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    DRUG:

    anetumab ravtansine (BAY 94-9343)

    i
    Other names: BAY 94-9343, BAY-94-9343, BAY-94-9343-SPDB-DM4, BAY94-9343​
    Company:
    AbbVie, Bayer, Novartis
    Drug class:
    Microtubule inhibitor, Mesothelin-targeted antibody-drug conjugate
    Related drugs:
    14d
    Development of recombinant Mesozumab-CPTin that dual-targets mesothelin and CP2c for anticancer therapy. (PubMed, Biomed Pharmacother)
    It efficiently promoted pancreatic cancer cell death without causing non-cancerous cytotoxicity from the early phase, showing anti-cancer properties than the commercial therapies including Cisplatin, Abraxane, Gemcitabine, and their combination treatment. In xenograft mice models for pancreatic cancer, Mesozumab-CPTin displayed lower average values in tumor volume and well-tolerated without significant side effects in a single high-dose acute toxicity assessment, compared to the anti-MSLN ADC Anetumab ravtansine. Mesozumab-CPTin is a genetically engineered peptide-based biomaterial to overcome limitations of traditional ADCs, which is a novel therapeutic candidate with stability and safety for pancreatic cancer.
    Journal
    |
    MSLN (Mesothelin)
    |
    cisplatin • gemcitabine • albumin-bound paclitaxel • anetumab ravtansine (BAY 94-9343)
    2ms
    Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Mesothelin-Positive Pleural Mesothelioma (clinicaltrials.gov)
    P1/2, N=49, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2025 --> Sep 2026
    Trial completion date
    |
    PD-L1 (Programmed death ligand 1) • MSLN (Mesothelin)
    |
    Keytruda (pembrolizumab) • anetumab ravtansine (BAY 94-9343)
    2ms
    NCI-2018-01503: Bevacizumab and Anetumab Ravtansine or Paclitaxel in Treating Patients With Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
    P2, N=96, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2025 --> Oct 2026
    Trial completion date • Trial primary completion date • Platinum resistant
    |
    MSLN (Mesothelin)
    |
    Avastin (bevacizumab) • paclitaxel • Aybintio (bevacizumab biosimilar) • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn) • anetumab ravtansine (BAY 94-9343)
    8ms
    Evaluating therapeutic plasma exchange and protease inhibitors as mechanisms to reduce soluble mesothelin. (PubMed, Sci Rep)
    We investigated the effects of sMSLN on anetumab, an antibody-based therapy against MSLN, anetumab ravtansine, an antibody drug conjugate, and mechanisms to decrease sMSLN...Overall, sMSLN could represent a predictive biomarker for MSLN directed therapies. TPE may be more reliable than PIs to reduce sMSLN and ultimately restore sensitivity to these therapies in patients with high sMSLN.
    Journal
    |
    MSLN (Mesothelin)
    |
    anetumab ravtansine (BAY 94-9343)
    9ms
    NCI10208: Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1, N=74, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2025 --> Jan 2026
    Trial completion date • Trial primary completion date • Tumor mutational burden
    |
    MSLN (Mesothelin)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • gemcitabine • anetumab ravtansine (BAY 94-9343) • ABP 206 (nivolumab biosimilar)
    11ms
    Randomized phase II study of bevacizumab with weekly anetumab ravtansine or weekly paclitaxel in platinum-resistant/refractory high grade ovarian cancer (NCI trial). (PubMed, Clin Cancer Res)
    Our study stopped at interim analysis highlighting the benefit of PB in prrHGOC as standard of care.
    P2 data • Journal
    |
    IL6 (Interleukin 6) • MSLN (Mesothelin)
    |
    Avastin (bevacizumab) • paclitaxel • anetumab ravtansine (BAY 94-9343)
    12ms
    NCI-2018-01503: Bevacizumab and Anetumab Ravtansine or Paclitaxel in Treating Patients With Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
    P2, N=96, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Oct 2025
    Trial completion date • Trial primary completion date
    |
    MSLN (Mesothelin)
    |
    MSLN positive
    |
    Avastin (bevacizumab) • paclitaxel • Aybintio (bevacizumab biosimilar) • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn) • anetumab ravtansine (BAY 94-9343)
    1year
    Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Mesothelin-Positive Pleural Mesothelioma (clinicaltrials.gov)
    P1/2, N=49, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2024 --> Sep 2025
    Trial completion date
    |
    PD-L1 (Programmed death ligand 1) • MSLN (Mesothelin)
    |
    MSLN expression
    |
    Keytruda (pembrolizumab) • anetumab ravtansine (BAY 94-9343)
    over1year
    Randomized trial of anetumab ravtansine and pembrolizumab compared to pembrolizumab for mesothelioma. (PubMed, Lung Cancer)
    The numeric difference in PFS between treatment groups was not statistically significant, likely related to a smaller than planned sample size. High levels of soluble mesothelin should potentially be considered to select against the use of mesothelin-targeting therapies in development that are neutralized by soluble mesothelin.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    MSLN (Mesothelin)
    |
    Keytruda (pembrolizumab) • anetumab ravtansine (BAY 94-9343)
    almost2years
    NCI10208: Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1, N=74, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
    Trial completion date • Trial primary completion date • Combination therapy • Tumor mutational burden • Metastases
    |
    MSLN (Mesothelin)
    |
    MSLN expression • MSLN positive
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • gemcitabine • anetumab ravtansine (BAY 94-9343) • ABP 206 (nivolumab biosimilar)
    2years
    NCI-2018-01503: Bevacizumab and Anetumab Ravtansine or Paclitaxel in Treating Patients With Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
    P2, N=96, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Oct 2024
    Trial completion date • Trial primary completion date
    |
    MSLN (Mesothelin)
    |
    MSLN positive
    |
    Avastin (bevacizumab) • paclitaxel • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn) • anetumab ravtansine (BAY 94-9343)
    2years
    NCI10208: Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=74, Active, not recruiting, National Cancer Institute (NCI) | Phase classification: P1 --> P1/2
    Phase classification • Combination therapy • Tumor mutational burden • IO biomarker • Metastases
    |
    CD8 (cluster of differentiation 8) • MSLN (Mesothelin)
    |
    MSLN expression • MSLN positive
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • gemcitabine • anetumab ravtansine (BAY 94-9343) • ABP 206 (nivolumab biosimilar)