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    DRUG:

    Rybrevant (amivantamab-vmjw)

    i
    Other names: JNJ-61186372, EM1-mAb, JNJ 372, JNJ-372, JNJ-6372 , JNJ372, JNJ61186372, JNJ6372, JNJ 61186372, JNJ 6372
    Company:
    Genmab, J&J
    Drug class:
    EGFR inhibitor, c-MET inhibitor
    Related drugs:
    23d
    Amivantamab With Tyrosine Kinase Inhibitors (TKI) for Advanced NSCLC With ALK, ROS1, or RET Alterations (clinicaltrials.gov)
    P1/2, N=12, Active, not recruiting, University of Colorado, Denver | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    RET fusion • ALK fusion • ROS1 fusion
    |
    VENTANA ALK (D5F3) CDx Assay
    |
    Rybrevant (amivantamab-vmjw)
    1m
    CHRYSALIS-2: A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=701, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Jun 2026 --> Mar 2028
    Trial completion date
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR expression • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib)
    2ms
    OrigAMI-1: A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1/2, N=225, Recruiting, Janssen Research & Development, LLC | Trial completion date: Oct 2031 --> Oct 2030
    Trial completion date
    |
    5-fluorouracil • oxaliplatin • irinotecan • Rybrevant (amivantamab-vmjw) • leucovorin calcium
    2ms
    OrigAMI-5: A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer (clinicaltrials.gov)
    P3, N=500, Recruiting, Janssen Research & Development, LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • Rybrevant (amivantamab-vmjw)
    2ms
    KaRAnaSa: A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=60, Recruiting, Janssen Research & Development, LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Rybrevant (amivantamab-vmjw) • olomorasib (LY3537982)
    2ms
    A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=43, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jul 2026 --> Dec 2025 | Trial primary completion date: Jul 2026 --> Dec 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib)
    2ms
    Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System (clinicaltrials.gov)
    P2, N=86, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Dec 2025 --> Mar 2026
    Trial initiation date
    |
    Erbitux (cetuximab) • Rybrevant (amivantamab-vmjw)
    2ms
    The Landscape of Bispecific Antibodies in Solid Tumor Oncology: Trends, Challenges, and Opportunities. (PubMed, Cancer Med)
    Since the first BsAb approval in 2014, the field has rapidly expanded, with solid tumor oncology advancing dynamically. The major focus has been on combining BsAbs with immunotherapy strategies, followed by targeting known oncogenic pathways. The shift toward biotechnology-led innovation underscores the growing therapeutic and financial interest in this field. Optimizing the efficacy and safety of these molecules is key to paving the way for the next era of immune and precision oncology.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ALK (Anaplastic lymphoma kinase)
    |
    HER-2 positive
    |
    Rybrevant (amivantamab-vmjw) • Kaitanni (cadonilimab) • Yidafan (ivonescimab) • volrustomig (MEDI5752)
    2ms
    OrigAMI-5: A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer (clinicaltrials.gov)
    P3, N=500, Not yet recruiting, Janssen Research & Development, LLC
    New P3 trial
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • Rybrevant (amivantamab-vmjw)
    2ms
    METalmark: A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=57, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: May 2028 --> Mar 2027
    Trial completion date
    |
    Rybrevant (amivantamab-vmjw) • Tabrecta (capmatinib)
    2ms
    Amivantamab Plus Lazertinib in Atypical EGFR-Mutated Advanced Non-Small Cell Lung Cancer: Results From CHRYSALIS-2. (PubMed, J Clin Oncol)
    In participants with atypical EGFR-mutated advanced NSCLC, amivantamab-lazertinib demonstrated clinically meaningful antitumor activity with no new safety signals.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR exon 20 insertion • EGFR L861Q • EGFR G719X • EGFR S768I
    |
    Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib)
    2ms
    swalloWTail: A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=12, Active, not recruiting, Janssen Research & Development, LLC | Trial primary completion date: Oct 2025 --> Feb 2026
    Trial primary completion date
    |
    docetaxel • Rybrevant (amivantamab-vmjw)