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Ron Squarer, Chief Executive Officer, gave guidance for data from the phase-III trial of Binimetinib for NNRAS mutant melanoma. He stated, "It is exciting that Novartis is projecting the first regulatory filing for Binimetinib during the first half of 2016 for NRAS melanoma. So that would suggest the readout from the phase-III NEMO trial this year."
Source: Q2 FY 2015 earnings conference call, 2/03/15.

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Array To Regain Worldwide Rights To Binimetinib

- Array to receive up to $85 million upfront payment from Novartis -
- Novartis to conduct and/or substantially fund all ongoing and several planned clinical studies, including COLUMBUS, NEMO and MILO -
- Agreement subject to Novartis-GSK transaction close -
- Conference call to discuss transaction on Thursday, December 4, 2014 at 9:00 a.m. Eastern Time -

BOULDER, Colo., Dec. 3, 2014 /PRNewswire/ -- Array BioPharma Inc. (NASDAQ: ARRY) today announced that it has reached a definitive agreement with Novartis International Pharmaceutical Ltd. to regain full worldwide rights to binimetinib, a MEK inhibitor in three Phase 3 trials. This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline PLC (GSK) on April 22, 2014, which are expected in the first half of 2015, and remain subject to regulatory approval. Array had previously granted Novartis worldwide exclusive rights to develop and commercialize binimetinib under a 2010 License Agreement, which will terminate and be superseded by a new set of agreements between the parties.

"Regaining full worldwide rights to binimetinib, an innovative late-stage oncology product, represents a tremendous opportunity for Array," said Ron Squarer, Chief Executive Officer, Array BioPharma. "Binimetinib is currently advancing in three Phase 3 clinical trials and, we expect to file for our first regulatory approval during the first half of 2016. With this agreement, we are in a strong position to successfully develop and commercialize binimetinib to the benefit of cancer patients."

Novartis stated, "Binimetinib has demonstrated promising results for cancer patients across several different clinical trials. We are committed to supporting a successful transition to Array."

Terms of the Agreement Upon deal close, Array will receive up to $85 million and Novartis' global, exclusive license to binimetinib will terminate with all rights reverting to Array. Novartis has agreed to provide transitional regulatory, clinical development and manufacturing services as specified below and will assign to Array patent and other intellectual property rights it owns to the extent relating to binimetinib. All clinical trials involving binimetinib, including the COLUMBUS, NEMO and MILO pivotal trials, will continue to be conducted as currently contemplated.
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Source: press release, 12/03/14. http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-newsArt...

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Ron Squarer, Chief Executive Officer, gave guidance for data from the phase-III trial of MEK-162 for NRAS-mutant melanoma. He stated, "There are currently three phase-III trials enrolling with MEK-162 in advanced cancer patients; those are NRAS-mutant melanoma, low-grade serous ovarian cancer and BRAF-mutant melanoma, which I just described. The NRAS-mutant melanoma will likely be the first indication for MEK-162 as top-line results from this registration trial are expected in October of next year, so just about same time next year."
Source: Q1 FY 2014 earnings conference call, 10/31/13.

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Array initiated its first Phase 3 trial with MEK162 in patients with low-grade serous ovarian cancer (LGSOC), and Novartis, who is co-developing MEK162 with Array, initiated a Phase 3 trial with MEK162 in patients with NRAS melanoma. Novartis announced plans to begin a Phase 3 trial in patients with BRAF-mutant melanoma later this year.
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Source: press release, 8/07/13. http://phx.corporate-ir.net/phoenix.zhtml?c=123810&p=irol-newsArticle&ID...

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NEMO - A Randomized Phase III, Open Label, Multicenter, Two-arm Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Patients With Advanced Unresectable or Metastatic NRAS Mutation-positive Melanoma
Estimated Enrollment: 393
Study Start Date: July 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01763164?term=MEK162&phase=2&rank=...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Binimetinib / EncorafenibOncologyMelanomaMEK and Raf protein kinase inhibitorMEK and Raf protein kinase

Mechanism of action: Binimetinib (ARRY-162), a SM-inhibitor, interferes with cancer cell proliferation by disruption of the Ras/Raf/MEK/ERK cell proliferation and survival pathway via small molecule inhibition of the MEK protein kinase. Encorafenib (LGX818) is an orally available Raf kinase inhibitor with potential antineoplastic activity. LGX818 specifically inhibits Raf kinase, a serine/threonine enzyme in the RAF/mitogen-activated protein kinase kinase (MEK)/extracellular signal-related kinase (ERK) signaling pathway. By inhibiting the activation of the RAF/MEK/ERK signaling pathway, the administration of LGX818 may result in a decrease in proliferation of tumor cells. The Raf mutation BRAF V600E is frequently upregulated in a variety of human tumors and results in the constitutive activation of the RAF/MEK/ERK signaling pathway that regulates cellular proliferation and survival.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2015-10-01 - 2015-12-31

Results:

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Array Presents Full Results from Phase 3 NEMO Study
Binimetinib meets primary PFS endpoint in high unmet need patient population
Abstract No. 9500
BOULDER, Colo., June 6, 2016 /PRNewswire/ -- Array BioPharma (Nasdaq: ARRY) announced full results at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract No. 9500) from the pivotal Phase 3 NEMO (NRAS MELANOMA AND MEK INHBITOR) trial of binimetinib. The study found binimetinib significantly extended median progression-free survival (PFS), the study's primary endpoint, at 2.8 months, as compared with 1.5 months observed with dacarbazine [hazard ratio (HR)=0.62 (95% CI 0.47-0.80), p<0.001] – the first trial to ever meet a PFS endpoint in patients with advanced NRAS-mutant melanoma. In the pre-specified subset of patients who received prior treatment with immunotherapy, including ipilimumab, nivolumab or pembrolizumab, patients who received binimetinib experienced 5.5 months of median PFS (95% CI, 2.8–7.6), compared with 1.6 months for those receiving treatment with dacarbazine (95% CI, 1.5–2.8).

