Targeted, Oral Agent Enzastaurin Shows Favorable Results in Late-Stage Lung Cancer
03 June 2007 - 12:00AM
PR Newswire (US)
Study Supports Lilly's Commitment to Advances in Lung Cancer
Treatment CHICAGO, June 2 /PRNewswire-FirstCall/ -- Enzastaurin, an
investigational targeted, oral agent under development by Eli Lilly
and Company, showed encouraging results in treating patients with
late-stage non-small cell lung cancer (NSCLC), according to data
presented today at the 43rd Annual Meeting of the American Society
of Clinical Oncology (ASCO). The data presented were gathered from
a multicenter Phase II study of enzastaurin as a second- or
third-line treatment of NSCLC (ASCO Abstract #7543(i)). The
rationale for the study was based on enzastaurin's unique mechanism
of action as a serine/threonine kinase inhibitor, which is believed
to suppress signaling through the PKC-beta and PI3K/AKT pathways.
Historically, over-expression and activity of PKC-beta and PI3K/AKT
have been associated with poor prognosis and treatment resistance
in NSCLC. The primary objective of the study was progression-free
survival at six months. Secondary endpoints were safety and overall
survival at 12 months. "These data in NSCLC shed new light on the
potential versatility of this agent," said Richard Gaynor, M.D.,
vice president, cancer research and global oncology platform leader
for Lilly. "Our objective with enzastaurin is to continue
investigating the efficacy and safety of this unique molecule in
order to determine the diseases where enzastaurin could have the
most positive impact on patients." In the study, patients received
500 mg of oral enzastaurin, once daily, until disease progression
or unacceptable toxicity occurred. In the 54 patients enrolled, the
median progression-free survival was 1.9 months (95% Confidence
Interval: 1.7-1.9) and the progression-free survival rate at six
months was 14% (95% CI: 4.4%-23.6%). The median overall survival
was 9.9 months (95% CI: 6.5-14.6). The overall survival rate at 12
months was 46.3% (95% CI: 32.1%-60.5%). The most common toxicity
was fatigue. Additional toxicities observed included ataxia (n=1),
thromboembolism (n=1), anemia (n=1) and dizziness. "Based on the
encouraging survival and tolerability data gathered thus far,
further evaluation of enzastaurin in NSCLC, as a single agent or in
combination, is warranted," said chief investigator for the study,
Gerold Bepler, M.D., Ph.D., chief of thoracic oncology at the H.
Lee Moffitt Cancer Center and Research Institute in Tampa, Florida.
Additional data presented at ASCO this year examined studies of
enzastaurin in breast cancer, first-line glioblastoma, ovarian and
pancreatic cancers, as well as other solid tumors. Specifically,
the data included: testing enzastaurin on cell signaling,
proliferation and apoptosis in breast cancer, testing in Phase I/II
with radiation combination therapy for first- line treatment of
glioblastoma multiforme, a pre-clinical study on ovarian
chemo-resistant cancer cell lines, testing for growth suppression
in pancreatic cancer, as well as dosage testing on other solid
tumors. "Through a constant stream of innovation, we remain
committed to fighting cancer," said Gaynor. "By aggressively
studying enzastaurin across multiple tumor types, we believe that
we will find appropriate and innovative uses for this targeted
therapy to help benefit patients." Enzastaurin Enzastaurin is an
oral, serine threonine kinase inhibitor which selectively targets
the PKC-beta and PI3K/AKT signaling pathways. By blocking these key
pathways frequently over-expressed in a wide variety of cancers,
enzastaurin suppresses tumor cell proliferation, induces tumor cell
death and inhibits tumor-induced angiogenesis. Enzastaurin is being
evaluated in a Phase III trial (currently enrolling patients) as a
maintenance therapy for the treatment of diffuse large B-cell
lymphoma (DLBCL), as well as being evaluated in several Phase II
studies across a variety of more common tumor types including:
breast, colon, lung, ovarian and prostate cancers. More details on
the enzastaurin Phase III trial, as well as information on global
recruitment sites, may be found at http://www.clinicaltrials.gov/,
http://www.lillytrials.com/ or by calling 1-877-CTLilly
(1-877-285-4559). About Lilly Oncology, a Division of Eli Lilly and
Company For more than four decades, Lilly Oncology has been
collaborating with cancer researchers to deliver innovative
treatment choices and valuable programs to patients and their
physicians. Inspired by courageous patients living with cancer,
Lilly Oncology is providing treatments that are considered global
standards of care and developing a broad portfolio of novel
targeted therapies to accelerate the pace and progress of cancer
care. To learn more about Lilly's commitment to cancer, please
visit http://www.lillyoncology.com/. About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of first-in-class and best-in-class
pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent
scientific organizations. Headquartered in Indianapolis, Ind.,
Lilly provides answers -- through medicines and information -- for
some of the world's most urgent medical needs. P-LLY enzastaurin,
Lilly This press release contains forward-looking statements about
the potential of the investigational compound enzastaurin
(LY317615) and reflects Lilly's current beliefs. However, as with
any pharmaceutical product under development, there are substantial
risks and uncertainties in the process of development and
regulatory review. There is no guarantee that the product will
receive regulatory approvals, or that the regulatory approval will
be for the indication(s) anticipated by the company. There is also
no guarantee that the product will prove to be commercially
successful. For further discussion of these and other risks and
uncertainties, see Lilly's filings with the United States
Securities and Exchange Commission. Lilly undertakes no duty to
update forward-looking statements. (i) Bepler, G, Oh Y, et al. A
phase II study of enzastaurin in second- or third-line treatment of
non-small cell lung cancer (NSCLC). Abstract # 7543. American
Society of Clinical Oncology (ASCO) Annual Meeting 2007. (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: Christine Van Marter, Lilly,
+1-317-651-1473, mobile, +1-317-554-7923, ; or Neil Hochman, CPR
Worldwide, +1-212-453-2067, mobile, +1-516-784-9089,
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