How does Rybrevant work?

Rybrevant is a targeted medicine that works at the epidermal growth factor receptor (EGFR) gene mutation and MET receptor found in certain types of non-small cell lung cancer (NSCLC). EGFR and MET are proteins that help cancer cells to grow. Targeting these proteins helps to slow down or stop cancer growth.

A mutation (change) in the gene for EGFR can make it grow and lead to cancer. This mutation is one change that your doctor may look for in NSCLC. Rybrevant also helps your immune system to identify cancer cells with EGFR and destroy them.

Rybrevant is considered a monoclonal antibody, which is an immune system protein made in the laboratory. It targets two proteins that fuel cancer cell growth: EGFR and MET and is considered a "bispecific" antibody.

What does Rybrevant treat?

Rybrevant (amivantamab-vmjw) can be used alone as a single medicine in adults with EGFR-positive NSCLC that cannot be removed by surgery or has spread to other parts of the body (metastatic), and has not responded to platinum-based treatments.

It is also used in combination with chemotherapy (carboplatin and pemetrexed) as a first-line (initial) treatment for adults with EGFR-positive NSCLC that cannot be removed by surgery or has spread to other parts of the body (metastatic).

Your doctor can perform a blood test (called a biomarker test) approved by the FDA to make sure the cancer has the EGFR mutation and you can receive Rybrevant.

How do I receive Rybrevant?

Rybrevant is either given alone or in combination with two chemotherapy drugs called pemetrexed and carboplatin for the treatment of EGFR-positive NSCLC.

It is given as an intravenous (IV) infusion into your vein, usually in an infusion clinic. Your healthcare provider will determine your dose based on your body weight. You may receive medications before your infusion (antihistamines, fever-reducing medicines and steroids) to help prevent infusion-related reactions from your treatment. Your doctor will monitor you closely.

After initial dosing schedule over the first 6 weeks, you will receive Rybrevant IV infusions either every 2 or 3 weeks. It is usually given until your disease worsens or you have side effects that require you to stop treatment.

Learn more: Dosing for Rybrevant (in more detail)

Is Rybrevant a chemo drug?

No, Rybrevant (amivantamab-vmjw) is not chemotherapy ("chemo"). It is a targeted drug treatment known as a bispecific EGF receptor-directed and MET receptor-directed antibody used to treat certain types of non-small cell lung cancer with an EGFR gene mutation. Because it binds to two proteins, it’s called a "bispecific" monoclonal antibody. A monoclonal antibody is a lab-made version of a specific immune system protein.

It targets two proteins that help cancer cells grow: EGFR and MET. It is not considered a chemotherapy or an immunotherapy, but is a targeted drug that works specifically at these mutations.

How long does Rybrevant work?

CHRYSALIS: Previously treated NSCLC with EGFR exon 20 insertion mutations

In the CHRYSALIS study looking at Rybrevant treatment alone (without chemotherapy), the median duration of response was 11.1 months, with 63% of people having a duration of response lasting 6 months or longer.

• The CHRYSALIS study included 81 patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease had progressed on or after platinum-based chemotherapy.
• In this population, the median age was 62, 59% were female and 53% of patients had never smoked, 46% had received prior immunotherapy and the median number of prior therapies was 2 (ranging from 1 to 7).
• Patients received Rybrevant monotherapy at 1050 mg once weekly for 4 weeks, then every 2 weeks thereafter until disease progression or unacceptable toxicity.
• The overall response rate (ORR) was 40%, with 3.7% of patients having a complete response* and 36% achieving a partial response. The median duration of response (DOR) was 11.1 months, with 63% of people having a duration of response lasting at least 6 months.

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PAPILLON: First-line treatment of NSCLC with EGFR exon 20 insertion mutations

In the open-label, Phase 3 PAPILLON study of Rybrevant for first-line treatment of NSCLC with EGFR exon 20 mutations, the median duration of response (DOR) was 10.1 months in the group receiving Rybrevant plus chemotherapy, compared to 5.6 months in the group receiving chemotherapy alone.

• The PAPILLON study included 308 patients with previously untreated locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.
• Participants received IV infusions of Rybrevant in combination with chemotherapy (carboplatin and pemetrexed) or chemotherapy alone. Dosing is outlined in the product information. In this population, the median age was 62, 58% were female, 58% of patients had never smoked, and 84% had Stage IV cancer at initial diagnosis.
• The primary efficacy outcome measure was progression-free survival (PFS). Rybrevant + chemotherapy demonstrated a statistically significant improvement in PFS for patients in the Rybrevant + chemotherapy group (11.4 months) compared to those receiving only chemotherapy (6.7 months). Rybrevant plus chemotherapy resulted in a 61% reduction in the risk of disease progression or death compared to chemotherapy alone.
• The overall response rate (ORR) was 67% in the Rybrevant + chemotherapy vs. 36% with chemotherapy alone (with a 4% complete response* and a 63% partial response in the Rybrevant + chemotherapy group).
• The median duration of response (DOR) was 10.1 months in the Rybrevant + chemotherapy group, compared to 5.6 months in those receiving chemotherapy alone.

*It's important to note that the disappearance of all signs of cancer in response to treatment (complete response) does not always mean the cancer has been cured.

What side effects can occur with Rybrevant?

Before you start treatment, discuss side effects with your doctor.

Rybrevant may cause serious side effects such as infusion-related reactions, interstitial lung disease / pneumonitis, severe skin reactions, and eye problems.

Common side effects when Rybrevant is used alone includes rash, muscle and joint pain, infusion reactions, nail infections, shortness of breath, constipation, cough, fatigue, edema, stomatitis (mouth sores), and nausea and vomiting.

When Rybrevant is given with chemotherapy, common side effects include: rash, nail toxicity, stomatitis (mouth sores), infusion reactions, fatigue, edema, constipation, decreased appetite, nausea, COVID-19, diarrhea, and vomiting.

Laboratory abnormalities may also occur.

Related: Rybrevant side effects (in more detail)

This is not all the information you need to know about Rybrevant (amivantamab-vmjw) for safe and effective use and does not take the place of your healthcare provider's directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.