SAN FRANCISCO, Feb. 17, 2021 /PRNewswire/ -- Nektar Therapeutics
(NASDAQ: NKTR) announced today that it has entered into a clinical
trial collaboration and supply agreement with Merck (known as MSD
outside the United States and
Canada) for a Phase 2/3 study of
bempegaldesleukin (NKTR-214, BEMPEG), Nektar's investigational IL-2
pathway agent, in combination with Merck's KEYTRUDA®
(pembrolizumab) for first-line treatment of patients with
metastatic or unresectable recurrent squamous cell carcinoma of the
head and neck (SCCHN) whose tumors express PD-L1 (Combined Positive
Score [CPS] ≥1). The study is planned to start in the second
half of 2021.
"We are excited to advance the combination of BEMPEG plus
KEYTRUDA to a Phase 2/3 study in first-line squamous cell carcinoma
of the head and neck," said Jonathan
Zalevsky, PhD, Chief R&D Officer at Nektar.
"Earlier studies of BEMPEG in combination with immune
checkpoint inhibitors, also known as ICIs, evaluated in patients
with immune-sensitive cancers have shown the potential to increase
and deepen treatment responses as compared to historical rates for
ICIs alone. This collaboration with Merck will enable us to
further explore the combination of BEMPEG with the leading
checkpoint inhibitor therapy in the setting of advanced head and
neck cancer."
Under the terms of the agreement, Nektar will conduct the Phase
2/3 study, which is expected to enroll 500 patients with metastatic
or recurrent SCCHN with PD-L1 expressing tumors. Patients
will be randomized to receive either the combination of BEMPEG plus
pembrolizumab or pembrolizumab alone. The Phase 2 portion of
the study will include an interim analysis of overall response rate
(ORR) after the first 200 patients enrolled have a minimum follow
up of 4 months. If the ORR passes a prespecified futility
boundary, the study will continue, and the remaining 300 patients
will be enrolled to the Phase 3 portion of the study. The
primary endpoints of the trial are ORR and overall survival (OS);
progression free survival (PFS) is a secondary endpoint.
About Nektar
Nektar Therapeutics is a
biopharmaceutical company with a robust, wholly owned R&D
pipeline of investigational medicines in oncology, immunology, and
virology as well as a portfolio of approved partnered medicines.
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.
KEYTRUDA® is a registered trademark of Merck Sharp
& Dohme Corp., a subsidiary of Merck & Co., Inc.,
Kenilworth, NJ, USA.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking
statements which can be identified by words such as: "will,"
"develop," "may" and similar references to future periods. Examples
of forward-looking statements include, among others, statements we
make regarding the therapeutic potential of bempegaldesleukin
(BEMPEG) in combination with other agents (immune checkpoint
inhibitors), and the availability of results from clinical studies.
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, 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 bempegaldesleukin are based on preclinical and
clinical findings and the expected therapeutic potential for
bempegaldesleukin is subject to change as research and development
continue; (ii) bempegaldesleukin is in clinical development and the
risk of failure remains high and failure can unexpectedly occur at
any stage for one or more of the indications being studied prior to
regulatory approval due to lack of sufficient efficacy, safety
considerations or other factors that impact drug development; (iii)
data reported from ongoing preclinical and clinical trials are
necessarily interim data only and the final results will change
based on continuing observations; (iv) scientific discovery of new
medical breakthroughs is an inherently uncertain process and the
future success of potential new drug candidates (such as
bempegaldesleukin) is therefore very uncertain and unpredictable;
(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, delays caused by our collaboration partners and the
COVID-19 pandemic, and enrollment competition; (vi) 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 (vii)
certain other important risks and uncertainties set forth in
Nektar's Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission on November 6, 2020. 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:
Dan Budwick
of 1AB
973-271-6085
dan@1abmedia.com
View original content to download
multimedia:http://www.prnewswire.com/news-releases/nektar-announces-agreement-for-phase-23-study-of-il-2-pathway-agonist-bempegaldesleukin-in-combination-with-mercks-keytruda-pembrolizumab-in-patients-with-squamous-cell-carcinoma-of-the-head-and-neck-scchn-301229584.html
SOURCE Nektar Therapeutics