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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:
    1d
    PALOMA-3: A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=418, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Jun 2026 --> Jun 2027
    Trial completion date
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
    |
    Tagrisso (osimertinib) • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    9d
    Amivantamab for Recurrent or Metastatic Adenoid Cystic Carcinoma: A Phase 2 Nonrandomized Clinical Trial. (PubMed, JAMA Otolaryngol Head Neck Surg)
    While the primary end point of best ORR was not met in this nonrandomized clinical trial, amivantamab was well tolerated, and most patients exhibited disease stabilization. ClinicalTrials.gov Identifier: NCT05074940.
    Clinical • P2 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    Rybrevant (amivantamab-vmjw)
    9d
    PAPILLON: A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions (clinicaltrials.gov)
    P3, N=308, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2026 --> Aug 2027
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw)
    17d
    Phase II trial of amivantamab plus monochemotherapy in platinum unfit NSCLC patients with EGFR exon20 insertion mutations (2025-520676-26-00)
    P1/2, N=35, Not yet recruiting, Fondazione Ricerca Traslazionale
    New P1/2 trial
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    pemetrexed • Rybrevant (amivantamab-vmjw)
    17d
    61186372NSC2012: A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (2025-520730-28-00)
    P1/2, N=118, Recruiting, Janssen Cilag International
    New P1/2 trial
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    17d
    61186372HNC3001: A Study of Amivantamab in Addition to Standard of Care Agents Compared with Standard ofnCare in Participants With Recurrent/Metastatic Head and Neck Cancer (2025-521917-24-00)
    P2/3, N=192, Recruiting, Janssen Cilag International
    New P2/3 trial
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • Rybrevant (amivantamab-vmjw)
    21d
    PALOMA-2: A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=520, Recruiting, Janssen Research & Development, LLC | Trial completion date: Aug 2027 --> Aug 2028
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    21d
    OrigAMI-2: A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer (clinicaltrials.gov)
    P3, N=1000, Recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2032 --> Jan 2032
    Trial completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • RAS (Rat Sarcoma Virus)
    |
    BRAF wild-type
    |
    Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • irinotecan • Rybrevant (amivantamab-vmjw) • leucovorin calcium • levoleucovorin calcium
    21d
    Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System (clinicaltrials.gov)
    P2, N=86, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Initiation date: Mar 2026 --> Oct 2026
    Enrollment open • Trial initiation date
    |
    mTOR (Mechanistic target of rapamycin kinase)
    |
    Erbitux (cetuximab) • Rybrevant (amivantamab-vmjw)
    2ms
    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)
    2ms
    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)
    3ms
    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