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Array Biopharma Reports Financial Results For The First Quarter Of Fiscal 2016

The following excerpt is from the company's SEC filing.

- Top-line results from binimetinib / NEMO Phase 3 trial expected by end of 2015 and first regulatory submission expected in first half of 2016 -

- Top-line results from binimetinib and encorafenib / COLUMBUS Phase 3 trial expected in first half of 2016 and regulatory submission expected in second half of 2016 -

- Positive data recently presented on binimetinib and encorafenib in BRAF- and NRAS-mutant melanoma -

BOULDER, Colo., Nov. 4, 2015 /PRNewswire/ -- Array BioPharma Inc. (NASDAQ: ARRY) today reported results for the first quarter of its fiscal year ending June 30, 2016 and provided an update on progress on its key clinical development programs.

Ron Squarer, Chief Executive Officer of Array, noted, "The first quarter has been a period of important progress as we continue to advance binimetinib and encorafenib, two innovative oncology products in Phase 3, toward 2016 regulatory submissions. Recently presented data supports the value of our BRAF-mutant melanoma and BRAF-mutant colorectal cancer programs by showing the potential for differentiation compared to other approaches."

KEY PIPELINE UPDATES

Binimetinib (MEK162) and encorafenib (LGX818)

NEMO (binimetinib / NRAS-mutant melanoma) and COLUMBUS Part 1 and Part 2 (binimetinib and encorafenib / BRAF-mutant melanoma) target enrollment achieved

NEMO and COLUMBUS top-line results expected in 2H 2015 and 1H 2016, respectively

BRAF- and NRAS-melanoma trial results presented at ESMO European Cancer Congress (ECC)

Update on Phase 3 trials

In April 2015, the NEMO Phase 3 study completed patient enrollment and Array expects top-line results by year end and a regulatory filing in the first half of 2016. In addition, the COLUMBUS (Part 1) study also completed enrollment in April 2015 and Array expects top-line results and reaffirms a projected regulatory filing of binimetinib and encorafenib in 2016. In October 2015, COLUMBUS (Part 2) achieved its target patient enrollment. The MILO Phase 3 trial in patients with low-grade serous ovarian cancer continues to enroll patients, and Array estimates the availability of top-line data from MILO, along with a projected regulatory filing, in 2017.

New BRAF-mutant melanoma interim results

LOGIC2 is an ongoing 140-patient, two-part study designed to explore the safety and activity of novel triplet combinations in BRAF-mutant melanoma. In Part 1, patients are treated with the combination of binimetinib and encorafenib until disease progression. Based on the results of molecular profiling at that time, each patient is assigned to one of four arms containing a triplet combination of binimetinib, encorafenib and a third innovative targeted therapy. Results from Part 1 of the study were reported separately for patients who have previously received a BRAF and/or MEK inhibitor versus those who were initially naïve to BRAF and MEK inhibitor treatment.

In Part 1, patients are treated with binimetinib 45 mg twice daily (BID) and encorafenib 450 mg once daily (QD), the same doses evaluated in the ongoing Phase 3 COLUMBUS trial. Interim results from this study were presented at ESMO ECC in September 2015. In the BRAF/MEK-naïve group (n=40), the interim overall response rate (confirmed and unconfirmed complete response or partial response) was 68%, with a 6-month progression-free survival estimate of 79%. Of note, 96% of patients in this group continued to receive study treatment as of the data cutoff. Preliminary data from all patients in the study (n=89) also indicate that the combination of binimetinib and encorafenib showed good tolerability with a 12% incidence of pyrexia and little to no rash or photosensitivity. These results indicate that the combination of binimetinib and encorafenib show encouraging clinical activity and an emerging differentiated tolerability profile relative to other MEK/BRAF inhibitor combinations.

New NRAS-mutant melanoma interim results

Promising preliminary antitumor activity from a Phase 1b/2 study of binimetinib in combination with ribociclib (Novartis, LEE011), a CDK4/6 inhibitor, in NRAS-mutant melanoma patients, was presented at ESMO ECC. Results were shared from 45 patients enrolled in the dose escalation portion of the study, which included two dosing schedules (28-day or 21-day cycles). For the 28-day dosing schedule, patients received continuous twice daily dosing of binimetinib while receiving ribociclib for 21 days per 28 day cycle. For the 21-day schedule, both agents were delivered for 14 days of a 21 day cycle.

For patients receiving the combination on a 28-day cycle (n=22), the Objective Response Rate (ORR, confirmed and unconfirmed complete or partial responses) was 41%, the Disease Control Rate (DCR, confirmed and unconfirmed complete or partial responses and stable disease) was 82% with a median Progression Free Survival (mPFS) of 6.7 months. Furthermore, the ORR was 56% (n=9) for patients receiving dose level 1 of the 28-day schedule consisting of binimetinib...


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