CHICAGO and SAN FRANCISCO, June 5,
2017 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR)
today announced that it presented new findings from two Phase 1
clinical studies of NKTR-214, Nektar's lead immuno-oncology
candidate, a CD122-biased agonist, at the 2017 American Society of
Clinical Oncology (ASCO) Annual Meeting.
NKTR-214 is an investigational immuno-stimulatory therapy
designed to expand specific cancer-fighting CD8+ effector T cells
and natural killer (NK) cells directly in the tumor
micro-environment and increase expression of PD-1 on these immune
cells.
"We are very excited about the initial data emerging from the
PIVOT study evaluating NKTR-214 in combination with nivolumab,"
said Mary Tagliaferri, M.D., Senior
Vice President of Clinical Development at Nektar Therapeutics.
"The combination is showing early clinical benefit in
patients with both melanoma and renal cell carcinoma. We've
observed RECIST responses in 3 of 4 patients with BRAF-positive
Stage IV melanoma in the study, including a durable complete
response that occurred at week 6 on treatment. These patients
had very poor prognosis coming into the study, including high
baseline LDH levels and liver metastases. In addition, the
combination treatment has a favorable safety profile and we have
not observed any grade 3 or higher treatment-related AEs
to-date. We look forward to identifying a Phase 2 dose and
initiating the expansion cohorts for the PIVOT trial in our 8
target indications in the third quarter of 2017."
New findings were presented in patients from an ongoing Phase 1
dose-escalation study evaluating monotherapy NKTR-214 in patients
with solid tumors in a poster session at the 2017 American
Society of Clinical Oncology Annual Meeting
in Chicago:
- Confirmed partial responses (PRs) were observed in 3 of 4
patients with Stage IV renal cell carcinoma (RCC) who were
immuno-oncology (I-O) treatment naïve who experienced stable
disease (SD) with tumor shrinkage while on NKTR-214 monotherapy
(range of 3-8 cycles) and then received sequential therapy with
nivolumab. All three patients with confirmed PRs experienced
rapid responses at first 8-week scan after initiating sequential
therapy with nivolumab. The fourth patient experienced SD at first
8-week scan. All four patients had progressed on one or more
prior tyrosine-kinase inhibitor (TKI) therapies and all are
continuing on therapy with nivolumab.
- Two heavily pre-treated Stage IV patients are continuing
treatment with monotherapy NKTR-214. One patient with
BRAF-mutated melanoma, who was previously treated with ipilimumab
and vemurafenib, continues on NKTR-214 therapy with SD for greater
than 15 months. One patient with RCC who was previously
treated with high-dose IL-2 and subsequently refractory to single
agent treatments with OX40 and nivolumab, continues on NKTR-214
therapy with SD for greater than 10 months.
- NKTR-214 monotherapy demonstrated a favorable safety profile
with no immune-related adverse events (AEs) (N=28, Stage IV
patients)
- Data from blood and tumor samples show that NKTR-214 increases
immune cells in the blood and tumor microenvironment even in
subjects who have failed multiple prior immunotherapeutic
agents.
Initial data were presented from the ongoing PIVOT
dose-escalation trial evaluating NKTR-214 in combination with
nivolumab in patients with melanoma, renal cell carcinoma and
non-small cell lung cancer. As of June
1, 2017, 20 patients were enrolled in the dose-escalation
phase of the ongoing PIVOT study in a number of dose cohorts.
Findings from the first patients enrolled in the ongoing study are
as follows:
- Clinical benefit data (evaluable scans) were available for
initial patients enrolled in the trial:
-
- Responses (RECIST 1.1) were observed in 3 of 4 patients with
BRAF-mutated Stage IV melanoma (1 CR, 2 uPR). Time to
response for these patients, respectively, was 6 weeks, 7 weeks and
20 weeks. All three patients with responses are ongoing
treatment in the trial.
- Two patients with RCC who were I-O naïve were evaluable for at
least two scans. A confirmed PR (-39%) was observed in one of
these patients (PD-L1 negative) who progressed on prior TKI
therapy. Time to response was 15 weeks. The second
patient, who progressed on prior bevacizumab therapy, experienced
SD and is continuing on treatment.
- 4 additional RCC IO naïve patients were evaluable for one
scan. All four had SD in their target lesions and are
continuing on treatment in the study.
- On treatment tumor biopsies from the PIVOT trial show robust
expansion of ICOS+ CD4 and CD8 T cells with the combination of
NKTR-214 and nivolumab.
