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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:
    3d
    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)
    6d
    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)
    7d
    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)
    13d
    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)
    18d
    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)
    23d
    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)
    1m
    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: Jan 2026 --> Sep 2026
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw)
    1m
    KaRAnaSa: A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=60, Not yet recruiting, Janssen Research & Development, LLC
    New P1/2 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Rybrevant (amivantamab-vmjw) • olomorasib (LY3537982)
    1m
    OrigAMI-4: A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer (clinicaltrials.gov)
    P1/2, N=287, Recruiting, Janssen Research & Development, LLC | Trial completion date: Apr 2028 --> Dec 2032
    Trial completion date
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • Rybrevant (amivantamab-vmjw)
    2ms
    Amivantamab-Chemotherapy in Non-Small Cell Lung Cancer with EGFR Exon 20 Insertions: Impact of Treatment Crossover and Other Endpoints from the Phase III PAPILLON Study. (PubMed, Target Oncol)
    In PAPILLON, TTD and TTST were substantially longer for amivantamab-chemotherapy versus chemotherapy at primary analysis (cut-off on 3 May 2023). Crossover-adjusted analyses of the planned interim overall survival demonstrated a greater benefit for amivantamab-chemotherapy versus chemotherapy, further supporting amivantamab-chemotherapy as the first-line standard of care in EGFR exon 20 insertion-mutated non-small cell lung cancer.
    P3 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw)
    2ms
    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 | N=390 --> 520
    Enrollment change
    |
    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)
    2ms
    OrigAMI-4: A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer (clinicaltrials.gov)
    P1/2, N=287, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Jul 2026 --> Dec 2027
    Trial primary completion date
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • Rybrevant (amivantamab-vmjw)