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    DRUG:

    Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)

    i
    Other names: Ami-LC, Ami-HC, CNTO-4424, JNJ-611, JNJ-61186372, JNJ61186372, CNTO4424, JNJ611, CNTO 4424, JNJ 611, JNJ 61186372
    Associations

    News

    Trials
    Company:
    Halozyme, J&J
    Drug class:
    EGFR inhibitor, c-MET inhibitor
    Related drugs:
    Associations

    News

    Trials
    9d
    PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
    P1, N=158, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2026 --> Apr 2027
    Trial completion date
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    EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
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    Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    9d
    Cost comparison of osimertinib plus platinum-pemetrexed versus amivantamab plus lazertinib for the first-line treatment of patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer. (PubMed, J Med Econ)
    These data limitations contributed to uncertainty surrounding model inputs. From a US payer perspective, osimertinib plus platinum-pemetrexed was associated with substantially lower overall costs compared with IV and SC amivantamab plus lazertinib for the 1L treatment of patients with EGFRm locally advanced or metastatic NSCLC.
    Clinical • Reimbursement • US reimbursement • Journal • HEOR
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    EGFR (Epidermal growth factor receptor)
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    EGFR mutation
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    Tagrisso (osimertinib) • pemetrexed • Lazcluze (lazertinib) • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    12d
    CAPT-HN: Combined Amivantamab, Carboplatin and Paclitaxel in Unresectable Locally Recurrent or Metastatic Head and Neck Cancer (clinicaltrials.gov)
    P2, N=50, Enrolling by invitation, SWOG Cancer Research Network | Not yet recruiting --> Enrolling by invitation
    Enrollment open
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    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
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    carboplatin • paclitaxel • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    20d
    Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus Chemotherapy in Patients With EGFR-mutant, Locally Advanced or Metastatic/Recurrent Non-Small Cell Lung Cancer (INSTAR Study) (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, Yonsei University
    New P2 trial
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    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
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    Tagrisso (osimertinib) • carboplatin • pemetrexed • Lazcluze (lazertinib) • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    25d
    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) | Initiation date: Oct 2026 --> Mar 2026
    Trial initiation date
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    mTOR (Mechanistic target of rapamycin kinase)
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    Erbitux (cetuximab) • Rybrevant (amivantamab-vmjw) • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    2ms
    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
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    Tagrisso (osimertinib) • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    2ms
    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
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    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
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    Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    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 | 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)
    6ms
    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)
    6ms
    The Phase 2b COPERNICUS Study of Subcutaneous Amivantamab with Lazertinib as First-Line Treatment, or with Chemotherapy as Second-Line Treatment, for EGFR-Mutated Non-Small Cell Lung Cancer: a Vodcast. (PubMed, Oncol Ther)
    COPERNICUS uses a pragmatic study design to evaluate the efficacy and safety of subcutaneous amivantamab regimens combined with advancements in supportive care to prevent and proactively manage AEs in a diverse participant population. Supplementary file1 (MP4 117333 KB).
    P2b data • Journal
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    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    carboplatin • pemetrexed • Lazcluze (lazertinib) • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    7ms
    PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
    P1, N=192, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Apr 2027 --> Dec 2026
    Trial completion date
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Lazcluze (lazertinib) • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    8ms
    COCOON: Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib (clinicaltrials.gov)
    P2, N=300, Recruiting, Janssen Research & Development, LLC | Trial completion date: Mar 2026 --> Jan 2032 | Trial primary completion date: Nov 2025 --> May 2027
    Trial completion date • Trial primary completion date • Adverse events
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    EGFR (Epidermal growth factor receptor)
    |
    EGFR L858R • EGFR exon 19 deletion
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    Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) • minocycline