73% of the NKTR-255 treatment group compared
to 50% of the placebo group achieved a complete response at 6
months
NKTR-255 enhanced CAR T-cell kinetics with
improved CD8+ CAR-T area under the curve (AUC) 0-15 days
post-administration being 5.8-fold greater than
placebo-controls
SAN
FRANCISCO, Dec. 7, 2024 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today announced results of its Phase 2
proof-of-concept study evaluating NKTR-255 as an adjuvant treatment
to enhance complete response rate (CRR) and durability following
CD19-directed CAR-T therapy in patients with relapsed/refractory
(R/R) Large B-cell Lymphoma (LBCL) at the 66th ASH
Annual Meeting and Exposition in San
Diego, California.
NKTR-255 is an investigational polymer-conjugated IL-15 agonist,
that activates, proliferates and expands natural killer (NK) and
CD8+ T-cells in vivo, as well as promotes the survival and
expansion of memory CD8+ T cells intended to increase duration and
level of response for CAR-T and cellular
therapies.1,2
In this multicenter, double-blind Phase 2 study, patients were
randomized to receive one of three dose regimens of NKTR-255 or
placebo intravenously starting 14 days after CAR-T infusion. In the
fifteen-person clinical trial, the NKTR-255 combined treatment
group demonstrated an improved CRR at six months, achieving 73%
compared to 50% for the placebo, as assessed by a blinded
independent central radiology review. Additionally, two patients
treated with NKTR-255 converted from stable disease or partial
response to complete responses at six months. No conversions from
stable disease or partial response to complete response were
observed in the placebo arm of the trial.
"The majority of patients currently receiving CAR-T therapies
fail to achieve durable disease remission," said Sairah Ahmed, M.D., Associate Professor,
Director of CAR-T Program at the Department of Lymphoma/Myeloma,
Division of Cancer Medicine at University of
Texas MD Anderson Cancer Center. "The results of this study
demonstrated that NKTR-255 enhanced CAR T-cell counts and increased
the number of patients who achieve a CR at 6 months post infusion.
This finding is highly significant since, in multiple pivotal
trials, patients who achieved complete response at 6 months were
highly likely to remain in complete response beyond 2 years
translating to improved progression-free survival."
The reported clinical benefit surpasses the published historical
benchmark data from multiple pivotal trials and real-world
meta-analyses of currently available commercial CD19 CAR-T cell
therapies, which demonstrate 6-month complete response rates of 41%
to 44%.
"This study is the first randomized trial demonstrating adjuvant
treatment with NKTR-255 can enhance the durability of response to
standard-of-care commercial CAR T-cell therapy by modifying CAR
T-cell kinetics," said Mary
Tagliaferri, M.D., Chief Medical Officer of Nektar. "These
results contribute to the growing body of evidence demonstrating
the broad applicability of NKTR-255 in combination with cellular
therapies, and, as new data emerge, we continue to explore the best
path forward for this program."
NKTR-255 was safe and well-tolerated in patients with
relapsed/refractory LBCL in combination with FDA-approved CD19 CAR
T-cell products.
Details of the presentation can be found on Nektar's website at
www.nektar.com under Scientific Posters, Presentations and
Publications.
Title: 2068 NKTR-255 Vs Placebo to Enhance Complete
Responses and Durability Following CD19-Directed CAR-T Therapy in
Patients with Relapsed/ Refractory (R/R) Large B-Cell Lymphoma
(LBCL)
Poster: 2068
Program: Oral and Poster Abstracts
Session: 704. Cellular Immunotherapies: Early Phase Clinical
Trials and Toxicities: Poster I
Hematology Disease Topics & Pathways: Research, Clinical
trials, Clinical Research
Time & Date: Saturday, December 7,
2024, 5:30 PM-7:30 PM
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, which may lead to sustained and
durable 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 Pharma, Inc., 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.
Nektar's pipeline also includes a preclinical bivalent tumor
necrosis factor receptor type II (TNFR2) antibody and bispecific
programs, NKTR-0165 and NKTR-0166, and a modified hematopoietic
colony stimulating factor (CSF) protein, NKTR-422. 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 Nektar
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," "can," 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 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 November 8, 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.
For Investors:
Vivian Wu of Nektar
Therapeutics
628-895-0661
For Media:
Madelin Hawtin
LifeSci Communications
603-714-2638
mhawtin@lifescicomms.com
- Shah, N., Perales, M. A., Turtle, C. J., Cairo, M. S., Cowan, A. J., Saeed, H., …
Patel, K. K. (2021). Phase I Study Protocol: NKTR-255 as
Monotherapy or Combined with Daratumumab or Rituximab in
Hematologic Malignancies. Future
Oncology, 17(27), 3549–3560.
https://doi.org/10.2217/fon-2021-0576
- Miyazaki T, Maiti M, Hennessy M, et al. NKTR-255, a novel
polymer-conjugated rhIL-15 with potent antitumor efficacy.
Journal for ImmunoTherapy of Cancer 2021;9:e002024.
doi:10.1136/jitc-2020-002024
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