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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
    Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Pretreated Patients With NSQ NSCLC (CARMEN-LC04) (clinicaltrials.gov)
    P2, N=31, Terminated, Sanofi | Active, not recruiting --> Terminated; Sponsor decision, the decision is not related to any safety concern.
    Trial termination • Combination therapy • Checkpoint inhibition • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    Keytruda (pembrolizumab) • Cyramza (ramucirumab) • tusamitamab ravtansine (SAR408701)
    20d
    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: Aug 2026 --> Jun 2025
    Trial completion date
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    docetaxel • tusamitamab ravtansine (SAR408701)
    21d
    Structural insights into epitope-paratope interactions of a monoclonal antibody targeting CEACAM5-expressing tumors. (PubMed, Nat Commun)
    The antibody-drug conjugate tusamitamab ravtansine specifically recognizes the A3-B3 domains of human CEACAM5 (hCEACAM5)...The cryogenic electron microscopy structure of the hCEACAM5A3-B3- tusa Fab complex (3.11 Å overall resolution) reveals a discontinuous epitope involving residues in the A3-B3 domains and an N-linked mannose at residue Asn612. Conformational constraints on the epitope-paratope interface enable tusamitamab to target hCEACAM5A3-B3 and distinguish CEACAM5 from other CEACAMs.
    Journal
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression
    |
    tusamitamab ravtansine (SAR408701)
    1m
    CARMEN-LC06: Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA (clinicaltrials.gov)
    P2, N=22, Active, not recruiting, Sanofi | Trial completion date: Sep 2024 --> Dec 2024
    Trial completion date
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression
    |
    tusamitamab ravtansine (SAR408701)
    3ms
    The Study of Tusamitamab Ravtansine (IBI126) Combined With Sintilimab and Tusamitamab Ravtansine (IBI126) Combined With Sintilimab Plus Platinum-based Chemotherapy and Pemetrexed in Subjects With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) (clinicaltrials.gov)
    P2, N=4, Terminated, Innovent Biologics (Suzhou) Co. Ltd. | N=130 --> 4 | Trial completion date: Dec 2025 --> Dec 2023 | Not yet recruiting --> Terminated | Trial primary completion date: Apr 2024 --> Nov 2023; strategy terminates development, the decision is not due to any safety-related issues
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    cisplatin • carboplatin • Tyvyt (sintilimab) • pemetrexed • tusamitamab ravtansine (SAR408701)
    3ms
    CARMEN-BT01: Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=50, Active, not recruiting, Sanofi | Trial primary completion date: Aug 2024 --> Feb 2024
    Trial primary completion date • Metastases
    |
    gemcitabine • tusamitamab ravtansine (SAR408701)
    6ms
    CARMEN-LC06: Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA (clinicaltrials.gov)
    P2, N=22, Active, not recruiting, Sanofi | Trial completion date: May 2024 --> Sep 2024
    Trial completion date
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    tusamitamab ravtansine (SAR408701)
    7ms
    CARMEN-BT01: Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=50, Active, not recruiting, Sanofi | Trial primary completion date: Apr 2024 --> Aug 2024
    Trial primary completion date • Metastases
    |
    gemcitabine • tusamitamab ravtansine (SAR408701)
    7ms
    Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Pretreated Patients With NSQ NSCLC (CARMEN-LC04) (clinicaltrials.gov)
    P2, N=31, Active, not recruiting, Sanofi | Trial completion date: Mar 2024 --> Sep 2024
    Trial completion date • Combination therapy • Checkpoint inhibition • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    Keytruda (pembrolizumab) • Cyramza (ramucirumab) • tusamitamab ravtansine (SAR408701)
    7ms
    Assessment of carcinoembryonic antigen-related cell adhesion molecule 5 expression by immunohistochemistry in real-world clinical samples of non-small cell lung cancer. (ASCO 2024)
    We assessed the expression of CEACAM5 by IHC on clinical biopsy/resection samples of consecutively diagnosed NSCLC from September 2022 to June 2023 at our institution, using the anti-CEACAM5 clone 769 antibody assay protocol developed for tusamitamab ravtansine clinical trials... Our data showed that approximately 20% of routinely diagnosed clinical NSCLC samples had high CEACAM5 expression by IHC. The interrater reliability on the determination of high CEACAM5 expression was moderate among the three pathologists. We highlighted the challenging aspects in the evaluation of this biomarker.
