Nektar Therapeutics Announces Positive Topline Results for NKTR-102 From First Stage of Phase 2 Study in Platinum-Resistant Ovarian Cancer
SAN CARLOS, Calif., Jan. 12 /PRNewswire-FirstCall/ -- Nektar
Therapeutics (NASDAQ:NKTR) today announced preliminary
results from the first stage of a two-stage Phase 2 clinical study
evaluating NKTR-102 in women with platinum-resistant ovarian
cancer. In the first stage of the study, 39 patients enrolled with
platinum-resistant disease were evaluable for the primary endpoint
of overall response rate using Gynecologic Cancer InterGroup (GCIG)
criteria, i.e., a combination of response by tumor imaging (RECIST)
and/or ovarian cancer biomarker (CA-125) criteria(1). The first
stage of the NKTR-102 Phase 2 study showed an overall GCIG response
rate of 32% (6/19) in the once every 14 days (q14 day) dose
schedule and 35% (7/20) for the once every 21 days (q21 day) dose
schedule. Confirmed objective response rates using RECIST were 21%
(4/19) and 22% (4/18) for the q14 day and q21 day dose schedules,
respectively. CA-125 response rates were 31% (5/16) and 38% (6/16),
for each dose schedule, respectively. The Phase 2 study has now
completed enrollment with a total of 71 patients. Approximately
one-third of the patients in the study remain on NKTR-102
treatment, including a number of patients in the first stage of the
study.
"The early and dramatic reductions in CA-125 in many of the
patients with platinum-resistant and refractory ovarian cancer
indicate that NKTR-102 has great therapeutic potential," said Prof.
Dr. Ignace Vergote, Head of the Department of Obstetrics and
Gynaecology and Gynaecologic Oncology at the Catholic University of
Leuven, European Union and Lead Investigator of the NKTR-102 study.
"NKTR-102 is one of the most promising agents for
platinum-resistant ovarian cancer I have seen in 25 years, as
evidenced by the number of women in the study with tumor response
and rapid biochemical response. This drug warrants further
definitive Phase 3 testing as quickly as possible. The
investigators look forward to presenting the final data at an
upcoming scientific meeting."
The most commonly observed grade 3 or grade 4 side effects in
the study to date (every 14 day/every 21 day dose schedule) were
diarrhea (29%/10%) and neutropenia (14%/10%).
"This population of heavily pre-treated patients, which includes
a high proportion of women with platinum-refractory disease, is
among the most challenging to treat in oncology," said Lorianne
Masuoka, M.D., Senior Vice President and Chief Medical Officer.
"Almost half of the patients in the first stage of our study had
platinum-refractory disease, having progressed within three weeks
of their last platinum regimen. We are highly encouraged by the
compelling efficacy seen to-date in the patients from the first
stage of our study. This efficacy is accompanied by a favorable
safety profile with regard to both GI side effects and
neutropenia."
About the Study
The Phase 2 study is evaluating two dose regimens (q14 day and
q21 day) of single-agent NKTR-102 in women with platinum-resistant
ovarian cancer. The study employs a two-stage design, with 41
patients in the first stage and 30 patients in the second stage.
Two patients in the q14 day dose regimen in the first stage had
platinum-sensitive disease and were not evaluable for the primary
outcome measure. 44% of the patients in the first stage were
platinum-refractory, having progressed within three weeks of their
last platinum therapy. 77% of the patients in the first stage had a
platinum-free interval of less than three months (progression
within three months of last platinum therapy). Secondary endpoints
of the Phase 2 study include progression-free survival and
safety.
CA-125 is a biochemical marker that is found in the blood of
ovarian cancer patients and is measured to assess disease
progression and recurrence. RECIST classifies response based upon
tumor reduction measured by imaging methods.
Ovarian cancer is the fifth leading cause of cancer deaths among
women, accounting for more deaths than any other cancer of the
female reproductive system(2). Agents currently approved by the
U.S. Food & Drug Administration to treat women with
platinum-resistant ovarian cancer have modest overall response
rates of between 6.5 to 13.8%(3,4).
About NKTR-102
Nektar is developing NKTR-102, a topoisomerase I
inhibitor-polymer conjugate with reduced peak concentrations and a
continuous concentration profile. NKTR-102 was invented by Nektar
using its advanced polymer conjugate technology platform, and is
the first oncology product candidate to leverage Nektar's
releasable polymer technology platform.
In addition to the fully-enrolled Phase 2 study currently
underway in platinum-resistant ovarian cancer, NKTR-102 is also
being tested in two separate Phase 2 clinical trials in patients
with metastatic breast cancer and second-line colorectal
cancer.
The company also announced today that it has opened the second
stage of its Phase 2 study of NKTR-102 in women with metastatic
breast cancer evaluating two dose regimens (q14 and q21 day dose
schedules). Enrollment of the first stage of this two-stage study
is complete for both regimens (20 patients per regimen).
