Array BioPharma today reported results for its first quarter of fiscal 2018 and provided an update on the progress of its key clinical development programs.
- Binimetinib and encorafenib New Drug Applications (NDAs) in BRAF-mutant melanoma accepted for review by U.S. Food and Drug Administration (FDA) and Marketing Authorization Applications (MAAs) validated for review by European Medicines Agency (EMA) -
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BOULDER, Colo., Oct. 31, 2017 /PRNewswire/ -- Array BioPharma, Inc. (Nasdaq: ARRY), a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule cancer therapies, today reported results for its first quarter of fiscal 2018 and provided an update on the progress of its key clinical development programs. COLUMBUS PHASE 3 TRIAL: Binimetinib and encorafenib submissions under review at FDA and EMA "We look forward to supporting the FDA and EMA reviews of the submissions for binimetinib and encorafenib," said Ron Squarer, Chief Executive Officer. "The robust progression free survival benefit together with the attractive tolerability profile demonstrated in COLUMBUS suggest the combination represents a potentially important addition to the MEK/BRAF treatment landscape for patients with BRAF-mutant melanoma. We continue to build our team to support potential commercialization in 2018." Metastatic melanoma is the most serious and life-threatening type of skin cancer and is associated with low survival rates[1-2]. There are about 200,000 new cases of melanoma diagnosed worldwide each year, approximately half of which have BRAF mutations, a key target in the treatment of metastatic melanoma[1, 3, 4]. Binimetinib and encorafenib are investigational medicines and are not currently approved in any country. BEACON CRC PHASE 3 TRIAL: Promising results from safety lead-in presented at 2017 ESMO At the 2017 ESMO Congress held during the quarter, safety results and initial clinical activity were presented from the safety lead-in of the Phase 3 BEACON CRC study evaluating the triplet combination of binimetinib, encorafenib and Erbitux® (BINI 45 mg twice daily, ENCO 300 mg daily and CETUX per label). As of the data cutoff date of August 9, 2017, 30 patients were treated in the safety lead-in and received the triplet combination. Out of the 30 patients, 29 had a BRAFV600E mutation. Microsatellite instability-high (MSI-H) was detected in only one patient. The triplet demonstrated good tolerability, supporting initiation of the randomized portion of the study. In addition, promising initial clinical activity was observed, with a confirmed overall response rate (ORR) of 41%, including a complete response, in patients with the BRAFV600E mutation, a group of patients with historically poor outcomes. Responses were observed in 10 out of 17 patients (59%) who had received only one prior line of therapy. Out of 28 patients with both a BRAFV600E mutation and a post-baseline assessment, 27 showed tumor regression. In the safety lead-in, the triplet combination was generally well-tolerated. The most common grade 3 or 4 AEs observed in at least 10% of patients were nausea (10%), vomiting (10%), increased blood creatine kinase (10%) and urinary tract infection (10%). Three patients discontinued treatment due to AEs with only one considered related to treatment. At the time of the analysis, 76% of patients remain on study treatment after a median duration of treatment of 5.6 months (range 1.0 - 9.3 months). "The BRAF mutation carries a very poor prognosis for patients with advanced colorectal cancer, and is particularly unresponsive after first-line therapy," said Dr. Victor Sandor, Chief Medical Officer. "In the safety lead-in, the triplet combination was well tolerated and showed impressive results with a confirmed overall response rate of 41%. Several patients also showed prolonged stable disease, with 76% of patients overall continuing on therapy after a median duration of exposure of 5.6 months. These results are unprecedented for this patient population based on existing standards of care." BEACON CRC was initiated based on results from a Phase 2 study that included the combination of encorafenib and cetuximab in 50 patients with advanced BRAF-mutant CRC, and that was presented at the 2016 ASCO annual meeting. In this Phase 2 study, Overall Survival for patients treated with the doublet combination of encorafenib and cetuximab exceeded one year, which is more than double several separate historical standard of care published benchmarks for this population. [12-17] In addition, confirmed ORR from this study was 22%, whereas historical published benchmarks in this patient population using standard of care regimens range between 4-8%. [15-18] Worldwide, colorectal cancer is the third most common type of cancer in men and the second most common in women, with approximately 1.4 million new diagnoses in 2012. Of these, nearly 750,000 were diagnosed in men, and 614,000 in women. Globally in 2012, approximately 694,000 deaths were attributed to colorectal cancer. In the U.S. alone, an estimated 135,430 patients will be diagnosed with cancer of the colon or rectum in 2017, and approximately 50,000 are estimated to die of their disease. [5] In the United States, BRAF mutations are estimated to occur in 10 to 15 percent of patients with colorectal cancer and represent a poor prognosis for these patients.