Efficacy of Binimetinib

In the COLUMBUS trial in unresectable or metastatic melanoma, 577 patients were randomized (1:1:1) to receive: Binimetinib 45 mg twice daily plus canafenib b) 450 mg once daily, or canafenib 300 mg twice daily, or vemurafenib 960 mg three times daily, with treatment continued until disease progression or unacceptable side effects.

The primary outcome for patients who received bimetinib plus canafenib was median progression-free survival (PFS) of 14.9 months compared with 7.3 months for patients who received vemurafenib monotherapy. PFS is the length of time, during and after cancer treatment, that a patient lives with the disease without getting worse. In this case, 50% had a PFS of less than 14.9 months and 50% had a PFS of greater than 14.9 months. The overall response rate was 63% for bimetinib + canelfenib and 40% for vemurafenib monotherapy. The median duration of response was 16.6 months and 12.3 months respectively. The most common side effects (≥25%) were fatigue, vomiting, nausea, stomach (abdominal) pain, and diarrhea.

Approval in non-small cell lung cancer is based on data from the ongoing, open-label, single-arm Phase 2 PHAROS clinical trial with 98 participants. Researchers are examining the combination of bimetinib and canafenib in patients with BRAF V600E-mutated metastatic non-small cell lung cancer. Patients received bimetinib 45 mg orally twice daily and canafenib 450 mg orally once daily until disease progression or unacceptable side effects occurred.

For the 59 patients who had never received any treatment for lung cancerthe overall response rate was 75%, with 59% of patients in remission for at least 12 months. At data cutoff, the median duration of response in this group could not be estimated. For the 39 previously treated patients, the overall response rate was 46%, with 33% of patients in response for at least 12 months. The median duration of response was 16.7 months. The median treatment duration of bimetinib+canafenib is 8.4 and 9.2 months. The most common side effects (≥25%) are fatigue, blurred vision, blindness or other vision changes, nausea, vomiting, constipation, diarrhea, shortness of breath, muscle or joint pain, rash, cough, stomach (abdominal) pain.

The original drug bimetinib has not yet been launched in China, and therefore is not covered by medical insurance. Bimetiniboriginal drug sold overseas, specifications15mg*84 tablets may cost more than 10,000 yuan per box (the price may fluctuate due to exchange rates), which is relatively expensive. There is currently no generic drug of Bimetinib produced and launched. For more drug information and specific prices, please consult a medical consultant.