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    DRUG:

    Rybrevant (amivantamab-vmjw)

    i
    Other names: JNJ 6372, JNJ-61186372, EM1-mAb, JNJ 372, JNJ-372, JNJ-6372 , JNJ372, JNJ61186372, JNJ6372, JNJ 61186372
    Company:
    Genmab, J&J
    Drug class:
    EGFR inhibitor, c-MET inhibitor
    Related drugs:
    4d
    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)
    9d
    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)
    21d
    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)
    22d
    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)
    24d
    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)
    1m
    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) • amivantamab SC (Ami-LC)
    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)
    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: Apr 2026 --> May 2028
    Trial completion date
    |
    Rybrevant (amivantamab-vmjw) • Tabrecta (capmatinib)
    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: May 2029 --> Oct 2031
    Trial completion date
    |
    5-fluorouracil • oxaliplatin • irinotecan • Rybrevant (amivantamab-vmjw) • leucovorin calcium
    2ms
    PolyDamas: A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=71, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2026 --> Mar 2027
    Trial completion date
    |
    EGFR L858R • EGFR exon 19 deletion
    |
    Rybrevant (amivantamab-vmjw) • cetrelimab (JNJ-63723283)
    3ms
    SKIPPirr: Premedication to Reduce Amivantamab Associated Infusion Related Reactions (clinicaltrials.gov)
    P2, N=73, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Oct 2025 --> Jul 2026
    Trial completion date
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Tagrisso (osimertinib) • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib)