Instructions for use of evantumumab

1. Drug name

Drug aliases: evantumab,amivantamab-vmjw, RYBREVANT

Dosage form: injection

Specification:350mg/7mL

Validity period:18 months

Original pharmaceutical manufacturer:JANSSEN BIOTECH

2. Drug indications

1. First-line treatment of non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations: For adult patients with locally advanced or metastatic non-small cell lung cancer who have epidermal growth factor receptor (EGFR) exon 20 insertion mutations confirmed by a U.S. Food and Drug Administration (FDA)-approved test, evantumumab can be used in combination with carboplatin and pemetrexed as a first-line treatment option.

2. Treatment of non-small cell lung cancer treated with EGFR Exon 20 insertion mutation: Evantumumab can be used as a single agent for adult patients with locally advanced or metastatic non-small cell lung cancer with an EGFR exon 20 insertion mutation who have previously received platinum-based chemotherapy and have progressed during or after this period.

3. Medication guidance

1. Preparation before treatment: Doctors will select patients suitable for evantumumab based on the detection results of EGFR exon 20 insertion mutations in tumors or plasma samples. To reduce infusion reactions, patients should be premedicated with antihistamines, antipyretics, and corticosteroids before the first treatment. During subsequent treatment, patients should continue to take antihistamines and fever-reducing medications.

2. Recommended dosage:

(1) Combination medication:

Patients weighing less than 80Kg: Inject 1400mg every week for the first 4 weeks, and 1750mg every 3 weeks starting from the 7th week.

Patients with weight ≥80Kg: 1750mg injected every week for the first 4 weeks, and 2100mg every 3 weeks starting from the 7th week.

(2) Monotherapy:

Patients weighing less than 80Kg: 1050mg injected every week for the first 5 weeks, and 1050mg every 3 weeks starting from the 7th week.

Patients with weight ≥80Kg: 1400mg injected every week for the first 5 weeks, and 1400mg every 3 weeks starting from the 7th week.

3. Dose adjustment: If the patient experiences adverse reactions, the doctor will adjust the drug dosage according to the situation.

4. Possible adverse reactions

In clinical trials of evantumumab, common adverse reactions (≥20%) include rash, infusion reactions, nail problems (such as paronychia), musculoskeletal pain, dyspnea, nausea, edema, cough, fatigue, etc. In addition, some laboratory test abnormalities may occur, such as changes in gamma glutamyl transferase, sodium, potassium and other indicators.

5. Drug Storage and Supply

Evantumumab injection is a colorless to light yellow sterile intravenous infusion solution. Each bottle contains350 mg of the drug. Medications should be stored in a refrigerator at 2°C to 8°C, away from light, and not frozen.

6. Precautions for special users

Female patients: According to animal experimental data, evantumumab may cause harm to pregnant women and fetuses. Therefore, it is recommended that women of childbearing potential take effective contraceptive measures during treatment and within 3 months after stopping the drug. At the same time, breastfeeding women should suspend breastfeeding during treatment and within 3 months after stopping the drug.

7. Drug action mechanism

Evantumumab is a bispecific antibody that simultaneously bindsEGFR and MET. It disrupts the signaling functions of EGFR and MET by blocking ligand binding and promotes the degradation of EGFR and MET in models with exon 20 insertion mutations. In addition, the drug can guide immune effector cells to attack tumor cells through antibody-dependent cytotoxicity and macrophage exocytosis mechanisms.