Full Press Release Details
Bristol-Myers Squibb and Nektar Therapeutics
Announce Oncology Clinical Collaboration to Evaluate the Combination of Opdivo (nivolumab) and NKTR-214
New collaboration will explore the potential
benefits of combining Bristol-Myers Squibb's anti-PD-1 antibody with Nektar's CD122-biased agonist in five tumor types
(SAN FRANCISCO and NEW YORK, September 27, 2016) - Bristol-Myers
Squibb Company (NYSE:BMY) and Nektar Therapeutics (Nasdaq: NKTR) today announced a new clinical collaboration to evaluate Bristol-Myers
Squibb's Opdivo (nivolumab) with Nektar's investigational medicine, NKTR-214, as a potential combination treatment
regimen in five tumor types and seven potential indications. Opdivo is a PD-1 immune checkpoint inhibitor designed to overcome
immune suppression. NKTR-214 is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting T cells
and natural killer (NK) cells directly in the tumor micro-environment and increase expression of PD-1 on these immune cells.
excited to explore the potential benefits in multiple types of cancer of the combination of Opdivo with Nektar's innovative
cancer immunotherapy," said Fouad Namouni, M.D., Head of Oncology Development, Bristol-Myers Squibb. "We believe that
a combination regimen which utilizes two different and complementary mechanisms designed to harness the body's own immune
system to fight cancer has the potential to provide new treatment options for patients."
The Phase 1/2 clinical trials will evaluate
the potential for the combination of Opdivo and NKTR-214 to show improved and sustained efficacy and tolerability above
the current standard of care in melanoma, kidney, colorectal, bladder and non-small cell lung cancer patients. An initial dose-escalation
trial is underway with Opdivo and NKTR-214.
Bristol-Myers Squibb and Nektar will equally
share costs of the combined therapy trials. Nektar will maintain its global commercial rights to NKTR-214.
very pleased to be collaborating with Bristol-Myers Squibb, a global leader in immuno-oncology, in order to advance quickly the
development of NKTR-214 with a PD-1 immune checkpoint inhibitor," said Howard W. Robin, President and CEO of Nektar Therapeutics.
"NKTR-214 is designed to grow tumor infiltrating lymphocytes (TILs) in vivo and replenish the immune system,
which is critically important as many patients battling cancer lack sufficient TIL populations to benefit from approved checkpoint
inhibitor therapies. The combination of checkpoint inhibition with T cell growth
could lead to synergistic effects that may provide a new treatment option for patients."
Opdivo was the first PD-1 immune
checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval
in 54 countries including the United States, Japan, and in the European Union.
NKTR-214 is an experimental therapy designed
to stimulate cancer-killing immune cells in the body by targeting CD122 specific receptors found on the surface of these immune
cells, known as CD8+ effector T cells and Natural Killer (NK) cells. In preclinical studies, treatment with NKTR-214 resulted in
a rapid expansion of these cells and mobilization into the tumor micro-environment.1,2 NKTR-214 has an antibody-like
dosing regimen similar to the existing checkpoint inhibitor class of approved medicines. A Phase 1/2 clinical study is ongoing
to evaluate single-agent NKTR-214 in cancer patients.
Bristol-Myers Squibb & Immuno-Oncology: Advancing
At Bristol-Myers Squibb, we have a vision for the future of
cancer care that is focused on Immuno-Oncology, now considered a major treatment choice alongside surgery, radiation, chemotherapy
and targeted therapies for certain types of cancer.
We have a comprehensive clinical portfolio of investigational
and approved Immuno-Oncology agents, many of which were discovered and developed by our scientists. Our ongoing Immuno-Oncology
clinical program is looking at broad patient populations, across multiple solid tumors and hematologic malignancies, and lines
of therapy and histologies, with the intent of powering our trials for overall survival and other important measures like durability
of response. We pioneered the research leading to the first regulatory approval for the combination of two Immuno-Oncology agents
and continue to study the role of combinations in cancer.
We are also investigating other immune system pathways in the
treatment of cancer including CTLA-4, CD-137, KIR, SLAMF7, PD-1, GITR, CSF1R, IDO and LAG-3. These pathways may lead to potential
new treatment options - in combination or monotherapy - to help patients fight different types of cancers.
Our collaboration with academia, as well as small and large
biotech and pharmaceutical companies, to research the potential of Immuno-Oncology and non-Immuno-Oncology combinations helps achieve
our goal of providing new treatment options in clinical practice.
At Bristol-Myers Squibb, we are committed to changing survival
expectations in hard-to-treat cancers and the way patients live with cancer.
Cancer cells may exploit "regulatory" pathways,
such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. Opdivo is a PD-1 immune
checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells, and blocks the binding of PD-L1
and PD-L2, preventing the PD-1 pathway's suppressive signaling on the immune system, including the interference with an anti-tumor
Opdivo's broad global development program is based
on Bristol-Myers Squibb's understanding of the biology behind Immuno-Oncology. Our company is at the forefront of researching
the potential of Immuno-Oncology to extend survival in hard-to-treat cancers. This scientific expertise serves as the basis for
the Opdivo development program, which includes a broad range of Phase 3 clinical trials evaluating overall survival as the
primary endpoint across a variety of tumor types. The Opdivo trials have also contributed toward the clinical and scientific
understanding of the role of biomarkers and how patients may benefit from Opdivo across the continuum of PD-L1 expression.
To date, the Opdivo clinical development program has enrolled more than 18,000 patients.
& IMPORTANT SAFETY INFORMATION
OPDIVO (nivolumab) as a single agent is indicated for the
treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
OPDIVO (nivolumab) as a single agent is indicated for the
treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated
approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description
of clinical benefit in confirmatory trials.
OPDIVO (nivolumab), in combination with YERVOY (ipilimumab),
is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated
approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description
of clinical benefit in the confirmatory trials.
OPDIVO (nivolumab) is indicated for the
treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations
prior to receiving OPDIVO.
OPDIVO (nivolumab) is indicated for the
treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO (nivolumab) is indicated for
the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic
stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin. This indication is approved under accelerated approval
based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical
benefit in confirmatory trials.
Please refer to the end of the Important Safety Information
for a brief description of the patient populations studied in the CheckMate trials.
IMPORTANT SAFETY INFORMATION
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
YERVOY can result in severe and fatal immune-mediated adverse
reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse
reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The
majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months
after discontinuation of YERVOY.
Assess patients for signs and symptoms of enterocolitis,
dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic
hormone (ACTH) level, and thyroid function tests at baseline and before each dose.
Permanently discontinue YERVOY and initiate systemic high-dose
corticosteroid therapy for severe immune-mediated reactions.