Lilly Oncology Prepares for Strong Showing at ASCO 2006; Targets Breast Cancer and Other Tumors with 79 Studies
23 May 2006 - 11:00PM
PR Newswire (US)
11 breast cancer studies; 29 thoracic cancer studies; and 8 studies
with developing targeted agent INDIANAPOLIS, May 23
/PRNewswire-FirstCall/ -- Lilly Oncology, a global leader in
thoracic cancer treatment, will be presenting important data on its
emerging research in breast cancer therapy at the 42nd annual
American Society for Clinical Oncology (ASCO) meeting in Atlanta,
Ga., June 2-6, 2006. Among the 79 studies being presented by Lilly
Oncology, data from 11 clinical studies focus on the treatment of
advanced breast cancer. Eight of Lilly's studies contain data on
its investigational, oral targeted agent enzastaurin across
multiple tumors. "With 79 abstracts around 3 Lilly molecules, ASCO
2006 is definitely big for us," said Richard Gaynor, M.D., vice
president, cancer research and global oncology platform leader for
Lilly. "One of the things that people will notice is that Lilly
Oncology is truly at the forefront of scientific development,
demonstrated in our innovative studies employing biomarkers and
pharmacogenomics in clinical research around chemotherapy agents to
strive to ensure better patient outcomes." Key Lilly Abstracts for
ASCO 2006: -- GEMZAR(R) (gemcitabine HCl) - Title: Expression
profiles can predict chemotherapy response in breast cancer
patients, #10008 - Date: Sat., June 3, 4:45 pm -- ALIMTA(R)
(pemetrexed) - Title: Phase II Study of Alimta as first-line
therapy for advanced breast cancer, #3077 - Date: Sun., June 4,
2:00 pm -- ALIMTA - Title: Three-year survival update for Alimta in
second-line non- small cell lung cancer, #7133 - Date: Sun., June
4, 8:00 am Lilly Oncology ASCO Information -- GEMZAR, celebrating
its 10th anniversary in the US, is the subject of more than 155
trials, as Lilly agents are the foundation of new treatments which
combine chemotherapy and targeted agents -- ALIMTA, Lilly's
innovative chemotherapy agent that is delivered via a 10-minute
infusion and showed virtually no hair loss in clinical trials, is
the subject of 27 trials, as another foundational agent with new
treatments combining chemotherapy and targeted agents -- Lilly
Oncology prepares to unveil data from innovative research featuring
ALIMTA and GEMZAR to evaluate use of patient biomarkers to predict
chemotherapy response in breast cancer patients -- Enzastaurin is
currently being investigated in a global Phase III trial for the
treatment of glioblastoma (primary brain cancer). Information on
another Phase III trial for enzastaurin will be forthcoming. For
detailed information on ALIMTA and GEMZAR, please view the attached
fact sheets. Facts About Gemzar(R) Product Description: Gemzar(R)
(gemcitabine HCl) is an anticancer drug that interferes with the
processes of DNA production; by doing so, Gemzar prevents cancer
cells from replicating and thus slows or stops tumor growth.
History: Discovered and developed by scientists at Eli Lilly and
Company, Gemzar has three regulatory approvals in the United States
and is also approved for use in more than 90 countries worldwide.
-- In the United States, Gemzar has been approved for the treatment
of advanced pancreatic cancer since 1996 and, in combination with
cisplatin, for the treatment of advanced non-small cell lung cancer
since 1998. In 2004, Gemzar, in combination with Taxol(R)
(paclitaxel), received approval for the first-line treatment of
metastatic breast cancer. -- In most European countries, Gemzar has
been approved as a single agent or in combination with cisplatin
for the treatment of advanced non-small cell lung cancer since
1996. Gemzar has also been approved as a single agent for the
treatment of advanced pancreatic cancer in most European countries
since the mid 1990's. Moreover, Gemzar has been approved, in
combination with Taxol, for the treatment of metastatic breast
cancer in more than 60 countries. -- In August of 2004, regulatory
officials in several European markets including Germany, Sweden,
Denmark, Finland, Belgium, Hungary, Portugal, and Romania approved
Gemzar in combination with carboplatin for the treatment of
recurrent epithelial ovarian cancer. -- Gemzar, in combination with
cisplatin, was recently approved in Mexico as a first-line
treatment for locally advanced or metastatic cervical cancer, the
leading cause of cancer deaths among women in developing countries.
In addition, a Gemzar-cisplatin-radiation combination has been
approved by Mexican regulators for patients with locally advanced
cervical cancer that cannot be removed through surgery. This marks
the first approval for this disease, and the sixth indication for
Gemzar in various countries since its original launch in 1996 in
the United States for pancreatic cancer. -- Gemzar is approved in
several different countries for the treatment of bladder cancer.
