Bevacizumab-awwb (Mvasi)

How is this drug name pronounced?

Bevacizumab: beh-vuh-SIH-zoo-mab

Mvasi: em-VAH-see

Mvasi (bevacizumab-awwb) is “biosimilar” to Avastin (bevacizumab). Mvasi has been shown to be similar to Avastin in the way it works, how well it works, and how safe it is. Another approved drug that is biosimilar to Avastin is Zirabev (bevacizumab-bvzr).


What cancer(s) does this drug treat?

Mvasi has been approved for a number of cancer types and stages, in some cases as a single therapy, and in some cases in combination with other therapies.

Mvasi is approved for:

Colorectal cancer
Non-small cell lung cancer
Glioblastoma
Kidney cancer
Cervical cancer

Advanced colorectal cancer

Mvasi is approved for:

  • Patients with colon or rectal cancer that has spread to other parts of the body. In such cases, Mvasi is used in combination with intravenous chemotherapy containing fluorouracil as a first treatment for patients with previously untreated advanced disease, or as a second treatment for patients with previously treated advanced disease.
  • Patients with colon or rectal cancer that has spread and who have received treatment containing bevacizumab (Mvasi, Avastin, Zirabev) and chemotherapy, and the treatment did not work or stopped working. In such cases, Mvasi is used in combination with chemotherapy containing fluoropyrimidine and either irinotecan (Onivyde or Camptosar) or oxaliplatin (Eloxatin), depending on the chemotherapy initially used.

Advanced non-small cell lung cancer

Mvasi is approved for:

  • Patients with nonsquamous non-small cell lung cancer that has grown, come back, or spread and cannot be removed by surgery, and who have not received chemotherapy for their advanced disease. In such cases, Mvasi is used in combination with paclitaxel (Taxol or Onxal) and carboplatin (Paraplatin) as a first treatment.

Glioblastoma

Mvasi is approved for:

  • Patients with glioblastoma that has come back or gotten worse after previous treatment.

Advanced kidney cancer

Mvasi is approved for:

  • Patients with advanced renal cell carcinoma (kidney cancer) that has spread. In such cases, Mvasi is used in combination with interferon alfa.

Advanced cervical cancer

Mvasi is approved for:

  • Patients with cervical cancer that has not responded to previous treatment, has come back, or has spread. In such cases, Mvasi is used in combination with paclitaxel (Taxol or Onxal) and either cisplatin (Platinol) or topotecan (Hycamtin).

Limitations of use:

Age: The safety and efficacy of Mvasi in patients under 18 years of age have not been established.
Fertility/Pregnancy/Breastfeeding: Mvasi can cause ovaries to stop working and impair the ability to have children. Mvasi can cause harm to a fetus, and is not recommended for use during pregnancy. Pregnancy should be prevented for at least six months after the last dose of Mvasi. The risks associated with Mvasi during breastfeeding are not known and cannot be ruled out. Due to the potential for serious adverse reactions in the breastfed child, women are advised not to breastfeed during treatment and for at least six months after the last dose of Mvasi.


What type of immunotherapy is this?

Antibody therapy

  • Angiogenesis inhibitor

How does this drug work?

  • Target: vascular endothelial growth factor (VEGF)

Mvasi is an antibody that attaches to a protein molecule called vascular endothelial growth factor (VEGF). VEGF stimulates the formation of new blood vessels and promotes growth of preexisting blood vessels – a process called angiogenesis. In a healthy body, VEGF is produced by many different types of cells and helps to create new blood vessels during embryonic development, normal growth of tissues, and wound healing. Tumors make higher than normal amounts of VEGF because the formation of new blood vessels within the tumor is critical for the cancer to grow (by providing the tumor with access to oxygen and other nutrients) and to spread to other parts of the body (by providing a route for cancer cells to enter blood circulation and move to other locations). VEGF molecules produced by tumors bind to molecules called VEGF receptors that are present on cells found in the inside lining of blood vessels (endothelial cells). The binding of VEGF to VEGF receptors leads the endothelial cells to multiply, migrate to the source of the VEGF molecules (the tumor site), and form new blood vessels within the tumor.

Mvasi binds to the VEGF molecules within blood vessels in a way that blocks the interaction between VEGF and the VEGF receptors on endothelial cells. This helps prevent the formation of new blood vessels within the tumor, thus starving the tumor of oxygen and other nutrients, and preventing its growth.

How Mvasi works


How is this drug given to the patient?

Mvasi is administered via a tube into a vein (intravenous infusion, or I.V.) every two or three weeks (depending on the cancer type) and does not require a hospital stay. The first infusion is administered over 90 minutes. If the first infusion is tolerated, the second infusion is administered over 60 minutes. If the second infusion is tolerated, all following infusions are administered over 30 minutes.

Mvasi should not be administered for at least 28 days after surgery, and only after the surgical wound is fully healed.


What are the observed clinical results?

For:

Advanced colorectal cancer (previously untreated or treated)
Advanced non-small cell lung cancer
Glioblastoma
Advanced kidney cancer
Advanced cervical cancer

It is important to keep in mind that each patient’s actual outcome is individual and may be different from the results found in the clinical studies. In addition, with immunotherapy, sometimes it takes several months for responses to be observed.

