Lilly Oncology Prepares for Strong Showing at ASCO 2006; Targets Breast Cancer and Other Tumors with 79 Studies: 11 breast cancer studies; 29 thoracic cancer studies; and 8 studies with developing targeted agent

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® (gemcitabine HCl)
    • Title: Expression profiles can predict chemotherapy response in breast cancer patients, #10008
    • Date: Sat., June 3, 4:45 pm
  • ALIMTA® (pemetrexed)
    • Title: Phase II Study of Alimta as first-line therapy for advanced breast cancer, #3077
    • Date: Sun., June 4, 2:00 pm
    • 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®

Product Description: Gemzar® (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® (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 US$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® (gemcitabine HCl), Lilly. Taxol® (paclitaxel), Bristol-Myers Squibb Updated: March, 2006

Facts About Alimta®

Product Description: Alimta® (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® (pemetrexed), Lilly

Taxotere® (docetaxel, Sanofi-Aventis)

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Last update: March 06, 2014. 08:41:31 pm.