Array BioPharma. (PRNewsFoto/Array BioPharma Inc.)
"The NEMO findings are promising and suggest binimetinib may provide a new treatment option for the thousands of patients who are diagnosed with NRAS-mutant melanoma," said lead study investigator Reinhard Dummer, M.D., Professor, Dept. of Dermatology, University of Zurich Hospital. "Particularly compelling are the results in the pre-specified sub-group of patients who had received prior treatment with immunotherapy, which is now recognized as the standard of care for first-line treatment in this patient population."

In addition to improving PFS, binimetinib also demonstrated significant improvement in overall response rate (ORR) and disease control rate (DCR). While there was no statistically significant difference demonstrated in overall survival, the median overall survival (mOS) favored the binimetinib arm.

Confirmed ORR was 15 percent (95% CI, 11-20 percent) in patients receiving binimetinib vs. 7 percent (95% CI, 3-13 percent) in patients receiving dacarbazine.
DCR for patients receiving binimetinib was 58 percent (95% CI, 52-64 percent) vs. 25 percent (95% CI, 18-33 percent) for patients receiving dacarbazine.
mOS was estimated at 11.0 months in patients receiving binimetinib vs. 10.1 months for patients treated with dacarbazine [(HR) = 1.0 (95% CI 0.75-1.33), p=0.499].
"NRAS-mutant melanoma impacts one out of five advanced melanoma patients, yet there are currently no treatment options indicated specifically for these patients," said study investigator Keith T. Flaherty, M.D., Director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital and Professor of Medicine, Harvard Medical School. "There remains a need for additional effective treatments for patients with NRAS–mutant disease. Binimetinib may provide another important treatment option for this patient population."

Binimetinib was generally well-tolerated and the adverse events (AEs) reported were consistent with previous results in NRAS-mutant melanoma patients. Grade 3/4 AEs reported in greater than or equal to 5 percent of patients receiving binimetinib included increased creatine phosphokinase (CPK) and hypertension.

"The NEMO trial results demonstrate the potential of binimetinib to help slow disease progression in this patient population, an often overlooked subset without treatment options beyond immunotherapy," explained Victor Sandor, M.D., Chief Medical Officer, Array BioPharma. "Based on the strength of these data, we plan to submit our regulatory filing for binimetinib in NRAS-mutant melanoma later this month."
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Source: press release, 6/06/16. http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-newsArt...

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Array BioPharma Announces Phase 3 Binimetinib Trial Meets Primary Endpoint For NRAS-Mutant Melanoma
-- Binimetinib achieves statistically significant progression free survival compared to chemotherapy --
-- Regulatory submissions planned for the first half of 2016 --
BOULDER, Colo., Dec. 16, 2015 /PRNewswire/ -- Array BioPharma (Nasdaq: ARRY) today reported top-line results from the ongoing Phase 3 clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma, known as the NEMO trial. The study met its primary endpoint of improving progression-free survival (PFS) compared with dacarbazine treatment. The median PFS on the binimetinib arm was 2.8 months versus 1.5 months on the dacarbazine arm; hazard ratio (HR) 0.62, [95% CI 0.47-0.80], p < 0.001.

Array BioPharma.
In the trial, binimetinib was generally well-tolerated and the adverse events reported were consistent with previous results in NRAS melanoma patients.

Array plans to submit binimetinib to regulatory authorities for marketing approval in NRAS-mutant melanoma during the first half of 2016. Results from the NEMO trial including progression free survival, overall survival, objective response rate, safety and prespecified subgroup analyses including outcomes in patients who received prior treatment with immunotherapy will be presented at a medical meeting in 2016.

"We are excited to announce positive results from the NEMO trial, which suggest binimetinib has the potential to provide an important new treatment option for patients with advanced NRAS melanoma," said Ron Squarer, Chief Executive Officer, Array BioPharma. "We look forward to discussing the data with the FDA and other regulatory agencies in the near future."

"The presence of an NRAS mutation is a poor prognostic indicator for patients with advanced melanoma," said Keith T. Flaherty, M.D., Associate Professor, Medicine, Harvard Medical School and Director of Developmental Therapeutics, Cancer Center, Massachusetts General Hospital. "I am encouraged the NEMO trial met its primary endpoint and look forward to sharing the full results soon. As the first targeted therapy with positive results in NRAS melanoma, binimetinib will be a welcome addition in this high unmet need population, especially for patients whose disease has progressed following treatment with immunotherapy."

Binimetinib is also being studied in the Phase 3 COLUMBUS trial for patients with BRAF-mutant melanoma and the Phase 3 MILO trial for patients with low grade serous ovarian cancer, as well as in several other earlier stage clinical trials.
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Source: press release, 12/16/15. http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-newsArt...

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