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Ema Chmp recommended the approval of a BRAF inhibitor, encorafenib, in combination with an MEK inhibitor, binimetinib, for the treatment of adult patients with melanoma with mutations BRAFV600 non-insoluble or metastatic. [19659002] Ema Chmp recommended the approval of a BRAF inhibitor, encorafenib, in combination with an MEK inhibitor, binimetinib, for the treatment of adult patients with melanoma presenting with non-insoluble or metastatic BRAFV600 mutation. The CHMP recommendation will now be considered by the European Commission for the final decision scheduled for late September.
The drug was originally developed by American biotech Array Pharma. Pierre Fabre has the exclusive right to market both products in Europe, Asia and Latin America.
The positive opinion of the Chmp is based on the results of the COLUMBUS Phase 3 study, which showed that the combination of the two drugs median progression-free survival (mPFS) of nearly 15 months [14,9 mesi rispetto alla monoterapia con vemurafenib a 7,3 mesi; rapporto di rischio (HR) 0,54 (95% CI, 0,41-0,71), p<0,0001].
In June 2018, Array also announced the updated results of the COLUMBUS study, which showed that the combination of the two drugs was the first targeted therapy to achieve more than 30 months of overall survival (SG) in a phase study. 3 and reduces the risk of death compared with treatment with vemurafenib [HR (0.61), (95% CI 0.47-0.79, p <0.0001]. Median overall survival was 33.6 months in patients treated with the combination, compared to 16.9 months in patients treated with vemurafenib alone.
"Despite recent progress, there remains a significant unmet need for both effective and well-tolerated treatment for melanoma patients with BRAF mutations – says Paolo Ascierto, Director of the Unit for Disease Prevention and Control. Melanoma Oncology, Immunotherapy Oncology and Innovative Therapies of the National Cancer Institute & # 39; G. Pascale & # 39; Naples – Doctors and Patients Now Have an Additional Option in Treatment Due to the Combination of encorafenib and binimetinib, which has been shown to delay the progression of the disease and improve overall survival, while generally being well tolerated. "
is of extreme interest: indeed, with the other badociations of BRAF inhibitors and MEK inhibitors, the median survival is about 22 months, similar to that seen in the arm treated with 300 mg of "coforafenib" he stressed Congress ASCO Paola Queirol o, from the Policlinico San Martino di Genova. "A median of 10 months more survival than other combinations gives us hope for a longer benefit from this combination than those already tested, which have become a standard for melanoma treatment in an advanced phase." ", adds the Italian expert
The most common grade 3-4 adverse events observed in more than 5% of patients were the increase in gamma-glutamyltransferase (9%), the most common Increased creatine phosphokinase in the blood (7%) and hypertension (6%).
In the United States, both drugs are approved for the treatment of non-resorbable or metastatic melanomas with BRAFV600E or BRAFV600K mutations, as detected by an FDA-approved test.
Only 5% of patients who received treatment with both drugs discontinued treatment due to adverse effects. The most common adverse events (≥25%) were fatigue, nausea, diarrhea, vomiting, abdominal pain and arthralgia
COLUMBUS study information
L & # 39; COLUMBUS trial is a two-part open-label randomized trial that evaluated the efficacy and safety of the combination of coforafenib and binimetinib compared to vemurafenib or encorafenib monotherapy in 921 patients with diabetes mellitus. 39; a locally unresectable or metastatic melanoma carrying the mutation BRAFV600E or BRAFV600K, enrolled in 200 centers located in North America, Europe, South America, Africa, Asia and Australia. Participants were required to have a performance index of 0 or 1 and were either naive to treatment or progressed after first-line immunotherapy.
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