First targeted therapy to show activity in patients with NRAS mutated
BOULDER, Colo.--(BUSINESS WIRE)--Jun. 4, 2012--
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.
“Significant treatment progress has been achieved for patients with
advanced melanoma, particularly those with BRAF mutations, over the past
few years,” said Paolo A. Ascierto, MD, Director of the Unit of Medical
Oncology and Innovative Therapy, National Tumor Institute Fondazione G.
Pascale. “However, for patients with NRAS mutations, no targeted
treatment has been available and prognosis is poor. MEK162 has shown for
the first time efficacy in the NRAS mutated melanoma population. This is
another important brick in the wall we are building to stop melanoma.”
In conclusion, MEK162, the first targeted therapy to show activity in
patients with NRAS mutant melanoma, showed clinical activity and good
tolerability in patients with BRAF and NRAS mutated advanced melanoma.
Novartis is evaluating the development options of MEK162 in melanoma.
About Metastatic Melanoma and BRAF / NRAS Mutations
When melanoma is diagnosed early, it is generally a curable disease.
However, when it spreads to other parts of the body, it is the deadliest
and most aggressive form of skin cancer. A person with metastatic
melanoma typically has on average a short life expectancy that is
measured in months. The American Cancer Society estimates there will be
more than 76,000 new cases of melanoma and over 9,000 melanoma deaths in
the United States in 2012. BRAF and NRAS mutations occur in 50 to 60
percent and 15 to 20 percent of patients with melanoma, respectively.
About MEK and MEK162
MEK is a key protein kinase in the RAS/RAF/MEK/ERK pathway, which
signals cancer cell proliferation and survival. MEK has been shown to be
frequently activated in cancer, in particular in tumors that have
mutations, including BRAF and NRAS, in the RAS and RAF pathways. MEK162
is a small molecule MEK inhibitor that targets a key position in this
pathway and is in Phase 2 development in a range of tumors.
MEK162 was identified by Novartis as reaching clinical proof of concept
in November 2011. Novartis is planning or currently recruiting patients
for nine clinical trials, including two Phase 2 trials, three Phase 1b
trials in combination with different PI3 kinase inhibitors and two Phase
1b trials in combination with different RAF inhibitors.
About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the
discovery, development and commercialization of targeted small-molecule
drugs to treat patients afflicted with cancer and inflammatory diseases.
Our proprietary drug development pipeline includes clinical candidates
that are designed to regulate therapeutically important target proteins
and are aimed at significant unmet medical needs. For more information
on Array, please go to www.arraybiopharma.com.
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements about the timing of completion or initiation of
further trials involving MEK162, the potential for the results of
ongoing clinical trials to support regulatory approval or the marketing
success of MEK162, and future plans to progress and develop MEK162.
These statements involve significant risks and uncertainties, including
those discussed in the most recent annual report filed on form 10-K,
quarterly reports filed on Form 10-Q, and other reports filed by Array
with the Securities and Exchange Commission. Because these statements
reflect current expectations concerning future events, actual results
could differ materially from those anticipated in these forward-looking
statements as a result of many factors. These factors include, but are
not limited to, the ability of Novartis to continue to fund and
successfully progress research and development efforts with respect to
MEK162; risks associated with dependence on collaborators for the
clinical development and commercialization of out-licensed drug
candidates, including MEK162; the ability to effectively and timely
conduct clinical trials in light of increasing costs and difficulties in
locating appropriate trial sites and in enrolling patients who meet the
criteria for certain clinical trials; and risks associated with
dependence on third-party service providers to successfully conduct
clinical trials within and outside the United States. Array is providing
this information as of June 4, 2012 and undertakes no duty to update any
forward-looking statements to reflect the occurrence of events or
circumstances after the date of such statements or of anticipated or
unanticipated events that alter any assumptions underlying such
Source: Array BioPharma Inc.
Array BioPharma Inc.
Tricia Haugeto, 303-386-1193