MedPath

Amivantamab

Generic Name
Amivantamab
Brand Names
Rybrevant
Drug Type
Biotech
Chemical Formula
-
CAS Number
2171511-58-1
Unique Ingredient Identifier
0JSR7Z0NB6
Background

Amivantamab, also known as JNJ-61186372, is an anti-EGFR-MET bispecific antibody, derived from Chinese hamster ovary cells, approved for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. Patients with NSCLC often develop resistance to drugs that target EGFR and MET individually, so amivantamab was developed to attack both targets, reducing the chance of resistance developing. Amivantamab was found to be more effective than the EGFR inhibitor erlotinib or the MET inhibitor crizotinib in vivo. Patients with NSCLC with exon 20 insertion mutations in EGFR do not respond to tyrosine kinase inhibitors, and were generally treated with platinum-based therapy.

Amivantamab was granted FDA approval on 21 May 2021, followed by the approval by the EMA on 9 December 2021 and Health Canada on 30 March 2022.

Indication

Amivantamab is indicated in the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.

Associated Conditions
Locally Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
Associated Therapies
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finance.yahoo.com
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Johnson & Johnson reports data from Phase II NSCLC treatment trial

Johnson & Johnson's Phase II SKIPPirr study of IV RYBREVANT in NSCLC patients with EGFR exon 19 deletions or L858R mutations met primary endpoint of reducing infusion-related reactions (IRRs) to 22.5% with dexamethasone prophylaxis, compared to 67.4% historically. All IRRs were Grade 1 or 2, with no hospitalizations or Grade 3+ events reported.
placera.se
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Dexamethasone reduces infusion-related reactions in patients with EGFR-mutated non

Pre-medication with dexamethasone reduces infusion-related reaction rate with intravenous RYBREVANT® by three-fold in EGFR-mutated advanced NSCLC patients.

Related Clinical Trials:

biospace.com
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J&J Challenges AstraZeneca's Tagrisso With Phase III Data for Rybrevant, Lazcluze Combo

Johnson & Johnson's Rybrevant and Lazcluze combo showed a 23% OS benefit over AstraZeneca's Tagrisso in advanced non-small cell lung cancer, with 61% survival at three years versus 53%. The combo also reduced CNS disease risk by 18% and received FDA approval for EGFR-mutated NSCLC.
curetoday.com
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Lazcluze, Rybrevant Approval a 'Big Deal' for EGFR-Mutant NSCLC

Lazcluze plus Rybrevant approved for EGFR-mutant NSCLC, showing 23.7 months median progression-free survival vs. 16.6 months for Tagrisso. Combination offers improved outcomes but with more side effects and requires IV administration. Future research aims to identify optimal patient subsets and develop better drugs.
pipelinereview.com
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RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) show strong favorable ...

Longer-term MARIPOSA study data show RYBREVANT® plus LAZCLUZE™ provides superior outcomes vs osimertinib in first-line EGFR-mutant advanced NSCLC, with a strong OS trend favoring the combination at 3 years.

Related Clinical Trials:

rttnews.com
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Phase 3 Data Show RYBREVANT + LAZCLUZE Outperforms Osimertinib In Non-small

Johnson & Johnson announced that RYBREVANT (amivantamab-vmjw) combined with LAZCLUZE (lazertinib) provided consistent benefits over osimertinib in advanced NSCLC patients with EGFR exon 19 deletions or L858R mutations, with 61% survival at three years compared to 53% for osimertinib. The combination also showed improved central nervous system disease control and longer progression-free survival.
onclive.com
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Dr Spira on Updated MARIPOSA Trial Data in EGFR+ Advanced NSCLC

Alexander Spira discusses MARIPOSA study findings showing amivantamab-vmjw plus lazertinib significantly improves progression-free survival vs osimertinib in EGFR-mutated NSCLC. FDA approved the combination in 2024. Longer-term data from 2024 IASLC World Conference on Lung Cancer indicates potential overall survival benefit with the doublet.
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