    Real-world evidence • Clinical • PD(L)-1 Biomarker • IO biomarker • Real-world
    |
    EGFR (Epidermal growth factor receptor) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    PD-L1 IHC 22C3 pharmDx • Oncomine™ Comprehensive Assay v3M
    |
    tusamitamab ravtansine (SAR408701)
    7ms
    TusaRav-QT: Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=56, Terminated, Sanofi | Trial completion date: Aug 2024 --> Mar 2024 | Active, not recruiting --> Terminated; Tusamitamab ravtansine clinical development program is discontinued as CARMEN-LC03 trial did not meet dual primary endpoint of improving progression-free survival. The decision is not related to any safety concern.
    Trial completion date • Trial termination • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression
    |
    tusamitamab ravtansine (SAR408701)
    9ms
    INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701 (clinicaltrials.gov)
    P2, N=0, Withdrawn, Erasmus Medical Center | N=60 --> 0 | Trial completion date: May 2025 --> Feb 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Feb 2025 --> Feb 2024
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    tusamitamab ravtansine (SAR408701)
    9ms
    CEACAM5: Evaluation of SAR408701 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=254, Active, not recruiting, Sanofi | Trial completion date: Feb 2024 --> Aug 2024
    Trial completion date • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression • CEACAM5 positive
    |
    tusamitamab ravtansine (SAR408701)
    9ms
    CARMEN-LC06: Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA (clinicaltrials.gov)
    P2, N=22, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting | N=38 --> 22 | Trial completion date: Dec 2024 --> May 2024 | Trial primary completion date: Dec 2024 --> Jan 2024
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression
    |
    tusamitamab ravtansine (SAR408701)
    10ms
    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 (CARMEN-LC05) (clinicaltrials.gov)
    P2, N=57, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • tusamitamab ravtansine (SAR408701)
    10ms
    Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Pretreated Patients With NSQ NSCLC (CARMEN-LC04) (clinicaltrials.gov)
    P2, N=31, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    Keytruda (pembrolizumab) • Cyramza (ramucirumab) • tusamitamab ravtansine (SAR408701)
    10ms
    CARMEN-BT01: Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=50, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    gemcitabine • tusamitamab ravtansine (SAR408701)
    10ms
    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=411, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    docetaxel • tusamitamab ravtansine (SAR408701)
    12ms
    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: Oct 2023 --> Jun 2024
    Trial completion date
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    Cyramza (ramucirumab) • tusamitamab ravtansine (SAR408701)
    12ms
    CARMEN-BT01: Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=94, Recruiting, Sanofi | Trial completion date: Jan 2025 --> Aug 2025 | Trial primary completion date: Jul 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    gemcitabine • tusamitamab ravtansine (SAR408701)
    12ms
    CEACAM5: Evaluation of SAR408701 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=266, Active, not recruiting, Sanofi | Trial completion date: Aug 2023 --> Feb 2024
    Trial completion date • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression • CEACAM5 positive
    |
    tusamitamab ravtansine (SAR408701)
    1year
    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 (CARMEN-LC05) (clinicaltrials.gov)
    P2, N=215, Recruiting, Sanofi | Trial primary completion date: May 2024 --> Sep 2024
    Trial primary completion date • Combination therapy • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • tusamitamab ravtansine (SAR408701)
    1year
    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=450, Recruiting, Sanofi | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    docetaxel • tusamitamab ravtansine (SAR408701)
    1year
    A Randomized Phase II Study of Pembrolizumab and Ramucirumab with or without Tusamitamab-Ravtansine in CEACAM5 Expressing Previously Treated Stage IV or Recurrent NSCLC (Lung-MAP Sub-Study). (SWOG-Fall 2023)
    No abstract available
    Clinical • P2 data • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression
    |
    Keytruda (pembrolizumab) • Cyramza (ramucirumab) • tusamitamab ravtansine (SAR408701)
    1year
    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 (CARMEN-LC05) (clinicaltrials.gov)
    P2, N=215, Recruiting, Sanofi | N=120 --> 215
    Enrollment change • Combination therapy • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • tusamitamab ravtansine (SAR408701)
    1year
    The search for therapeutic targets in lung cancer: Preclinical and human studies of carcinoembryonic antigen-related cell adhesion molecule 5 expression and its associated molecular landscape. (PubMed, Lung Cancer)
    In NSQ-NSCLC tumors, CEACAM5 HE prevalence was 24.3% overall and was higher with KRAS altered and with PD-L1 negative/low tumors but similar regardless of EGFR mutation status. These findings support targeting CEACAM5 and the clinical development of tusamitamab ravtansine for patients with NSQ-NSCLC with CEACAM5 HE.
