Array BioPharma (ARRY) Reports Encouraging Data from MEK162 in Ongoing Phase 2
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Promising data on MEK162 in an ongoing Phase 2 trial of patients with BRAF and NRAS mutated advanced melanoma was presented today at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. MEK162, a small molecule selective inhibitor of the kinases MEK1 and MEK2, showed clinical activity and good tolerability in this patient population. This is the first targeted therapy to show activity in patients with NRAS mutated melanoma.
Array BioPharma Inc. (Nasdaq: ARRY) invented MEK162 and licensed worldwide rights to develop and commercialize MEK162 to Novartis in April 2010. The ongoing Phase 2 open-label trial is being conducted by Novartis and continues to enroll patients.
Since February 2012, the study has shown that, of the 35 patients with BRAF mutations evaluable for response, eight had partial responses, including two confirmed partial responses and 13 patients demonstrated stable disease. The disease control rate was 60 percent among these patients with at least two scans. Of the 28 patients with NRAS mutations who were evaluable for response, six had partial responses, including three confirmed partial responses and 13 patients demonstrated stable disease. The disease control rate was 68 percent among these patients with at least two scans. The median progression-free survival was 3.55 months [95% CI 2.00 – 3.81 months] for patients with BRAF mutation and 3.65 months [95% CI 2.53 - 5.39 months] for patients with NRAS mutations.
Common adverse events of all grades were consistent with data reported for the MEK inhibitor class and included rash, diarrhea, acneiform dermatitis, edema, creatine phosphokinase elevation, central serous retinopathy-like events, nausea, and fatigue.
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Array BioPharma Inc. (Nasdaq: ARRY) invented MEK162 and licensed worldwide rights to develop and commercialize MEK162 to Novartis in April 2010. The ongoing Phase 2 open-label trial is being conducted by Novartis and continues to enroll patients.
Since February 2012, the study has shown that, of the 35 patients with BRAF mutations evaluable for response, eight had partial responses, including two confirmed partial responses and 13 patients demonstrated stable disease. The disease control rate was 60 percent among these patients with at least two scans. Of the 28 patients with NRAS mutations who were evaluable for response, six had partial responses, including three confirmed partial responses and 13 patients demonstrated stable disease. The disease control rate was 68 percent among these patients with at least two scans. The median progression-free survival was 3.55 months [95% CI 2.00 – 3.81 months] for patients with BRAF mutation and 3.65 months [95% CI 2.53 - 5.39 months] for patients with NRAS mutations.
Common adverse events of all grades were consistent with data reported for the MEK inhibitor class and included rash, diarrhea, acneiform dermatitis, edema, creatine phosphokinase elevation, central serous retinopathy-like events, nausea, and fatigue.
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