Amivantamab, sold under the brand name Rybrevant, is a bispecific monoclonal antibody used to treat non-small cell lung cancer.
It is a bispecific epidermal growth factor (EGF) receptor-directed and mesenchymal–epithelial transition (MET) receptor-directed antibody.
It is the first treatment for adults with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
It targets both Epidermal Growth Factor Receptor (EGFR) and MET receptors to inhibit tumor growth and activate immune cells.
The use of Amivantamab plus chemotherapy resulted in superior efficacy, as compared with chemotherapy alone as first line treatment of patients with advanced NSCLC with EGFR exon 20 insertions (PAPILLON, investigators).
Targets Epidermal growth factor receptor (EGFR) and Mesenchymal–epithelial transition (MET).
The mechanism of action is multi targeted and includes ligand receptor degradation, and engagement of immune factor cells through optimized Fc domain, and the antibody is shown single agent activity against both EGFR driven NSCLC and MET driven NSCLC.
Pregnancy category AU: D
Routes of administration-Intravenous infusion.
It is given via intravenous (IV) infusion by a healthcare professional.
Approval: Approved by the FDA for EGFR exon 20 insertion mutations and subsequent combinations for exon 19/21 mutations.
The most common side effects include rash, infusion-related reactions, skin infections around the fingernails or toenails, muscle and joint pain, shortness of breath, nausea, fatigue, swelling in the lower legs or hands or face, sores in the mouth, cough, constipation, vomiting and changes in certain blood tests.
Amivantamab is indicated for the treatment of adults 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.
The most common side effects include rash, infusion-related reactions, infected skin around the nail, muscle and joint pain, shortness of breath, nausea, feeling very tired, swelling of hands, ankles, feet, face, or all of your body, sores in the mouth, cough, constipation, vomiting, and decreased albumin levels, increased glucose levels, and increased liver enzymes.
Amivantamab may cause serious side effects including infusion-related reactions, lung inflammation, skin problems, eye problems, and harm to an unborn baby.
CHRYSALIS, a multicenter, non-randomized, open label, multicohort clinical trial included participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.
Efficacy was evaluated in 81 participants with advanced NSCLC with EGFR exon 20 insertion mutations whose disease had progressed on or after platinum-based chemotherapy.
The overall response rate was 40%, with a median duration of response of 11.1 months, and a median progression-free survival of 8.3 months.
Amivantamab-lazertinib treatment leads to significantly longer overall survival among patients with untreated EGFR muted advanced NSCLC than osimetrinib but is associated with increased risk of adverse events.
Amivantamab plus lazertinib treatment in combination for the first line treatment of adult patients with locally advanced metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21L858R substitution mutations as detected by FDA approved test reveal superior overall survival versus Osimertinib.
Common Side Effects: Rash, infusion-related reactions, nail issues, fatigue, and swelling.
Skin Reactions: Rashes (acneiform dermatitis) are common, occurring in up to 74% of patients, requiring sun protection and sometimes topical treatments.
Infusion Reactions: common often during the first infusion and include fever, nausea, and shortness of breath.
Other Side Effects includeConstipation, diarrhea, and infections.
Patients must undergo testing to confirm EGFR exon 20 insertion mutations or 19/21 deletions before starting this therapy.