    Preclinical • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    KRAS mutation • EGFR mutation • PD-L1 negative • KRAS wild-type • CEACAM5 expression
    |
    tusamitamab ravtansine (SAR408701)
    1year
    TusaRav-QT: Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=56, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Aug 2024 | Trial primary completion date: Nov 2023 --> Aug 2023
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression
    |
    tusamitamab ravtansine (SAR408701)
    1year
    Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Pretreated Patients With NSQ NSCLC (CARMEN-LC04) (clinicaltrials.gov)
    P2, N=43, Recruiting, Sanofi | Trial primary completion date: Sep 2024 --> Dec 2024
    Trial primary completion date • Combination therapy • Checkpoint inhibition • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    Keytruda (pembrolizumab) • Cyramza (ramucirumab) • tusamitamab ravtansine (SAR408701)
    1year
    Tusamitamab Ravtansine in Patients with Advanced Solid Tumors: Phase I Study of Safety, Pharmacokinetics, and Antitumor Activity Using Alternative Dosing Regimens. (PubMed, Cancer Res Commun)
    (NCT02187848). The collective results of this phase I dose-escalation study will inform further studies of tusamitamab ravtansine in patients with solid tumors with CEACAM5 expression, including patients with non-small cell lung cancer.
    P1 data • PK/PD data • Clinical Trial,Phase I • Journal • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression
    |
    tusamitamab ravtansine (SAR408701)
    over1year
    Tusamitamab ravtansine plus ramucirumab as 2L therapy or beyond in patients with metastatic NSq NSCLC and high CEACAM5 expression (CARMEN-LC04) (ESMO 2023)
    Docetaxel ± ramucirumab (ram) every 3 weeks is standard second-line therapy for mNSQ NSCLC without targetable mutations after progression on immunotherapy ± chemotherapy. Conclusions Tusa rav + ram showed encouraging efficacy. The safety of this combination was consistent with the safety profile of each drug, with no unexpected safety signals.
    Clinical • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    EGFR mutation • BRAF mutation • CEACAM5 expression • CEACAM5 overexpression
    |
    docetaxel • Cyramza (ramucirumab) • tusamitamab ravtansine (SAR408701)
    over1year
    'Targeting' Improved Outcomes with Antibody-Drug Conjugates in Non-Small Cell Lung Cancer-An Updated Review. (PubMed, Curr Oncol)
    Recently, trastuzumab deruxtecan (TDXd) was the first ADC approved for previously treated metastatic HER2-mutant non-small cell lung cancer (NSCLC). Many promising ADCs are in the pipeline for clinical development in non-small cell lung cancer, including sacituzumab govitecan, patritumab deruxtecan, datopotamab deruxtecan and tusamitamab ravtansine...In this comprehensive review, we will be discussing the recent evidence including targets, efficacy and the safety of newer ADC candidates in NSCLC. We will also briefly discuss the specific toxicities, novel biomarkers, overcoming resistance mechanisms, challenges and the way forward, as these new ADCs and combinations find a way into the clinical practice.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • patritumab deruxtecan (U3-1402) • Trodelvy (sacituzumab govitecan-hziy) • tusamitamab ravtansine (SAR408701) • datopotamab deruxtecan (DS-1062a)
    over1year
    The Study of Tusamitamab Ravtansine (IBI126) Combined With Sintilimab and Tusamitamab Ravtansine (IBI126) Combined With Sintilimab Plus Platinum-based Chemotherapy and Pemetrexed in Subjects With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) (clinicaltrials.gov)
    P2, N=130, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.
