Lilly Set to Unveil More Than 50 Studies At ASCO 2009

Indianapolis/PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) will unveil data from more than 50 studies at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Fla. from May 29 to June 2, 2009, with the majority of the presentations continuing to support Lilly's leadership in thoracic cancer research. The company will present the latest research findings on ALIMTA(R) (pemetrexed for injection), as well as GEMZAR(R) (gemcitabine HCl for injection), and enzastaurin, an investigational, oral, targeted therapy.

This year's ASCO also marks the first time Lilly will feature the newest molecules in its portfolio resulting from Lilly's recent acquisition of ImClone Systems.

"ASCO's theme of 'Personalizing Cancer Care' is one to which Lilly has subscribed for many years," said Richard Gaynor, M.D., Lilly vice president, cancer research and global oncology platform leader. "We are focused on delivering what we call 'tailored therapies' — an essential component of personalized medicine — to identify patients who are most likely to respond to therapy, and just as importantly, which patients will not.

"With ASCO studies focusing on non-small cell lung cancer, breast cancer, cervical cancer and biliary tract cancer, among others, Lilly will demonstrate its continued commitment to meeting the needs of patients across a broad oncology spectrum."

Studies of note for ALIMTA include:

• Abstract #CRA8000: Oral Presentation: May 31, 2009, 9:00 a.m.
  • Maintenance pemetrexed (Pem) plus best supportive care (BSC) versus placebo (Plac) plus BSC: A randomized phase III study in advanced non-small cell lung cancer
  • This study is being presented at the ASCO press briefing on May 30, 11:00 a.m.
  • Abstract #e17533: Publish Only: May 14, 2009, 6:00 p.m. The Importance of Histology When Evaluating the Cost-Effectiveness of Pemetrexed plus Cisplatin as First-line Therapy for Advanced Non-Small Cell Lung Cancer
  • Abstract #8045: Poster Presentation: May 30, 2009, 2:00 p.m. Efficacy of pemetrexed-cisplatin (PC) in East Asian patients (pts): Subgroup analysis of a phase III study comparing PC versus gemcitabine-cisplatin (GC) in first-line treatment of advanced non-small cell lung cancer
  • Abstract #8037: Poster Presentation: May 30, 2009, 2:00 p.m. Final results of a randomized phase II trial of pemetrexed (P) + carboplatin (Cb) plus or minus enzastaurin (E) versus docetaxel (D) + Cb as first-line treatment of patients (pts) with stage IIIB/IV non-small cell lung cancer

Studies of note for GEMZAR include:

• Abstract #CRA5507: Oral Presentation: May 31, 2009, 10:30 a.m.
• A phase III study comparing concurrent gemcitabine (Gem) plus cisplatin (Cis) and radiation followed by adjuvant Gem plus Cis versus concurrent Cis and radiation in patients with stage IIB to IVA carcinoma of the cervix
• This study is being presented at the ASCO press briefing on May 31, 8:30 a.m.
• Abstract #4503: Oral Presentation: June 1, 2009, 4:30 p.m.
• Gemcitabine with or without cisplatin in patients (pts) with advanced or metastatic biliary tract cancer (ABC): Results of a multicenter, randomized phase III trial (the UK ABC-02 trial)
• This study is included in the ASCO presscast on May 14, 12:00 p.m.

Important Safety Information for ALIMTA (pemetrexed for injection)

ALIMTA is approved by the FDA in combination with cisplatin (another chemotherapy drug) for the initial treatment of advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA is approved by the FDA as a single agent (used alone) for the treatment of patients with advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC, after prior chemotherapy. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA is a treatment for malignant pleural mesothelioma (MPM), which is a cancer that affects the inside lining of the chest cavity. ALIMTA is given with cisplatin, another anticancer medicine (chemotherapy), when surgery is not an option.

ALIMTA may not be appropriate for some patients. If you are allergic to ALIMTA, tell your doctor because you should not receive it. If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. ALIMTA may harm your unborn or nursing baby. Your physician may advise you to use effective contraception (birth control) to prevent pregnancy while you are being treated with ALIMTA.

