Full Press Release Details
Data Presented from PIVOT-02 Study of Bempegaldesleukin (NKTR-214) with Nivolumab in Metastatic Urothelial Carcinoma Patients
at the 2019 ASCO Genitourinary Cancers Symposium
conference call with urothelial cancer specialist to be held
2:00 p.m. Pacific Time today
FRANCISCO, February 15, 2019 -- Nektar Therapeutics (Nasdaq: NKTR) announced today a presentation of new clinical data for
bempegaldesleukin1 (NKTR-214) in combination with nivolumab in patients with first-line (1L) advanced or metastatic
urothelial carcinoma at the 2019 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium (GU) in San Francisco,
preliminary results from patients enrolled in the 1L urothelial cancer cohort in the ongoing PIVOT-02 Phase 1/2 study were shared
in a poster presentation today titled, "NKTR-214 + nivolumab in first-line advanced/metastatic urothelial carcinoma (mUC):
Updated results from PIVOT-02" by Arlene O. Siefker-Radtke, M.D., Professor, Department of Genitourinary Medical Oncology,
Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center and Clinical Co-Leader of the Bladder Cancer
SPORE Executive Committee.
data from the ongoing PIVOT-02 trial in metastatic urothelial cancer patients demonstrated important response rates, including
complete responses, in patients who were cisplatin-ineligible or refused standard of care," said Mary Tagliaferri, M.D.,
Chief Medical Officer of Nektar Therapeutics. "These responses were observed regardless of baseline PD-L1 expression and
no relapses occurred. In this cohort of Stage IV bladder cancer patients with a median age of 70, the combination therapy was
generally well tolerated with no Grade 4 or 5 adverse events reported. Of note, our translational research demonstrated that in
patients with the highest unmet medical need - those whose tumors did not express PD-L1 at their baseline scan - treatment
with the combination resulted in 70 percent of patients converting to PD-L1 positive expressors. These data support our development
strategy in this tumor setting, including the Phase 2 PIVOT-10 study underway in cisplatin-ineligible urothelial cancer patients
with low PD-L1 tumor expressors."
from the ASCO-GU presentation in 1L metastatic urothelial carcinoma patients include:
measured per RECIST 1.1 for per protocol efficacy-evaluable patients treated at the recommended Phase 2 dose (RP2D) and
with 1 post-treatment scan as of December 3, 20182:
and Mechanism of Action
copy of Dr. Siefker-Radtke's poster presentation of PIVOT-02 data is available on Nektar's corporate website at https://www.nektar.com/download_file/656/0.
2 Efficacy-evaluable
defined per protocol as patients with at least one post-baseline scan. As of 12/3/2018, one patient was excluded for non-eligibility
(no target lesion), and three patients discontinued prior to first scan (one due to patient decision; one due to clinical progression;
one due to death from disease); ten patients pending first scan in database.
3 ORR by primary investigator
assessment included four unconfirmed responses: two patients with uPR and one patient with uCR pending confirmatory scan and one
patient with uPR discontinued for AE after first scan with no confirmatory scan. Since 12/3/2018, three of four patients have
had scans confirming responses (including CR).
symptoms includes preferred terms: chills, influenza, influenza-like illness, pyrexia
PIVOT-10 study evaluating bempegaldesleukin in combination with nivolumab in 1L locally advanced or metastatic urothelial carcinoma
cisplatin-ineligible patients with low PD-L1 expression is currently recruiting patients (NCT03785925).
Call with Urothelial Cancer Specialist
will webcast an analyst conference call featuring Dr. Siefker-Radtke today, Friday, February 15, 2019 at 2:00 p.m. Pacific Time.
The conference call may be accessed by dialing 877-881-2183 (toll-free) or 970-315-0453 (international) with the conference call
passcode 9688945. The webcast and slides for the conference call can be accessed through a link posted on the Investors section
of the Nektar website at https://ir.nektar.com. The webcast of the conference call will be available for replay through
Bempegaldesleukin (NKTR-214)
is an investigational, first-in-class, CD-122-preferential IL-2 pathway agonist designed to provide rapid activation and proliferation
of cancer-killing immune cells, known as CD8+ effector T cells and natural killer (NK) cells, without over activating the immune
system. Bempegaldesleukin stimulates these cancer-killing immune cells in the body by targeting CD122 specific receptors found
on the surface of these immune cells. CD122, which is also known as the Interleukin-2 receptor beta subunit, is a key signaling
receptor that is known to increase proliferation of these effector T cells.5 In clinical and preclinical studies, treatment
with bempegaldesleukin resulted in expansion of these cells and mobilization into the tumor micro-environment.6,7 Bempegaldesleukin
has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.
Therapeutics is a research-based development stage 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 www.nektar.com.
Boyman, J., et al., Nature Reviews Immunology, 2012, 12, 180-190.
Charych, D., et al., Clin Can Res; 22(3) February 1, 2016
Journal for ImmunoTherapy of Cancer 2016, 4(Suppl 1): P369
press release contains forward-looking statements which can be identified by words such as: "will," "may,"
"designed" and similar references to future periods. Examples of forward-looking statements include, among others,
statements we make regarding the therapeutic potential bempegaldesleukin in combination with other therapeutic agents, and the
availability of results and outcomes from our clinical and preclinical 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 observations to date from ongoing clinical studies; (ii) bempegaldesleukin is in early stage clinical development
and the risk of failure remains high and failure can unexpectedly occur at any stage for one or more of the cancer indications
being studied prior to regulatory approval due to lack of sufficient efficacy, safety considerations or other factors that negatively
impact drug development; (iii) data reported from ongoing clinical trials is necessarily interim data only and the final results
will change based on continuing observations from patients that currently remain enrolled in the trials and new observations from
patients enrolling in the trials; (iv) scientific discovery of new medical breakthroughs is an inherently uncertain process and
the future regulatory approval of potential new drug candidates (such as bempegaldesleukin) is therefore very uncertain and unpredictable;
(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 Nektar's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 8, 2018.
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.
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Barreto of Nektar Therapeutics
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