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    DRUG:

    tusamitamab ravtansine (SAR408701)

    i
    Other names: SAR408701, SAR 408701, SAR-408701, IBI-126
    Company:
    AbbVie, Innovent Biologics, Sanofi
    Drug class:
    Microtubule inhibitor, CEACAM5-targeted antibody-drug conjugate
    Related drugs:
    1d
    Biomarker analysis from a Phase 1/1b study of tusamitamab ravtansine in patients with advanced non-small cell lung cancer. (PubMed, Transl Oncol)
    In CEACAM5 HE, the ORR was greater with high versus low cCEA. Associations were observed between cCEA and cCEACAM5; IHC CEACAM5, cCEA, and cCEACAM5; IHC CEACAM5 and CEACAM5 mRNA, but not between IHC CEACAM5 and oncogenic drivers.
    P1 data • Journal
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    tusamitamab ravtansine (SAR408701)
    2ms
    CARMEN-BT01: Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=50, Terminated, Sanofi | Completed --> Terminated; Sponsor decision, the decision is not related to any safety concern.
    Trial termination
    |
    gemcitabine • tusamitamab ravtansine (SAR408701)
    2ms
    Evaluation of the Safety, Pharmacokinetics, and Antitumor Activity of Tusamitamab Ravtansine in Patients With Nonsquamous NSCLC With High or Moderate Expression of Carcinoembryonic Antigen-Related Cell Adhesion Molecule 5. (PubMed, JTO Clin Res Rep)
    Corneal AEs occurred in 38.0% (35/92), typically grade 1/2, reversible, and manageable by dose modifications. Tusamitamab ravtansine demonstrated a favorable safety profile, objective responses, and antitumor activity in patients with high CEACAM5-expressing NSq NSCLC.
    PK/PD data • Journal
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    tusamitamab ravtansine (SAR408701)
    4ms
    CARMEN-LC03: SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients (clinicaltrials.gov)
    P3, N=389, Active, not recruiting, Sanofi | Trial completion date: Jun 2025 --> Mar 2026
    Trial completion date
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    docetaxel • tusamitamab ravtansine (SAR408701)
    4ms
    Phase 1 study evaluating safety and pharmacokinetics of tusamitamab ravtansine monotherapy in Japanese patients with advanced malignant solid tumors. (PubMed, Int J Clin Oncol)
    Tusamitamab ravtansine demonstrated a tolerable safety profile at a dose of 80-170 mg/m2 in three different administration schedules in Japanese adults with metastatic solid tumors.
    P1 data • PK/PD data • Journal
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    tusamitamab ravtansine (SAR408701)
    7ms
    Diffuse interstitial lung disease induced by antibody-drug conjugates (PubMed, Rev Mal Respir)
    Among the many ADCs being developed, several can cause ILD of varying grades and intensity. Knowledge of their risks, diagnostic and therapeutic modalities is required in order to quickly detect and treat ADC-induced ILD.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • MET (MET proto-oncogene, receptor tyrosine kinase) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • patritumab deruxtecan (U3-1402) • Trodelvy (sacituzumab govitecan-hziy) • tusamitamab ravtansine (SAR408701) • Datroway (datopotamab deruxtecan-dlnk) • Emrelis (telisotuzumab vedotin-tllv)
    9ms
    CARMEN-BT01: Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=50, Completed, Sanofi | Active, not recruiting --> Completed
    Trial completion
    |
    gemcitabine • tusamitamab ravtansine (SAR408701)
    11ms
    CARMEN-LC05: Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLC (clinicaltrials.gov)
    P2, N=57, Terminated, Sanofi | Active, not recruiting --> Terminated; Sponsor decision, the decision is not related to any safety concern.
    Trial termination
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • tusamitamab ravtansine (SAR408701)
    11ms
    CARMEN-GC01: Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer (clinicaltrials.gov)
    P2, N=35, Terminated, Sanofi | Active, not recruiting --> Terminated; Sponsor decision, the decision is not related to any safety concern.
    Trial termination
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    Cyramza (ramucirumab) • tusamitamab ravtansine (SAR408701)
    11ms
    CARMEN-GC01: Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer (clinicaltrials.gov)
    P2, N=35, Terminated, Sanofi | Active, not recruiting --> Terminated; Sponsor decision, the decision is not related to any safety concern.
    Trial termination
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    Cyramza (ramucirumab) • tusamitamab ravtansine (SAR408701)
    12ms
    CARMEN-LC06: Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA (clinicaltrials.gov)
    P2, N=22, Terminated, Sanofi | Active, not recruiting --> Terminated; Sponsor decision, the decision is not related to any safety concern.
    Trial termination
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression
    |
    tusamitamab ravtansine (SAR408701)
    1year
    CARMEN-GC01: Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, Sanofi | Trial completion date: Jun 2024 --> Dec 2024
    Trial completion date • Combination therapy • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    Cyramza (ramucirumab) • tusamitamab ravtansine (SAR408701)