If you have liver or kidney problems, be sure to tell your doctor. Your dose of ALIMTA may have to be changed, or ALIMTA may not be right for you. There is a risk of side effects associated with ALIMTA therapy. ALIMTA can suppress bone marrow function. It is very important to take folic acid and vitamin B12 prior to and during your treatment with ALIMTA to lower your chances of harmful side effects.

Your healthcare professional will prescribe a medicine called a corticosteroid, which lowers your chances of getting skin reactions with ALIMTA. Ask your healthcare professional before taking medicines called NSAIDs (nonsteroidal anti-inflammatory drugs used to treat pain or swelling). Tell your doctor if you are taking other medicines, including prescription and non-prescription medicines, vitamins, and herbal supplements.

The most common side effects of ALIMTA when given alone or in combination with cisplatin, another chemotherapy drug, are low blood cell counts (red blood cells, white blood cells, and platelets); tiredness; stomach upset, including nausea, vomiting, and diarrhea; mouth, throat, or lip sores; loss of appetite; rash; and constipation.

Call your healthcare professional right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection. These are not all of the side effects of ALIMTA. If you have any side effect that bothers you or that does not go away, be sure to talk with your healthcare professional.

You will have regular blood tests before and during your treatment with ALIMTA. Your doctor may adjust your dose of ALIMTA or delay your treatment based on the results of your blood test and on your general condition.

For more information about all of the side effects of ALIMTA, please talk with your healthcare team, see the Patient Prescribing Information and full Prescribing Information, visit www.ALIMTA.com, or call 1-800-545-5979.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Important Safety Information for GEMZAR (gemcitabine HCl for injection)

GEMZAR is indicated in combination with cisplatin (another type of chemotherapy) for the first-line treatment of patients with locally advanced (Stage IIIA or Stage IIIB) or metastatic (Stage IV or cancer that has spread) non-small cell lung cancer for whom surgery is not possible.

GEMZAR is indicated in combination with carboplatin (another type of chemotherapy) for the patient with ovarian cancer that has returned at least 6 months after the patient had finished platinum-based therapy.

GEMZAR is indicated as a single agent (given alone) as the first-line treatment for patients with locally advanced (Stage II or Stage III when surgery is not an option) or metastatic (Stage IV) adenocarcinoma of the pancreas. GEMZAR is also indicated for patients previously treated with 5-FU (another type of chemotherapy).

GEMZAR in combination with paclitaxel is approved by the FDA for the first-line treatment of patients with metastatic breast cancer after they have received another type of chemotherapy called an anthracycline, unless their medical condition did not allow them to receive an anthracycline.

GEMZAR may not be appropriate for some patients.

If you are allergic to GEMZAR, tell your doctor you should not receive it. GEMZAR can suppress bone marrow function. There have been rare reports of serious kidney or liver toxicity with GEMZAR treatment, sometimes fatal. Serious lung toxicity has also been reported, sometimes fatal. If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. GEMZAR may harm your unborn or nursing baby.

If you have had prior kidney or liver problems or impairment, please tell your healthcare professional. GEMZAR may not be right for you. GEMZAR has not been shown to work in children. Tell your doctor if you are taking other medicines, including prescription and non-prescription medicines, vitamins, or herbal supplements.

There is a risk of side effects associated with GEMZAR therapy. The most common side effects are low blood cell counts (red blood cells, white blood cells, and platelets); fever; infection; hair loss; tiredness; nausea, vomiting, constipation, and diarrhea; rash; shortness of breath; muscle aches; and numbness or tingling in your toes or fingers. These are not all of the side effects of GEMZAR. If you have any side effect that bothers you or that does not go away, be sure to talk with your healthcare professional. Call your healthcare professional right away if you have fever or chills. These symptoms could mean you have an infection.

You will have regular blood tests before and during your treatment with GEMZAR. Your doctor may adjust your dose of GEMZAR or delay your treatment based on the results of your blood test and on your general condition.

For more information about all of the side effects of GEMZAR, please talk with your healthcare team, see the full Prescribing Information, visit www.GEMZAR.com, or call 1-800-545-5979.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

SOURCE: Eli Lilly And Company

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