2ms
    Efficacy and safety of disitamab vedotin after trastuzumab for HER2 positive breast cancer: a real-world data of retrospective study. (PubMed, Am J Cancer Res)
    Disitamab vedotin (RC48) is a novel cleavable antibody-drug conjugate (ADC) that has shown promising preclinical activity in HER2-positive breast cancer. RC48 exhibited potent activity for patients regardless of trastuzumab resistance or refractory. The sequence of pyrotinib and RC48 did not influence their total efficacy, indicating no cross-resistance.
    Retrospective data • Journal • Real-world evidence • Real-world
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Irene (pyrotinib) • Aidixi (disitamab vedotin)
    2ms
    Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, RemeGen Co., Ltd. | Initiation date: Dec 2023 --> Dec 2024
    Trial initiation date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 expression • HER-2 underexpression • PGR expression
    |
    Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin)
    2ms
    A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases (clinicaltrials.gov)
    P2/3, N=301, Active, not recruiting, RemeGen Co., Ltd. | Trial primary completion date: Dec 2023 --> Jul 2024
    Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    lapatinib • capecitabine • Aidixi (disitamab vedotin)
    2ms
    A Study of RC48-ADC in Advanced Melanoma Subjects With HER2 Variant (Mutation, Amplification, Overexpression) (clinicaltrials.gov)
    P2, N=50, Recruiting, RemeGen Co., Ltd. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Aidixi (disitamab vedotin)
    2ms
    Neoadjuvant Study of DV Plus Toripalimab in Combination or Sequence With Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer (clinicaltrials.gov)
    P2, N=160, Recruiting, RemeGen Co., Ltd. | Not yet recruiting --> Recruiting | Initiation date: Jan 2024 --> Jul 2023
    Enrollment open • Trial initiation date
    |
    carboplatin • Loqtorzi (toripalimab-tpzi) • cyclophosphamide • epirubicin • Aidixi (disitamab vedotin)
    2ms
    DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer (clinicaltrials.gov)
    P2, N=80, Recruiting, RemeGen Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    Perjeta (pertuzumab) • Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin)
    2ms
    Comparison of trastuzumab emtansine, trastuzumab deruxtecan, and disitamab vedotin in a multiresistant HER2-positive breast cancer lung metastasis model. (PubMed, Clin Exp Metastasis)
    L-JIMT-1 cells were resistant to all five tyrosine kinase inhibitors tested in vitro (afatinib, erlotinib, lapatinib, sapitinib, and tucatinib). In a mouse model, all three ADCs inhibited the growth of L-JIMT-1 lung metastases compared to a vehicle, but DV and T-DXd more strongly than T-DM1, and DV treatment led to the smallest tumor burden. The L-JIMT breast cancer lung metastasis model developed may be useful in the evaluation of anti-cancer agents for multiresistant HER2-positive advanced breast cancer.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • EGFR expression
    |
    erlotinib • Gilotrif (afatinib) • lapatinib • Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Tukysa (tucatinib) • Aidixi (disitamab vedotin) • sapitinib (AZD8931)
    2ms
    A Study of the Treatment of Disitamab Vedotin in Patients With Locally Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2, N=63, Not yet recruiting, Sun Yat-sen University
    New P2 trial • Metastases
    |
    gemcitabine • Aidixi (disitamab vedotin)
    3ms
    mTOR inhibitor introduce disitamab vedotin (RC48-ADC) rechallenge microtubule-chemotherapy resistance in HER2-low MBC patients with PI3K mutation. (PubMed, Front Oncol)
    Here we reported two clinical cases of HER2-low MBC patients whose disease progressed after prior treatment with MTAs such as docetaxel and vincristine. The patients were treated with everolimus before being rechallenged with RC48, which may lead to a better response. This study further summarizes and analyzes the potential mechanism of the PI3K-AKT signaling pathway in MTA resistance and reveals that the PIK3CA H1047R mutation may be a potential molecular marker for the efficacy prediction of mTOR inhibitors, providing new insights and potential therapeutic strategies for the application of MTAs to MBC patients.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PI3K (Phosphoinositide 3-kinases)
    |
    PIK3CA mutation • PIK3CA H1047R
    |
    docetaxel • everolimus • Aidixi (disitamab vedotin) • vincristine
    3ms
    A Study of Disitamab Vedotin Alone or With Other Anticancer Drugs in Solid Tumors (clinicaltrials.gov)
    P1/2, N=198, Recruiting, Seagen Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Tukysa (tucatinib) • Aidixi (disitamab vedotin)
    3ms
    DV With HER2 Expression, Gene Amplification or Mutation Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=60, Not yet recruiting, RemeGen Co., Ltd.