About Nektar
Nektar Therapeutics is a biopharmaceutical company developing
novel therapeutics based on its PEGylation and advanced polymer
conjugation technology platforms. Nektar's technology and drug
development expertise have enabled nine approved products in the
U.S. or Europe for leading biopharmaceutical company partners,
including UCB's Cimzia(R) for Crohn's disease and rheumatoid
arthritis, Roche's PEGASYS(R) for hepatitis C and Amgen's
Neulasta(R) for neutropenia.
Nektar has created a robust pipeline of potentially high-value
therapeutics to address unmet medical needs by leveraging and
expanding its technology platforms to improve and enable molecules.
In addition to the releasable polymer technology, Nektar is the
first company to create a permanent small molecule-polymer
conjugate with enhanced oral bioavailability and restricted entry
into the CNS. Nektar is currently conducting clinical and
preclinical programs in oncology, pain and other therapeutic areas.
Nektar recently entered into an exclusive worldwide license
agreement with AstraZeneca for its oral NKTR-118 program to treat
opioid-induced constipation and its NKTR-119 program for the
treatment of pain without constipation side effects. NKTR-102 is
being evaluated in Phase 2 clinical studies for the treatment of
ovarian, breast and colorectal cancers. NKTR-105 is in a Phase 1
clinical study in cancer patients with refractory solid
tumors.
Nektar is headquartered in San Carlos, California, with
additional R&D 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/.
This press release contains forward-looking statements that
reflect the company's current views regarding the potential of the
company's technology platforms, the potential of NKTR-102,
preliminary results from stage 1 of a Phase 2 study for NKTR-102 in
ovarian cancer, and an update on the status of a two stage Phase 2
study of NKTR-102 in breast cancer. These forward-looking
statements involve substantial risks and uncertainties, including
but not limited to one or more of the following: (i) NKTR-102 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 (i.e. ovarian cancer,
breast cancer, and colorectal cancer) prior to regulatory approval
due to efficacy, safety or other factors; (ii) the timing or
success of the commencement or end of clinical trials and
commercial launch of new drugs may be delayed or unsuccessful due
to regulatory delays, clinical trial design, slower than
anticipated patient enrollment, drug manufacturing challenges,
changing standards of care, clinical outcomes, or delay or failure
in obtaining regulatory approval in one or more important markets;
(iii) the preliminary Phase 2 results for NKTR-102 in ovarian
cancer patients in stage 1 described in this press release is
preliminary data only and remains subject to final data gathering
and analysis review procedures; (iv) the preliminary results from
stage 1 of the NKTR-102 clinical study for ovarian cancer is not
necessarily indicative or predictive of the future results from
stage 2 of this clinical study and therefore the outcome remains
uncertain; (v) the company's patent applications for its
proprietary or partner product candidates may not issue, patents
that have issued may not be enforceable, or intellectual property
licenses from third parties may be required in the future; (vi) the
data from clinical studies in Nektar-102 from any particular cancer
indication is not necessarily predictive of the outcomes for other
cancer indications for which NKTR-102 is being studied by the
company; (vii) the company's patent applications for its
proprietary or partner product candidates may not issue, patents
that have issued may not be enforceable, or intellectual property
licenses from third parties may be required; and (vii) the outcome
of any existing or future intellectual property or other litigation
related to the company's proprietary product candidates including
without limitation NKTR-102. Other important risks and
uncertainties are detailed in the company's reports and other
filings with the Securities and Exchange Commission, including its
most recent Quarterly Report on Form 10-Q and Annual Report on Form
10-K. Nektar undertakes no obligation to update forward-looking
statements, whether as a result of new information, future events
or otherwise.
Nektar Investor Inquiries: Jennifer Ruddock/Nektar Therapeutics (650) 631-4954 Susan Noonan/SAN Group (212) 966-3650 Nektar Media Inquiries: Karen Bergman/BCC Partners (650) 575-1509 Michelle Corral/BCC Partners (415) 794-8662
(1) 2008 International Gynecologic Cancer Society. Gynecological
Cancer Intergroup, http://www.gcig.igcs.org/CA-125.html
(2) American Cancer Society, 2009. (3) Gordon et al., Journal of Clinical Oncology 2001, 19: 3312-3322 (4) Doxil US Package Insert, 2008. http://www.doxil.com/
Source: Nektar Therapeutics
CONTACT: Nektar Investor Inquiries, Jennifer Ruddock,
Nektar
Therapeutics, +1-650-631-4954, or Susan Noonan, SAN Group,
+1-212-966-3650;
Nektar Media Inquiries, Karen Bergman, +1-650-575-1509, or Michelle
Corral,
+1-415-794-8662, both of BCC Partners
Web Site: http://www.nektar.com/
Posted: January 2010