Advanced colorectal cancer (previously untreated or treated)

In a clinical trial, 923 patients with previously untreated advanced colorectal cancer that had spread were treated with:

  • Avastin (Mvasi is equivalent to Avastin) plus irinotecan (Onivyde or Camptosar), fluorouracil, and leucovorin, OR
  • Avastin plus fluorouracil and leucovorin, OR
  • Placebo plus irinotecan, fluorouracil, and leucovorin.

Prognosis Avastin vs placebo (diagram)

In another clinical trial, 829 patients with advanced colorectal cancer that had spread, and who had been previously treated with irinotecan (Onivyde or Camptosar) and fluorouracil, were treated with:

  • Avastin (Mvasi is equivalent to Avastin) plus oxaliplatin (Eloxatin), fluorouracil, and leucovorin, OR
  • oxaliplatin, fluorouracil, and leucovorin, OR
  • Avastin alone.

At a median follow-up of 28 months:

Prognosis Avastin and chemo vs chemo alone vs Avastin alone (diagram)

In another clinical trial, 820 patients with advanced colorectal cancer that had spread, who had previously received Avastin-containing treatment (Mvasi is equivalent to Avastin), and it either did not work or stopped working, were treated with either Avastin plus chemotherapy (fluoropyrimidine with either irinotecan (Onivyde or Camptosar) or oxaliplatin (Eloxatin)) or chemotherapy alone.

Prognosis Avastin and chemo vs chemo alone (diagram)

Advanced non-small cell lung cancer

In a clinical trial, 878 patients with nonsquamous non-small cell lung cancer that had grown, spread, or come back, and who had not received chemotherapy for their advanced disease, were treated with either Avastin (Mvasi is equivalent to Avastin) plus chemotherapy (paclitaxel (Taxol or Onxal) and carboplatin (Paraplatin)) or chemotherapy (paclitaxel and carboplatin) alone.

Prognosis Avastin and chemo vs chemo alone for lung cancer (diagram)

Glioblastoma

In a clinical trial, 432 patients with recurrent glioblastoma (glioblastoma that had come back or gotten worse after previous treatment) were treated with either Avastin (Mvasi is equivalent to Avastin) in combination with the chemotherapy drug lomustine (Gelostine) or with lomustine alone. The disease did not get worse for a median of 4 months for patients treated with Avastin plus lomustine, compared with 2 months for patients treated with lomustine alone. There was no difference in overall survival. Among patients requiring corticosteroids at the beginning of the study, 23% of patients receiving Avastin plus lomustine were able to stop taking corticosteroids, compared with 12% of patients receiving lomustine alone.

In two other clinical trials, patients with previously treated glioblastoma were treated with Avastin (Mvasi is equivalent to Avastin). In one trial, 26% of 85 patients responded to treatment, and patients continued to respond for a median of 4 months. In the other trial, 20% of 56 patients responded to treatment (saw their cancer shrink), and patients continued to respond for a median of 4 months.

Advanced kidney cancer

In a clinical trial, 649 patients with previously untreated advanced renal cell carcinoma (kidney cancer) that had spread were treated with either Avastin (Mvasi is equivalent to Avastin) and interferon alfa or placebo and interferon alfa. For patients treated with Avastin and interferon alfa, the disease did not get worse for a median of 10 months, compared with 5 months for patients treated with placebo and interferon alfa. Of the 595 patients with measurable disease, 31% of patients treated with Avastin and interferon alfa responded to treatment (saw their cancer shrink), compared with 12% of patients responding to placebo and interferon alfa.

Advanced cervical cancer

In a clinical trial, 452 patients with cervical cancer that had not responded to previous treatment, had come back, or had spread, were treated with:

  • Avastin (Mvasi is equivalent to Avastin) with chemotherapies paclitaxel (Taxol or Onxal) and cisplatin (Platinol), OR
  • Avastin with chemotherapies paclitaxel and topotecan (Hycamtin), OR
  • chemotherapies paclitaxel and cisplatin,OR
  • chemotherapies paclitaxel and topotecan.

Prognosis for cervical cancer treated with Avastin and chemo vs chemo alone (diagram)


What are the side effects?

The most common side effects of Mvasi include high blood pressure, nosebleeds, rectal bleeding, diarrhea, abdominal (belly) pain, back pain, headache, fatigue, weakness, taste change, dry skin, inflammation of the skin, inflammation of the nose, watery eyes, and too much protein in the urine.

Mvasi can cause side effects that can become serious or life-threatening, and may lead to death. Some of the serious side effects related to Mvasi include development of a hole in the stomach or intestine, formation of an abnormal connection between two body parts (a fistula), blood clots, serious bleeding, having wounds that do not heal, and severe high blood pressure. Additionally, problems can arise with the kidneys, the heart, the nervous system, and vision. Reactions related to the infusion may also occur. Patients should report any symptoms to their healthcare provider, who can then initiate actions to limit or reverse the side effects.

For a more complete list of possible side effects, see the full prescribing information.


Additional information

Manufacturer

Amgen

Approval

FDA and EMA

US: https://www.mvasi.com/patient/what-is-mvasi Europe: https://www.ema.europa.eu/en/medicines/human/EPAR/mvasi

Other references


Understanding Cancer Immunotherapy Research

Search