What is Mektovi used to treat?
Mektovi is used in combination with another medicine called encorafenib (Braftovi) to treat advanced forms of melanoma (skin cancer) and non-small cell lung cancer (NSCLC) with certain BRAF gene mutations.
Mektovi is used in combination with encorafenib to treat:
- Patients with unresectable or metastatic melanoma (skin cancer that cannot be removed by surgery or has spread) with a BRAF V600E or V600K gene mutation.
- Adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation.
- These gene mutations are detected in tumor specimens with an FDA-approved test prior to using Mektovi.
Mektovi (binimetinib) from Array BioPharma, along with Braftovi (encorafenib), is part of an oral BRAF/MEK inhibitor combination therapy. Both Braftovi and Mektovi are oral, small molecule kinase inhibitors.
Roughly 50% of patients diagnosed with metastatic melanoma test positive for the BRAF mutation, and it is the most common genetic mutation in metastatic melanoma. BRAF mutations are rare in non-small cell lung cancer (NSCLC), occurring in 2% to 5% of cases.
Studies for Mektovi
Melanoma (advanced skin cancer)
In the COLUMBUS trial of unresectable or metastatic melanoma, 577 patients were randomized (1:1:1) to receive:
- binimetinib (Mektovi) 45 mg twice daily plus encorafenib (Braftovi) 450 mg once daily
- encorafenib (Braftovi) 300 mg once daily, or
- vemurafenib (Zelboraf) 960 mg twice daily.
Treatment continued until disease progression or unacceptable side effects.
The primary outcome, median progression-free survival (PFS), was 14.9 months for patients receiving the Braftovi + Mektovi combination, compared to 7.3 months for vemurafenib (Zelboraf) monotherapy. PFS is the length of time during and after the treatment of the cancer that a patient lives with the disease but it does not get worse. In this case, 50% of the people had a PFS less than 14.9 months, and 50% had a PFS longer than 14.9 months.
Overall response rates were 63% for Braftovi + Mektov and 40% for vemurafenib (Zelboraf) monotherapy. Median duration of response was 16.6 months vs. 12.3 months, respectively.
In studies, the most common side effects (≥25%) in people being treated for melanoma with Braftovi + Mektovi were:
- stomach-area (abdominal) pain
Non-small cell lung cancer (NSCLC)
Approval for NSCLC was based on data from the ongoing, open-label, single arm Phase 2 PHAROS clinical trial with 98 participants. Researchers are examining Braftovi + Mektovi combination therapy in patients with BRAF V600E-mutant metastatic NSCLC.
Patients received Mektovi 45 mg orally twice daily and encorafenib (Braftovi) 450 mg once daily until disease progression or unacceptable side effects occurred.
- For 59 patients who have never received any treatment for their lung cancer, the overall response rate was 75% and 59% of the patients responded for at least 12 months. Median duration of response was not yet estimable for this group at the time of data cutoff.
- For 39 patients who had previously received treatment, the overall response rate was 46% and 33% of the patients responded for at least 12 months. The median duration of response was 16.7 months.
- The median duration of treatment for Mektovi and encorafenib (Braftovi) was 8.4 and 9.2 months respectively.
In studies, the most common side effects (≥25%) in people being treated for NSCLC with Braftovi + Mektovi were:
- blurred vision, loss of vision, or other vision changes
- nausea, vomiting
- shortness of breath
- muscle or joint pain
- stomach-area (abdominal) pain
Review Mektovi warnings, side effects and drug interactions in more detail here.
This is not all the information you need to know about Mektovi (binimetinib) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other healthcare provider.
- Mektovi (binimetinib). Array BioPharma. Revised October 2023. Accessed October 16, 2023 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210498s009lbl.pdf
- FDA Approves Mektovi (binimetinib) and Braftovi (encorafenib) in Combination for Unresectable or Metastatic Melanoma with BRAF Mutations. Drugs.com. Accessed Oct 16, 2023 at https://www.drugs.com/newdrugs/fda-approves-mektovi-binimetinib-braftovi-encorafenib-combination-unresectable-metastatic-melanoma-4772.html
- FDA Approves Braftovi (encorafenib) with Mektovi (binimetinib) for Metastatic Non-Small Cell Lung Cancer with a BRAF V600E Mutation. Drugs.com. Accessed Oct 16, 2023 https://www.drugs.com/newdrugs/fda-approves-braftovi-encorafenib-mektovi-binimetinib-metastatic-non-small-cell-lung-cancer-braf-6111.html
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