Data Monitoring Committee Recommends Closing Enrollment in Recurrent Glioblastoma Study
December 21 2006 - 6:00AM
PR Newswire (US)
- Other Enzastaurin Trials Unaffected - INDIANAPOLIS, Dec. 21
/PRNewswire-FirstCall/ -- After reviewing data gathered to date, as
part of a planned interim analysis, an External Data Monitoring
Committee (DMC) has recommended that the STEERING trial (Study
Evaluating Enzastaurin in Recurrent Glioblastoma) be closed for
enrollment. The global Phase III study was evaluating enzastaurin
for the treatment of an aggressive and recurrent form of brain
cancer. Results of this planned interim analysis suggested that
enzastaurin would not meet the primary endpoint of improvement in
progression-free survival over an existing chemotherapy in this
particular study. Lilly accepted the DMC recommendation and
immediately contacted all STEERING study investigators to inform
them of the decision and to provide them all available information
to manage patients. "We are disappointed for patients suffering
from recurrent glioblastoma, but we remain confident and committed
to the development of enzastaurin," said Richard Gaynor, M.D., vice
president, cancer research and global oncology platform leader for
Eli Lilly and Company. "Recurrent glioblastoma is a rare and
difficult to treat tumor and patients and their families are
seeking innovative treatment options. Given the independently
validated response rate of 22-percent in a phase II trial, we plan
to thoroughly review the data from this interim analysis and apply
the insights learned to the glioblastoma program. Based on
preclinical and clinical evidence, the company also remains fully
committed to the continued development of enzastaurin." Enzastaurin
is being evaluated in a Phase III trial (currently enrolling
patients) as a maintenance therapy for the treatment of
non-Hodgkin's lymphoma 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. These additional
trials are unaffected by the DMC recommendation. Enzastaurin
Enzastaurin is a potent multi-kinase inhibitor which targets
selectively the PKCbeta and PI3/AKTsignaling 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. As
further evidence to the rare and unmet medical need of recurrent
glioblastoma, enzastaurin was granted orphan drug designation by
the European Agency for the Evaluation of Medicinal Products (EMEA)
and by the U.S. Food and Drug Administration's Office of Orphan
Products Development for the treatment of glioblastoma. Background
on STEERING Trial The STEERING trial (Study Evaluating Enzastaurin
in Recurrent Glioblastoma) is a randomized, open label registration
study in recurrent glioblastoma multiforme (GBM) comparing the
efficacy and safety of enzastaurin, taken orally, versus CeeNU(R)
(lomustine[CCNU]), a chemotherapy used to treat this disease. The
primary endpoint is improvement in progression-free survival.
Glioblastoma Glioblastoma is the most aggressive and malignant form
of glioma, a type of primary brain cancer. In the early stages,
glioblastoma tumors often grow quickly and without symptoms,
becoming quite large before signs of altered brain function arise.
Surgery is generally the first line of treatment, followed by
radiation and/or chemotherapy. Although primary treatment is often
successful in temporarily stopping the progression of the tumor,
glioblastomas almost always recur and survival rates remain low.
Data Monitoring Committee A Data Monitoring Committee (DMC) is an
independent body consisting of physicians and statisticians. Their
responsibility is to review interim analysis data from clinical
trials and make a decision on whether the trial is still set up
correctly or needs any modifications. 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
physicians worldwide. Inspired by the 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. Additional
information about Lilly is available at http://www.lilly.com/.
O-LLY This press release contains forward-looking statements about
the potential of the investigational compound enzastaurin 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 filing with the United States Securities
and Exchange Commission. Lilly undertakes no duty to update
forward-looking statements. CeeNU(R) (lomustine [CCNU], Bristol
Myers Squibb) (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 of Eli Lilly
and Company, +1-317-651-1473,
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