^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    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
    4d
    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=305, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting
    Enrollment closed • Adverse events
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR L858R • EGFR exon 19 deletion
    |
    Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    18d
    ORIC-114 in Combination With Subcutaneous Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC (clinicaltrials.gov)
    P1, N=76, Recruiting, ORIC Pharmaceuticals | Trial completion date: May 2027 --> Dec 2027 | Trial primary completion date: May 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    enozertinib (ORIC-114) • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    29d
    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
    |
    EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    30d
    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
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Tagrisso (osimertinib) • pemetrexed • Lazcluze (lazertinib) • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    1m
    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
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    carboplatin • paclitaxel • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    1m
    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
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Tagrisso (osimertinib) • carboplatin • pemetrexed • Lazcluze (lazertinib) • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    2ms
    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
    |
    mTOR (Mechanistic target of rapamycin kinase)
    |
    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
    |
    Tagrisso (osimertinib) • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    3ms
    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)
    3ms
    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)
    7ms
    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)
    7ms
    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
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    carboplatin • pemetrexed • Lazcluze (lazertinib) • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)