    New P1 trial • Metastases
    |
    Aidixi (disitamab vedotin)
    3ms
    Neoadjuvant Study of DV Plus Toripalimab in Combination or Sequence With Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer (clinicaltrials.gov)
    P2, N=160, Not yet recruiting, RemeGen Co., Ltd.
    New P2 trial
    |
    carboplatin • Loqtorzi (toripalimab-tpzi) • cyclophosphamide • epirubicin • Aidixi (disitamab vedotin)
    3ms
    RC48-ADC combined with tislelizumab as neoadjuvant treatment in patients with HER2-positive locally advanced muscle-invasive urothelial bladder cancer: a multi-center phase Ib/II study (HOPE-03). (PubMed, Front Oncol)
    For HER2-positive MIBC, the efficacy of cisplatin-based NAC is unsatisfactory, and adverse reactions are inevitable or even intolerable. The HOPE-03 trial provides a description of the safety profile of RC-48 and tislelizumab combination in the neoadjuvant treatment of HER2-positive locally advanced urothelial MIBC, and the efficacy is explored as well in this population. https://www.chictr.org.cn/showproj.html?proj=137111, identifier ChiCTR2200060153.
    P1/2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    cisplatin • Tevimbra (tislelizumab) • Aidixi (disitamab vedotin)
    3ms
    A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2 (clinicaltrials.gov)
    P3, N=366, Recruiting, RemeGen Co., Ltd. | Trial primary completion date: Dec 2023 --> Jun 2024
    Trial primary completion date • Metastases
    |
    HR positive • HER-2 expression • HER-2 underexpression
    |
    paclitaxel • docetaxel • capecitabine • Aidixi (disitamab vedotin) • vinorelbine tartrate
    3ms
    DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy (clinicaltrials.gov)
    P2/3, N=90, Not yet recruiting, RemeGen Co., Ltd.
    New P2/3 trial • Metastases
    |
    paclitaxel • Aidixi (disitamab vedotin) • Kaitanni (cadonilimab)
    3ms
    Disitamab vedotin (RC48) plus toripalimab for HER2-expressing advanced gastric or gastroesophageal junction and other solid tumours: a multicentre, open label, dose escalation and expansion phase 1 trial. (PubMed, EClinicalMedicine)
    The findings of our phase 1 clinical trial support further investigation of HER2-targeted ADC plus immunotherapy in HER2-expressing G/GEJ cancer and pancancer treatment in the future. Beijing Municipal Medical Research Institutes, Beijing Medical Research Institute (Z200015).
    P1 data • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin)
    3ms
    A Clinical Study of the Efficacy and Safety of Disitamab Vedotin in Combination With Radiotherapy for the Adjuvant Treatment of HER2 Overexpressing UTUC Patients With High Risk Factors for Recurrence After Radical Surgery (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Peking University First Hospital
    New P2 trial • Combination therapy • Surgery
    |
    Aidixi (disitamab vedotin)
    3ms
    A Study of RC48-ADC Combination With Zimberelimab Injection Therapies at Least First-line Platinum-containing Standard Therapy Failed With Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov)
    P2, N=116, Recruiting, RemeGen Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Aidixi (disitamab vedotin) • Yutuo (zimberelimab)
    4ms
    RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2 (clinicaltrials.gov)
    P1/2, N=42, Recruiting, Chinese PLA General Hospital | Trial completion date: Sep 2024 --> Sep 2026 | Trial primary completion date: Sep 2023 --> Sep 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Aidixi (disitamab vedotin) • Teysuno (gimeracil/oteracil/tegafur)
    4ms
    Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Fudan University
    New P2 trial
    |
    Aidixi (disitamab vedotin)
    4ms
    A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation (clinicaltrials.gov)
    P1/2, N=26, Not yet recruiting, RemeGen Co., Ltd.