Key Statistics: Nearly nine out of every 10 patients diagnosed with
pancreatic cancer in the United States and the EU today receives
treatment with Gemzar. About one of every four patients diagnosed
with non-small cell lung cancer in the United States today is
treated with Gemzar-based therapy. Global sales of Gemzar reached
$1.3 billion in 2005. How Gemzar Is Administered: The treatment
schedule used depends on the patient's general physical health, the
type of cancer and at what stage it was diagnosed. Typically,
patients receive an infusion of Gemzar on an outpatient basis once
a week for two or three weeks in a row, followed by a week without
treatment. Other Clinical Research: Gemzar is the focus of clinical
research in many types of cancers, including gastric and lymphoma.
For full prescribing information visit Gemzar.com Gemzar(R)
(gemcitabine HCl), Lilly. Taxol(R) (paclitaxel), Bristol-Myers
Squibb Updated: March, 2006 Facts About Alimta(R) Product
Description: Alimta(R) (pemetrexed), an antifolate, simultaneously
blocks three separate enzyme targets important to the formation of
basic building blocks by which cancer cells grow and divide.
Approvals and Other Regulatory Milestones: -- In August 2004, the
U.S. Food and Drug Administration (FDA) granted accelerated
approval to Alimta as a second-line therapy for locally advanced or
metastatic non-small cell lung cancer. -- In February 2004, Alimta,
in combination with cisplatin, was approved by the FDA as the first
treatment for malignant pleural mesothelioma, a cancer of the
lining of the lungs often associated with asbestos exposure. --
Alimta is also approved, with cisplatin, for the treatment of
malignant pleural mesothelioma in Canada, Israel, Argentina, New
Zealand and Australia. In Australia, Alimta is also approved as a
single-agent for the treatment of second-line non-small cell lung
cancer. -- In September 2004, the European Commission granted
approval for Alimta/cisplatin in malignant pleural mesothelioma and
single-agent Alimta in second-line non-small cell lung cancer. This
approval for a dual indication represents a regulatory first for
Eli Lilly and Company. Several countries have now approved Alimta
for use in malignant pleural mesothelioma and second- line
non-small cell lung cancer. Clinical Data: Mesothelioma: In the
largest Phase III trial conducted in malignant pleural
mesothelioma, Alimta/cisplatin increased the average patient's
survival to 12.1 months, longer than any therapy to date. A total
of 50.3 percent of patients treated with Alimta/cisplatin were
alive a year later compared to 38 percent treated with cisplatin
alone. Second-Line Treatment of Non-Small Cell Lung Cancer: In the
largest head- to-head Phase III trial conducted to date in
second-line non-small cell lung cancer, Alimta demonstrated the
following results relative to Taxotere, which was the current
standard of care in this setting at the time of the trial: --
Alimta's response rate (tumor shrinkage) of 9.1 percent. -- Alimta
had a median survival time of 8.3 months and a progression-free
survival time of 2.9 months. Progression-free survival represents
the number of months that a patient's disease remains in remission
following treatment without the disease getting worse. -- Patients
on Alimta experienced less Grade 3 or 4 neutropenia (a lowering of
the white blood cell count that can cause infections and fever,
thus requiring hospitalization), less neutropenia with fever, fewer
hospitalizations due to adverse events, less hair loss and less use
of supportive care. As with most chemotherapy agents, patients on
Alimta and Taxotere experienced low-blood cell counts. Patients on
Alimta did experience higher rates of Grade 3 or 4 Alanine
Transaminase (ALT), a laboratory measurement of liver function,
compared to Taxotere. Other Clinical Research: Alimta is currently
the focus of clinical research in the first-line treatment of
non-small cell lung cancer and cancers of the colon and breast. How
Alimta Is Administered: Patients receive a single 10-minute
infusion (500mg/m2) of Alimta every three weeks on an outpatient
basis. All patients who receive Alimta are given supplements of
folic acid and vitamin B12. Researchers discovered that this
nutritional supplementation significantly reduces the side effects
of Alimta without negatively impacting its effect on killing cancer
cells. For full prescribing information visit Alimta.com; Alimta(R)
(pemetrexed), Lilly Taxotere(R) (docetaxel, Sanofi-Aventis) (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: Gregory L. Clarke, +1-317-276-5222,
Mobile: +1-317-554-7119, or Christine Van Marter, +1-317-651-1473,
Mobile: +1-317-554-7923, both of Eli Lilly and Company
Copyright