[6-9] Based on recent estimates, the prevalence of MSI-H in tumors from patients with metastatic BRAF-mutant CRC ranged from 14% in a Phase 1b/2 trial (NCT01719380) (Array, data on file) to 18% from a recent Southwestern Oncology Group (SWOG) randomized phase 2 study.[10] NEW CLINICAL TRIAL INITIATED IN MICROSATELLITE STABLE METASTATIC CRC (MSS CRC) WITH BRISTOL-MYERS SQUIBB; TRIAL WITH MERCK EXPECTED TO BEGIN IN SECOND HALF OF 2017 The clinical trial in collaboration with Bristol-Myers Squibb, which was initiated in September 2017, will investigate the safety, tolerability and efficacy of binimetinib in combination with Bristol-Myers Squibb's Opdivo® (nivolumab) and Opdivo + Yervoy® (ipilimumab) regimen in patients with advanced MSS CRC and presence of a RAS mutation who have received one or two prior lines of therapy. The trial in collaboration with Merck, which is expected to begin during the second half of 2017, will investigate the safety, tolerability and efficacy of binimetinib with Merck's KEYTRUDA® (pembrolizumab) as part of multiple novel regimens. Array entered into these collaborations based on the growing body of preclinical and clinical evidence that the immune activity of an anti-PD-1 therapy can be enhanced when combined with a MEK inhibitor, such as binimetinib. The Phase 1/2 studies are expected to establish recommended dose regimens and explore the preliminary anti-tumor activity of the combinations. Results from these studies will be used to determine optimal approaches to further clinical development of these combinations. Under the Merck agreement, Merck will act as the sponsor of this clinical trial, and Array will supply Merck with binimetinib for use in the trial. Under the Bristol-Myers Squibb agreement, Array and Bristol-Myers Squibb will jointly support the study with Array acting as the sponsor. OTHER CLINICAL UPDATES: ARRY-382 and ARRY-797 programs Array plans to initiate a Phase 3 trial of ARRY-797, an oral, selective p38 MAPK inhibitor, in patients with LMNA A/C-related dilated cardiomyopathy as it evaluates options regarding the asset, including advancing it internally, partnering the program or creating a separate company to advance development and commercialization. LMNA A/C-related dilated cardiomyopathy is a rare, degenerative cardiovascular disease caused by mutations in the LMNA gene and characterized by poor prognosis. FINANCIAL HIGHLIGHTS Raised $258.8 million in public offering First Quarter of Fiscal 2018 Compared to Fourth Quarter of Fiscal 2017 (Sequential Quarters Comparison)
First Quarter of Fiscal 2018 Compared to First Quarter of Fiscal 2017 (Prior Year Comparison)
CONFERENCE CALL INFORMATION
Date: Tuesday, October 31, 2017
Time: 9:00 a.m. Eastern Time
Toll-Free: (844) 464-3927
Toll: (765) 507-2598
Pass Code: 94698561
Webcast, including Replay and Conference Call Slides: About Array BioPharma References Forward-Looking Statement -more-
Array BioPharma Inc.
Condensed Statements of Operations
(Unaudited)
(in thousands, except per share amounts)
Three Months Ended
September 30,
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2017 2016
---- ----
Revenue
Reimbursement
revenue $18,192 $31,321
Collaboration and
other revenue 8,008 6,289
License and
milestone revenue 3,546 1,661
Total revenue 29,746 39,271
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Operating expenses
Cost of partnered
programs 11,759 8,845
Research and
development for
proprietary
programs 41,445 46,563
General and
administrative 12,048 7,862
Total operating
expenses 65,252 63,270
------ ------
Loss from operations (35,506) (23,999)
Other income (expense)
Impairment loss
related to cost
method investment - (1,500)
Realized gains on
investments and
other - -
Change in fair value
of notes payable 200 (200)
Interest income 525 70
Interest expense (3,213) (2,979)
Total other
expense, net (2,488) (4,609)
------ ------
Net loss $(37,994) $(28,608)
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Net loss per share - basic $(0.22) $(0.20)
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Net loss per share - diluted $(0.22) $(0.20)
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Weighted average shares outstanding - basic 174,772 145,100
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Weighted average shares outstanding - diluted 174,772 145,100
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Summary Balance Sheet Data
(Unaudited)
(in thousands)
September 30, 2017 June 30, 2017
------------------ -------------
Cash, cash equivalents and
marketable securities $464,336 $235,055
Working capital $402,899 $200,626
Total assets $502,309 $279,145
Long-term debt, net $123,266 $121,305
Total stockholders' equity $226,621 $11,727
CONTACT: Tricia Haugeto
(303) 386-1193
thaugeto@arraybiopharma.com
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Company Codes: NASDAQ-NMS:ARRY |