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation • HER-2 exon 20 insertion • HER-2 exon 20 mutation • HER-2 exon 23 mutation
    |
    Irene (pyrotinib) • Aidixi (disitamab vedotin)
    4ms
    RC48-ADC in Breast Cancer (clinicaltrials.gov)
    P=N/A, N=45, Recruiting, RenJi Hospital
    Trial completion date • Trial primary completion date • Real-world evidence • Real-world
    |
    Aidixi (disitamab vedotin)
    4ms
    Advances in HER2-Targeted Treatment for Advanced/Metastatic Urothelial Carcinoma. (PubMed, Bladder (San Franc))
    Trials involving trastuzumab, pertuzumab, lapatinib, afatinib, and neratinib have failed to prove their beneficial effect in patients with HER2-positive mUC, and a clinical trial on T-DM1 (trastuzumab emtansine) was terminated prematurely because of the adverse reactions. However, a phase II trial showed that RC48-ADC was effective. In this review, we provided an in-depth overview of the advances in the research regarding HER2-targeted therapy and the role of HER2 in mUC. Furthermore, we also discussed the prospects of potential strategies aimed at overcoming anti-HER2 resistance, and summarize the novel anti-HER2 approaches for the management of mUC used in recent clinical trials.
    Review • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification
    |
    Gilotrif (afatinib) • lapatinib • Nerlynx (neratinib) • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • Aidixi (disitamab vedotin)
    4ms
    RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations (clinicaltrials.gov)
    P2, N=108, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New P2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Tagrisso (osimertinib) • Irene (pyrotinib) • Ameile (aumolertinib) • Aidixi (disitamab vedotin) • Ivesa (furmonertinib)
    4ms
    HCCSC-C03: Disitamab Vedotin Combined With Fruquintinib for mCRC With HER2 Expression (clinicaltrials.gov)
    P4, N=51, Active, not recruiting, Zhongnan Hospital | N=12 --> 51
    Enrollment change • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification • HER-2 mutation • HER-2 expression
    |
    Aidixi (disitamab vedotin) • Fruzaqla (fruquintinib)
    4ms
    Efficacy and safety analysis of a HER2-targeting antibody-drug conjugate combined with immune checkpoint inhibitors in solid tumors: a real-world study. (PubMed, Aging (Albany NY))
    Our study showed that Disitamab-Vedotin-based treatment, alone or in combination with ICIs, exerted considerable prognosis and good tolerance in patients with locally advanced or metastatic solid tumors, regardless of the HER2 expression levels. Whether combination therapy with ICIs provides greater therapeutic benefits compared to monotherapy needs to be further explored through randomized controlled trials.
    Journal • Checkpoint inhibition • Real-world evidence • IO biomarker • Real-world
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Aidixi (disitamab vedotin)
    4ms
    A Study of RC48-ADC Combined With Cadonilimab（AK104）in the Treatment of HER2-expression Locally Advanced or Metastatic Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=36, Recruiting, Shanxi Province Cancer Hospital
    New P2 trial • Metastases
    |
    Aidixi (disitamab vedotin) • Kaitanni (cadonilimab)
    4ms
    A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2 (clinicaltrials.gov)
    P3, N=366, Recruiting, RemeGen Co., Ltd. | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    HR positive • HER-2 expression • HER-2 underexpression
    |
    paclitaxel • docetaxel • capecitabine • Aidixi (disitamab vedotin) • vinorelbine tartrate
    4ms
    A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression (clinicaltrials.gov)
    P3, N=351, Recruiting, RemeGen Co., Ltd. | Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    paclitaxel • AiTan (rivoceranib) • irinotecan • Aidixi (disitamab vedotin)
    4ms
    Immune checkpoint inhibitors enhanced the antitumor efficacy of disitamab vedotin for patients with HER2-positive or HER2-low advanced or metastatic gastric cancer: a multicenter real-world study. (PubMed, BMC Cancer)
    Compared with RC48 monotherapy, ICIs plus RC48 demonstrated superior third-line and beyond therapeutic efficacy for HER2-positive or HER2-low advanced and metastatic gastric cancer patients with manageable safety.
    Journal • Checkpoint inhibition • Real-world evidence • Real-world • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Aidixi (disitamab vedotin)
    4ms
    A Study of RC48-ADC in Subjects With HER2 Overexpressed Metastatic Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=57, Active, not recruiting, RemeGen Co., Ltd. | Trial completion date: Dec 2023 --> Jun 2024
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression
    |
    Aidixi (disitamab vedotin)
    4ms
    DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, RemeGen Co., Ltd.
    New P2 trial
    |
    Perjeta (pertuzumab) • Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin)
    4ms
    C003 CANCER: A Study of RC48-ADC in Subjects With Advanced Breast Cancer (clinicaltrials.gov)
    P1/2, N=112, Completed, RemeGen Co., Ltd. | Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Apr 2023
    Trial completion • Trial completion date • Metastases
    |
    Aidixi (disitamab vedotin)