BOULDER, Colo., Dec. 19, 2017 /PRNewswire/ -- Array
BioPharma (Nasdaq: ARRY) announced today that it has entered into a
clinical trial collaboration agreement with Pfizer to investigate
the safety and efficacy of several novel anti-cancer combinations,
including Array's MEK inhibitor, binimetinib, with Pfizer's
investigational PARP inhibitor talazoparib, and avelumab*, a human
anti-PD-L1 IgG1 monoclonal antibody.
The companies are entering into this collaboration to explore
the potential benefits of combining molecularly targeted
therapeutics with the body's innate cancer-fighting abilities using
immunotherapy.
"Array is excited to announce this partnership with Pfizer, an
established global leader in Oncology therapeutics," said Ron
Squarer, Chief Executive Officer, Array BioPharma. "These novel
approaches combining targeted therapy and immunotherapy hold great
potential to help patients fighting cancer in different
indications, with an initial main focus on lung and pancreatic
cancer."
"Preclinical data indicate that combining binimetinib with an
immune checkpoint inhibitor and talazoparib could be a rational
combination to test in the clinic," said Chris Boshoff, M.D., Ph.D., Senior Vice
President and Head of Immuno-Oncology, Early Development and
Translational Oncology, Pfizer Global Product Development.
"We are looking forward to initiating the clinical studies with
Array BioPharma to explore anti-tumor activity across various novel
combination strategies, including both doublet and triplet
approaches."
Under the terms of the agreement, Array and Pfizer will
collaborate on a Phase 1b clinical
trial to explore a series of novel combinations, investigating the
safety and efficacy of the combination of binimetinib, avelumab and
talazoparib across various tumor types. A multi-arm clinical trial
is expected to establish recommended doses of different regimens
combining the drugs. Initially the focus will be in non-small cell
lung cancer (NSCLC) and pancreatic cancer, and additional
indications will be explored at a later stage. The study is
expected to begin by the third quarter of 2018, and results will be
used to determine optimal approaches to further clinical
development of these combinations.
Under the collaboration agreement, the trial will be sponsored
and funded by Pfizer, with Array providing binimetinib
supply.
*Avelumab is jointly developed by Merck KGaA, Darmstadt,
Germany and Pfizer. Avelumab is
under clinical investigation for treatment of NSCLC and pancreatic
cancer and has not been demonstrated to be safe and effective for
these indications. There is no guarantee that avelumab will be
approved for these indications by any health authority
worldwide.
About Binimetinib
MEK is a key protein kinase in the
MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this
pathway regulates several key cellular activities including
proliferation, differentiation, survival and angiogenesis.
Inappropriate activation of proteins in this pathway has been shown
to occur in many cancers, such as melanoma, colorectal and thyroid
cancers. Binimetinib is a late-stage, small molecule MEK inhibitor
which targets key enzymes in this pathway. Binimetinib is an
investigational medicine and is not currently approved in any
country.
Binimetinib is being studied in clinical trials in advanced
cancer patients, including the Phase 3 COLUMBUS trial in patients
with BRAF-mutant melanoma and the Phase 3 BEACON CRC trial in
patients with BRAF V600E-mutant colorectal cancer.
About Avelumab
Avelumab is a human anti-programmed
death ligand-1 (PD-L1) antibody. Avelumab has been shown in
preclinical models to engage both the adaptive and innate immune
functions. By blocking the interaction of PD-L1 with PD-1
receptors, avelumab has been shown to release the suppression of
the T cell-mediated antitumor immune response in preclinical
models. Avelumab has also been shown to induce NK cell-mediated
direct tumor cell lysis via antibody-dependent cell-mediated
cytotoxicity (ADCC) in vitro. In November
2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic
alliance to co-develop and co-commercialize avelumab.
Avelumab is currently being evaluated in the JAVELIN clinical
development program, which involves at least 30 clinical programs,
including nine Phase III trials, and more than 7,000 patients
across more than 15 different tumor types, including
gastric/gastroesophageal junction, non-small cell lung cancer,
renal cell carcinoma and ovarian cancer. For a comprehensive list
of all avelumab trials, please visit clinicaltrials.gov.
Indications in the US
The FDA granted accelerated
approval for avelumab (BAVENCIO®) for the treatment of
(i) adults and pediatric patients 12 years and older with
metastatic Merkel cell carcinoma (MCC) and (ii) patients with
locally advanced or metastatic urothelial carcinoma (UC) who have
disease progression during or following platinum-containing
chemotherapy, or have disease progression within 12 months of
neoadjuvant or adjuvant treatment with platinum-containing
chemotherapy. These indications are approved under accelerated
approval based on tumor response rate and duration of response.
Continued approval for these indications may be contingent upon
verification and description of clinical benefit in confirmatory
trials.
Important Safety Information from the US FDA Approved
Label
The warnings and precautions for BAVENCIO include
immune-mediated adverse reactions (such as pneumonitis, hepatitis,
colitis, endocrinopathies, nephritis and renal dysfunction and
other adverse reactions), infusion-related reactions and
embryo-fetal toxicity.
Common adverse reactions (reported in at least 20% of patients)
in patients treated with BAVENCIO for mMCC and patients with
locally advanced or metastatic UC include fatigue, musculoskeletal
pain, diarrhea, nausea, infusion-related reaction, peripheral
edema, decreased appetite/hypophagia, urinary tract infection and
rash.
For full prescribing information and medication guide for
BAVENCIO, please see www.BAVENCIO.com.
About Talazoparib
Talazoparib is an investigational
anti-cancer compound called a PARP (poly ADP ribose polymerase)
inhibitor. Preclinical studies suggest that talazoparib is highly
potent and has a dual mechanism of action, with the potential to
induce tumor cell death by blocking PARP enzyme activity and
trapping PARP on the sites of DNA damage. Talazoparib is currently
being evaluated in advanced germline (inherited) BRCA+ breast
cancer as well as other cancer types with deficiencies in DNA
damage repair (DDR). Talazoparib has not been approved by any
regulatory authorities for the treatment of any disease.
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. Nine registration studies are
currently advancing related to seven Array-owned or partnered
drugs: binimetinib (MEK162), encorafenib (LGX818), selumetinib
(partnered with AstraZeneca), danoprevir (partnered with Roche),
ipatasertib (partnered with Genentech), larotrectinib (partnered
with Loxo Oncology) and tucatinib (partnered with Cascadian
Therapeutics).
Array BioPharma Forward-Looking Statement
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 the commencement of the binimetinib,
BAVENCIO and talazoparib clinical trial; expectations that
events will occur relating to this collaboration that will result
in greater value for Array; and the potential for the results of
the planned clinical trial to support regulatory approval or the
marketing success of the combination. These statements involve
significant risks and uncertainties, including those discussed in
our most recent annual report filed on Form 10-K, in our quarterly
reports filed on Form 10-Q, and in other reports filed by Array
with the Securities and Exchange Commission. Because these
statements reflect our current expectations concerning future
events, our 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
determination by the FDA that results from planned clinical trial
are not sufficient to support registration or marketing approval of
binimetinib and encorafenib; Pfizer's 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 a dependence on third-party service providers
to successfully conduct clinical trials within and outside
the United States. We are
providing this information as of December
19, 2017. We undertake 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
statements.
CONTACTS:
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Tricia
Haugeto
|
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(303)
386-1193
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thaugeto@arraybiopharma.com
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SOURCE Array BioPharma Inc.