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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oncnursingnews.com
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FDA Approves Amivantamab-Chemo Combo for Advanced NSCLC

FDA approves amivantamab-vmjw (Rybrevant) plus carboplatin and pemetrexed for advanced/metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, post-EGFR TKI progression. MARIPOSA-2 trial shows 6.3 months median PFS vs 4.2 months with chemotherapy alone, 53% overall response rate vs 29%. No significant OS difference noted. Common adverse effects include rash, infusion-related reactions, fatigue, and COVID-19 infection.
drugs.com
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Rybrevant (amivantamab-vmjw) Plus Standard of Care Approved in the U.S. as First and Only Targeted Regimen to Cut Risk of Disease Progression by More Than Half in Second-Line EGFR-Mutated Advanced Lung Cancer

FDA approves Rybrevant (amivantamab-vmjw) plus chemotherapy for EGFR-mutated advanced NSCLC, reducing disease progression risk by 52%.

Related Clinical Trials:

pharmaphorum.com
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ESMO: J&J cues up phase 3 for Rybrevant in colorectal cancer

Johnson & Johnson plans phase 3 trials for Rybrevant in colorectal cancer after phase 1b/2 OrigAMI-1 study showed 49% ORR in RAS/BRAF wild-type mCRC patients, with 7.4 months median duration of response and 88% disease control rate. Rybrevant also achieved 53% ORR in liver-metastasized cases, with 21% eligible for curative surgery.
janssen.com
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RYBREVANT® (amivantamab-vmjw) plus chemotherapy show 49 percent overall response

RYBREVANT® (amivantamab-vmjw) combined with chemotherapy showed promising antitumor activity in RAS/BRAF wild-type metastatic colorectal cancer patients not previously treated with EGFR therapy, with a median duration of response of 7.4 months. 21% of patients underwent curative-intent surgery, and the safety profile was manageable without new safety signals.

Related Clinical Trials:

prnewswire.com
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RYBREVANT® (amivantamab-vmjw) plus chemotherapy shows positive overall survival

Updated MARIPOSA-2 study results show RYBREVANT® plus chemotherapy significantly improves post-progression outcomes in previously treated NSCLC patients with EGFR exon 19 deletions or L858R mutations, with a favorable trend toward improved overall survival compared to chemotherapy alone. Data presented at ESMO 2024 Congress.

Related Clinical Trials:

biocentury.com
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Rybrevant shows colorectal cancer promise in latest bispecifics win

J&J's Rybrevant shows promise in colorectal cancer, with Phase II data suggesting it makes metastatic patients eligible for curative surgery, leading to a 49% ORR in the OrigAMI-1 study.
prnewswire.com
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RYBREVANT® (amivantamab-vmjw) plus chemotherapy show 49 percent overall ...

RYBREVANT® (amivantamab-vmjw) + chemotherapy showed promising antitumor activity in RAS/BRAF WT mCRC patients not previously treated with anti-EGFR therapy, with a median duration of response of 7.4 months. 21% of patients proceeded to curative-intent surgery.

Related Clinical Trials:

menafn.com
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RYBREVANT® (Amivantamab-Vmjw) Plus Chemotherapy Shows Positive Overall Survival

RYBREVANT® plus standard of care showed significant and sustained improvement over chemotherapy alone in post-progression outcomes for previously treated NSCLC patients with EGFR exon 19 deletions or L858R mutations, with a favorable trend toward improved overall survival.

Related Clinical Trials:

Johnson & Johnson's TREMFYA gains FDA approval

Johnson & Johnson's TREMFYA (guselkumab) approved by FDA for treating adults with moderately to severely active ulcerative colitis (UC). TREMFYA, a fully human monoclonal antibody, blocks IL-23 and binds to CD64, administered intravenously with a 200mg induction dose at weeks zero, four, and eight, followed by subcutaneous maintenance doses every eight or four weeks. The approval is based on the Phase II/III QUASAR study, showing 50% and 45% clinical remission rates at week 44 for 200mg and 100mg doses respectively, compared to 19% for placebo. TREMFYA now has three indications, including moderate-to-severe plaque psoriasis and active psoriatic arthritis.
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