Array Biopharma (ARRY) Reaches Agreement with FDA on Phase 3 BEACON CRC SPA

September 14, 2016 7:37 AM EDT

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Array BioPharma (Nasdaq: ARRY) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) related to BEACON CRC, a global Phase 3 trial of encorafenib and Erbitux® (cetuximab), with or without binimetinib, versus standard of care in patients with BRAF-mutant colorectal cancer (CRC) who have previously received first-or second-line systemic therapy.

"Colorectal cancer is the third most common cancer among men and women in the United States and BRAF-mutant CRC represents a high unmet medical need, as there are currently no targeted treatment options available for patients with this form of the disease," said Scott Kopetz, M.D., Ph.D., of the University of Texas MD Anderson Cancer Center in Houston and BEACON CRC investigator. "The SPA agreement between Array and the FDA represents a welcome next step for the CRC community and, as a physician, I look forward to exploring these novel treatment combinations."

The SPA provides agreement that the design and planned analysis of BEACON CRC adequately address the objectives necessary to support a regulatory submission for the approval of the doublet regimen of encorafenib and Erbitux®. The FDA also communicated that sharing evidence from the study that the triplet regimen (encorafenib, Erbitux and binimetinib) both met its primary endpoint (Overall Survival) as compared to the control arm, and demonstrated a clinically meaningful benefit as compared to the doublet regimen, would provide support for approval of the triplet regimen.

Trial Design

BEACON CRC is a randomized, open-label, global study evaluating the efficacy and safety of encorafenib and Erbitux, with or without binimetinib, in patients with BRAF-mutant metastatic CRC who have previously received first-or second-line systemic therapy. The study includes a safety lead-in with approximately 30 patients. With appropriate results from the lead-in, approximately 615 patients are expected to be randomized 1:1:1 to receive triplet therapy (encorafenib, Erbitux and binimetinib), doublet therapy (encorafenib and Erbitux) or the control arm (irinotecan-based therapy and Erbitux). The primary endpoint of the trial is OS of the triplet therapy compared to the control arm. Secondary endpoints address efficacy of the doublet therapy compared to the control arm, and the triplet therapy compared to the doublet therapy. Other secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response, safety and tolerability. Health related quality of life data will also be assessed.

Array is conducting BEACON CRC in partnership with Pierre Fabre and Merck KGaA, Darmstadt, Germany at over 250 investigational sites in North America, South America, Europe and the Asia Pacific region. Patient enrollment is expected to be completed in 2018.

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