Nektar Announces Initiation of Investigator-Initiated Trial Evaluating Etirinotecan Pegol (NKTR-102) as a Third-Line Treatment

    Nektar Announces Initiation of Investigator-Initiated Trial Evaluating
   Etirinotecan Pegol (NKTR-102) as a Third-Line Treatment in Patients with
         Metastatic and Recurrent Non-Small Cell Lung Cancer (NSCLC)

PR Newswire

SAN FRANCISCO, Feb. 5, 2013

SAN FRANCISCO, Feb. 5, 2013 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR)
announced today the start of a Phase 2 investigator-initiated study of
etirinotecan pegol in patients with metastatic and recurrent NSCLC. The study
is being conducted at the Abramson Cancer Center of the University of
Pennsylvania under the direction of Charu Aggarwal, M.D., M.P.H., Assistant
Professor of Oncology and Corey Langer, M.D., Professor of Oncology.

"Patients with metastatic or recurrent non-small cell lung cancer currently
have no standard treatment options after failure of second-line treatment,"
said Dr. Aggarwal. "In Phase 1 studies, etirinotecan pegol demonstrated
encouraging anti-tumor activity in a broad range of solid tumors including
non-small cell lung cancer. We are highly interested in evaluating
etirinotecan pegol as a potential treatment option for this patient

The primary endpoint of the Phase 2 study is overall response rate (ORR).
Secondary endpoints include progression free survival (PFS), overall survival
(OS), median duration of response (DoR) and the safety profile of etirinotecan
pegol in patients with NSCLC after failure of second-line therapy. The open
label, single-arm trial is expected to enroll approximately 37 patients who
will receive etirinotecan pegol once every three weeks as monotherapy.

"We are very pleased that Dr. Aggarwal and Dr. Langer have identified and
proposed this study of single-agent etirinotecan pegol in patients with this
difficult to treat cancer," said Robert Medve, M.D., Senior Vice President and
Chief Medical Officer of Nektar Therapeutics. "We are pleased that there has
been so much interest in etirinotecan pegol from the oncology community. The
results of these studies will provide us with a greater understanding of the
potential of etirinotecan pegol to benefit patients in need of new treatment


Lung cancer is the leading cause of cancer-related mortality in the US with
NSCLC accounting for approximately 85% of all lung cancer diagnoses [1]. Most
NSCLC patients present with loco-regionally advanced or metastatic disease.
Platinum-based chemotherapy is the mainstay of treatment for NSCLC in the
first-line setting for metastatic disease. Even after response to first-line
therapy, patients eventually develop progressive disease and require
additional treatment. Currently, pemetrexed, docetaxel, and erlotinib are the
only FDA approved agents in the second line setting. Erlotinib is the only
agent approved for use in the third-line setting, however, progression-free
survival and overall survival remain suboptimal and there are no cytotoxics
formally approved to treat patients in the third-line setting. Consequently,
there is a need for new therapies that are safe and effective, which may
improve overall survival and quality of life.

About Etirinotecan Pegol

Etirinotecan pegol is a unique, targeted topoisomerase I inhibitor designed
for prolonged tumor cell exposure. Etirinotecan pegol is believed to penetrate
the vasculature of the tumor environment more readily than normal vasculature,
increasing the concentration of active drug within tumor tissue to enhance
anti-tumor activity. The BEACON study is a Phase 3 clinical study currently
evaluating etirinotecan pegol for the treatment of locally recurrent or
metastatic breast cancer.  In addition to metastatic breast cancer,
etirinotecan pegol is also being evaluated for the treatment of ovarian,
colorectal and glioma cancers.

About Nektar

Nektar Therapeutics is a biopharmaceutical company developing novel
therapeutics based on its PEGylation and advanced polymer conjugation
technology platforms. Nektar has a robust R&D pipeline of potentially
high-value therapeutics in oncology, pain and other therapeutic areas. In the
area of pain, Nektar has an exclusive worldwide license agreement with
AstraZeneca for naloxegol (NKTR-118), an investigational drug candidate, which
is being evaluated in Phase 3 clinical studies as a once- daily, oral tablet
for the treatment of opioid-induced constipation. This agreement also
includes NKTR-119, an earlier stage development program that is a
co-formulation of naloxegol and an opioid. NKTR-181, a novel mu-opioid
analgesic candidate for chronic pain conditions, is in Phase 2 development in
osteoarthritis patients with chronic knee pain. NKTR-192, a novel mu-opioid
analgesic in development to treat acute pain is in Phase 1 clinical
development. In oncology, etirinotecan pegol (NKTR-102) is being evaluated in
a Phase 3 clinical study (the BEACON study) for the treatment of metastatic
breast cancer and is also in Phase 2 studies for the treatment of ovarian and
colorectal cancers.

Nektar's technology has enabled eight approved products in the U.S. or Europe
through partnerships with leading biopharmaceutical companies, including
Affymax's OMONTYS® for anemia, UCB's Cimzia® for Crohn's disease and
rheumatoid arthritis, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta®
for neutropenia. Additional development-stage products that leverage Nektar's
proprietary technology platform include Baxter's BAX 855, a long-acting
PEGylated rFVIII program, which is in Phase 3 clinical development.

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

Nektar Investor Inquiries:
Jennifer Ruddock/Nektar Therapeutics                      (415) 482-5585
Susan Noonan/SA Noonan Communications, LLC                (212) 966-3650
Nektar Media Inquiries:  
Amanda Connolly/MSL      (404) 870-6865
Mike Huckman /MSL                                         (646) 500-7631

1.Siegel, R., D. Naishadham, and A. Jemal, Cancer statistics, 2012. CA Cancer
J Clin, 2012. 62(1): p. 10-29.

SOURCE Nektar Therapeutics

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