    New P2 trial
    |
    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    BRAF mutation
    |
    cisplatin • carboplatin • Tyvyt (sintilimab) • pemetrexed • tusamitamab ravtansine (SAR408701)
    over1year
    Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Pretreated Patients With NSQ NSCLC (CARMEN-LC04) (clinicaltrials.gov)
    P2, N=43, Recruiting, Sanofi | Trial primary completion date: Apr 2023 --> Aug 2024
    Trial primary completion date • Combination therapy • Checkpoint inhibition • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    Keytruda (pembrolizumab) • Cyramza (ramucirumab) • tusamitamab ravtansine (SAR408701)
    over1year
    CARMEN-LC06: Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA (clinicaltrials.gov)
    P2, N=38, Recruiting, Sanofi | Trial completion date: May 2024 --> Sep 2024 | Trial primary completion date: Feb 2024 --> Sep 2024
    Trial completion date • Trial primary completion date
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression
    |
    tusamitamab ravtansine (SAR408701)
    over1year
    Industry Expert Theater: Sanofi Oncology Pipeline and CEACAM5: A Potential Biomarker in Advanced Non-Small Cell Lung Cancer for Targeted Therapies (ASCO 2023)
    Sponsored by Sanofi. Join us for an overview of Sanofi’s oncology pipeline with a focus on tusamitamab ravtansine (SAR408701), an ADC selectively targeting CEACAM5-expression tumors with promising antitumor activity and a favorable safety profile in heavily pretreated patients with CEACAM5 positive advanced NSQ NSCLC.
    Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression • CEACAM5 positive
    |
    tusamitamab ravtansine (SAR408701)
    over1year
    Long-term efficacy of tusamitamab ravtansine in CEACAM5-positive nonsquamous non-small cell lung cancer (NSQ NSCLC) (JSMO 2023)
    No abstract available
    Clinical
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 positive
    |
    tusamitamab ravtansine (SAR408701)
    over1year
    CARMEN-GC01: Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer (clinicaltrials.gov)
    P2, N=34, Active, not recruiting, Sanofi | Trial completion date: Aug 2023 --> Nov 2023
    Trial completion date • Combination therapy • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    Cyramza (ramucirumab) • tusamitamab ravtansine (SAR408701)
    over1year
    CEACAM5: Evaluation of SAR408701 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=263, Active, not recruiting, Sanofi | Phase classification: P1/2 --> P1
    Phase classification • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression • CEACAM5 positive
    |
    tusamitamab ravtansine (SAR408701)
    over1year
    CEACAM5: Evaluation of SAR408701 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=263, Active, not recruiting, Sanofi | Trial completion date: Mar 2023 --> Aug 2023
    Trial completion date • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression • CEACAM5 positive
    |
    tusamitamab ravtansine (SAR408701)
    almost2years
    CARMEN-GC01: Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer (clinicaltrials.gov)
    P2, N=34, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting | Trial completion date: Nov 2023 --> Aug 2023
    Enrollment closed • Trial completion date
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    Cyramza (ramucirumab) • tusamitamab ravtansine (SAR408701)
    almost2years
    Safety and efficacy of tusamitamab ravtansine in combination with pembrolizumab ± chemotherapy in patients with CEACAM5-positive nonsquamous NSCLC (CARMEN-LC05 phase 2 study) (ELCC 2023)
    Methods CARMEN-LC05 assessed safety and antitumor activity of tusa rav in combination with SoC regimens: with pembro [T2]; with pembro + platinum-based chemotherapy (pCT) [T3]; and with pembro + pCT + pemetrexed [T4] in patients with advanced/metastatic NSQ NSCLC with CEACAM5 intensity of ≥2+ in ≥1% of tumor cells by immunohistochemistry. Objective response rate (ORR) and disease control rate (DCR) for all patients were 40% and 88%, respectively. Table: 13MO Conclusions Tusa rav combined with SoC showed encouraging antitumor activity across all treatment arms with a favorable safety profile, including in the T4 arm, and no new safety concerns, supporting ongoing evaluation of tusa rav.
    Clinical • P2 data • Combination therapy • PD(L)-1 Biomarker
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 positive
    |
    Keytruda (pembrolizumab) • pemetrexed • tusamitamab ravtansine (SAR408701)