- All dose cohorts of NKTR-214 and nivolumab demonstrate a
favorable safety profile and are well-tolerated. In the study
to-date, there are no dose-limiting toxicities, no grade 3 or
higher treatment-related AEs, and no immune-related AEs (such as
colitis, dermatitis, pneumonitis or endocrinopathies).
- The dose-escalation portion of the trial is enrolling with the
last dose cohort recently initiated (NKTR-214 0.009 mg/kg q3w +
nivo 360 mg q3w) in order to identify a recommended Phase 2
dose.
NKTR-214 preferentially binds to the CD122 receptor on the
surface of cancer-fighting immune cells in order to stimulate their
proliferation. In clinical and preclinical studies, treatment with
NKTR-214 resulted in 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.
About Nektar
Nektar Therapeutics is a research-based
biopharmaceutical company whose mission is to discover and develop
innovative medicines to address the unmet medical needs of
patients. Our R&D pipeline of new investigational medicines
includes treatments for cancer, auto-immune disease and chronic
pain. We leverage Nektar's proprietary and proven chemistry
platform in the discovery and design of our new therapeutic
candidates. Nektar is headquartered in San Francisco, California, with additional
operations in Huntsville, Alabama
and Hyderabad, India. Further
information about the company and its drug development programs and
capabilities may be found online at http://www.nektar.com.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking
statements which can be identified by words such as: "anticipate,"
"intend," "plan," "expect," "believe," "should," "may," "will" and
similar references to future periods. Examples of forward-looking
statements include, among others, statements we make regarding the
therapeutic potential of NKTR-214, observations from early data
emerging from ongoing clinical trials of NKTR-214, the anticipated
timing of starting the expansion cohorts for the PIVOT study, and
the potential of our technology and drug candidates in our research
and development pipeline. Forward-looking statements are
neither historical facts nor assurances of future performance.
Instead, they are based only on our current beliefs, expectations
and assumptions regarding the future of our business, future plans
and strategies, anticipated events and trends, the economy and
other future conditions. Because forward-looking statements relate
to the future, they are subject to inherent uncertainties, risks
and changes in circumstances that are difficult to predict and many
of which are outside of our control. Our actual results may differ
materially from those indicated in the forward-looking statements.
Therefore, you should not rely on any of these forward-looking
statements. Important factors that could cause our actual results
to differ materially from those indicated in the forward-looking
statements include, among others: (i) our statements regarding the
therapeutic potential of NKTR-214 are based on findings and
observations from preclinical findings and ongoing clinical
studies; (ii) NKTR-214 is in early stage clinical development and
the risk of failure remains high and failure can unexpectedly occur
due to efficacy, safety or other unpredictable factors; (iii) the
initial preliminary RECIST response data reported in this press
release is subject to change—in particular, there is no way to
predict whether unconfirmed responses will become confirmed
responses as the clinical studies progress; (iv) the preliminary
clinical results from the NKTR-214 clinical studies described in
this press release remain subject to change as a result of final
data audit confirmation procedures to be conducted following
completion of the studies; (v) the timing of the commencement or
end of clinical studies and the availability of clinical data may
be delayed or unsuccessful due to regulatory delays, slower than
anticipated patient enrollment, manufacturing challenges, changing
standards of care, evolving regulatory requirements, clinical trial
design, clinical outcomes, competitive factors, or delay or failure
in ultimately obtaining regulatory approval in one or more
important markets; (vi) scientific discovery of new medical
breakthroughs is an inherently uncertain process and the future
success of applying our technology platform to potential new drug
candidates (such as NKTR-214) is therefore highly uncertain and
unpredictable and one or more research and development programs
could fail; (vii) patents may not issue from our patent
applications for our drug candidates including NKTR-214, patents
that have issued may not be enforceable, or additional intellectual
property licenses from third parties may be required; and (viii)
certain other important risks and uncertainties set forth in our
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on May 10, 2017. Any
forward-looking statement made by us in this press release is based
only on information currently available to us and speaks only as of
the date on which it is made. We undertake no obligation to update
any forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information,
future developments or otherwise.
Contact:
For Investors:
Jennifer Ruddock of Nektar
Therapeutics
415-482-5585
For Media:
Dan Budwick
1AB Media
973.271.6085
- Charych, D., et al., Clin Can
Res; 22(3) February 1,
2016
- Diab, A., et al., Journal for ImmunoTherapy of Cancer 2016,
4(Suppl 1):P369
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SOURCE Nektar Therapeutics