– NKTR-255 administered post completion of
concurrent chemoradiation and in combination with durvalumab
demonstrated statistically significant lymphocyte recovery compared
to historical controls at week 8 –
– Pharmacodynamic data show NKTR-255 increased
NK cell proliferation and markers of NK cell activation
–
SAN
FRANCISCO, Nov. 7, 2024 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) and collaborators at The University of Texas MD Anderson Cancer Center today
presented late-breaking results from a Phase 2 study evaluating
NKTR-255 for the treatment of radiation induced lymphopenia after
concurrent chemoradiation in locally advanced non-small cell lung
cancer (NSCLC) patients at the Society for Immunotherapy of Cancer
(SITC) 39th Annual Meeting.
NKTR-255 is a novel polymer-conjugated IL-15 agonist, designed
to activate, proliferate and expand natural killer (NK) and CD8+
T-cells, as well as to promote the survival and expansion of memory
CD8+ T cells. NKTR-255 is currently being evaluated in combination
with cellular therapies and immune checkpoint inhibitors. Previous
pre-clinical and clinical studies have shown that NKTR-255 can
proliferate a range of immune cells and augment lymphocyte
trafficking.1,2,3
The results from the preplanned interim analysis from the
REStoring lymphoCytes Using NKTR-255 after chemoradiothErapy in
solid tumors (RESCUE) trial suggest that NKTR-255 effectively
reversed radiation induced lymphopenia in patients with locally
advanced NSCLC receiving consolidation therapy with durvalumab.
Interim pharmacodynamic data demonstrated statistically significant
superiority of the eight-week absolute lymphocyte count (ALC) with
NKTR-255 post chemoradiation and in combination with durvalumab
versus non-contemporaneous control groups who received either
chemoradiation alone or chemoradiation in combination with
durvalumab.
"Radiation induced lymphopenia is common after chemoradiation
therapy and is associated with worse overall survival in multiple
solid tumors including lung cancer." said Steven H. Lin, MD, PhD, Professor of Radiation
Oncology at MD Anderson. "These interim results showing that
NKTR-255 can rapidly restore absolute lymphocyte counts post
chemoradiation suggest that NKTR-255 has the potential to confer
prognostic benefits and enhanced survival in patients with locally
advanced NSCLC."
"These results, combined with the body of evidence previously
reported with NKTR-255 in combination with cell therapy, highlight
NKTR-255's potential to enhance clinical benefit in both
hematologic malignancies and solid tumors" said Mary Tagliaferri, MD, Senior Vice President and
Chief Medical Officer at Nektar.
The Phase 2 single-arm study conducted by MD Anderson is
evaluating NKTR-255 (3µg/kg IV) following concurrent chemoradiation
and in combination with consolidation therapy with durvalumab.
NKTR-255 3µg/kg is administered intravenously every 4 weeks in
combination with durvalumab (1500mg IV) for up to 1 year
(NCT05632809). The primary objectives of the study are safety and
ALC normalization at Week 8 after initiation of NKTR-255 and
durvalumab post chemoradiation. Secondary endpoints include
progression-free survival and overall survival. The trial is
currently ongoing at MD Anderson.
Key details and takeaways from the presentation are as
follows:
Late-breaking Abstract (LBA) 1489: "
REStoring lymphoCytes Using NKTR-255 after chemoradiothErapy in
solid tumors (RESCUE): Preplanned Interim Safety and Efficacy
Analysis", Lin, S., et al.
- The combination of NKTR-255 and durvalumab post chemoradiation
was shown to be safe and tolerable with an AE profile consistent
with previously reported clinical trials.
- Interim pharmacodynamic data demonstrated statistically
significant superiority of the eight-week absolute lymphocyte count
with NKTR-255 post chemoradiation and in combination with
durvalumab versus non-contemporaneous control groups who received
either chemoradiation alone or chemoradiation in combination with
durvalumab. Additional pharmacodynamic findings following NKTR-255
administration show increased markers of NK cell proliferation and
activation.
About NKTR-255
NKTR-255 is a biologic that targets the IL-15 pathway in order
to activate the body's innate and adaptive immunity. Through
optimal engagement of the IL-15 receptor complex, NKTR-255 is
designed to enhance functional NK cell populations and formation of
long-term immunological memory to improve the anti-tumor immune
response.
In addition to studies in combination with CAR T cell therapies,
NKTR-255 is being studied in a Phase 1 clinical trial sponsored by
AbelZeta which is evaluating C-TIL051, a tumor-infiltrating
lymphocyte therapy, in anti-PD1 resistant metastatic non-small cell
lung cancer (NCT05676749). The JAVELIN Bladder Medley study
(NCT05327530), sponsored by Merck KGaA, is also ongoing to evaluate
NKTR-255 in combination with avelumab as a maintenance treatment in
patients with locally advanced or metastatic urothelial carcinoma
(NCT05327530).
About Nektar Therapeutics
Nektar Therapeutics is a clinical-stage biotechnology
company focused on developing treatments that address the
underlying immunological dysfunction in autoimmune and chronic
inflammatory diseases. Nektar's lead product candidate,
rezpegaldesleukin (REZPEG, or NKTR-358), is a novel, first-in-class
regulatory T cell stimulator being evaluated in two Phase
2b clinical trials, one in atopic
dermatitis and one in alopecia areata. Our pipeline also includes a
preclinical candidate NKTR-0165, which is a bivalent tumor necrosis
factor receptor type II agonist antibody. Nektar, together with
various partners, is also evaluating NKTR-255, an investigational
IL-15 receptor agonist designed to boost the immune system's
natural ability to fight cancer, in several ongoing clinical
trials. Nektar is headquartered in San
Francisco, California. For further information,
visit www.nektar.com and follow us on LinkedIn.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements which can
be identified by words such as: "will," "expect," "develop,"
"potential," "advance," "anticipate," "continue," and similar
references to future periods. Examples of forward-looking
statements include, among others, statements regarding the
therapeutic potential of, and future development plans for
NKTR-255. 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-255 are based on preclinical and clinical
findings and observations and are subject to change as research and
development continue; (ii) NKTR-255 is an investigational agent and
continued research and development for this drug candidate is
subject to substantial risks, including negative safety and
efficacy findings in future clinical studies (notwithstanding
positive findings in earlier preclinical and clinical studies);
(iii) NKTR-255 is in clinical development, and the risk of failure
is high and can unexpectedly occur at any stage prior to regulatory
approval; (iv) the timing of the commencement or end of clinical
trials and the availability of clinical data may be delayed or
unsuccessful due to challenges caused by 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; (v) patents may not issue from our
patent applications for our drug candidates, patents that have
issued may not be enforceable, or additional intellectual property
licenses from third parties may be required; and (vi) certain other
important risks and uncertainties set forth in our Quarterly Report
on Form 10-Q filed with the Securities and Exchange
Commission on August 9, 2024. 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:
Vivian Wu of Nektar
Therapeutics
628-895-0661
For Media:
Madelin Hawtin
LifeSci Communications
603-714-2638
mhawtin@lifescicomms.com
- NKTR-255, a novel polymer-conjugated rhIL-15 with potent
antitumor efficacyJ Immunother Cancer . 2021 May;9(5):e002024.
- A novel polymer-conjugated human IL-15 improves efficacy of
CD19-targeted CAR T-cell immunotherapy Hirayama A, et al. Blood
Advances 2022.
- A phase 1 clinical trial of NKTR-255 with CD19-22 CAR T-cell
therapy for refractory B-cell acute lymphoblastic leukemia
Srinagesh, Blood (2024). 144 (16): 1689–1698.
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