News Release

INDIANAPOLIS, Sept. 26, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that a new subgroup analysis of data from the pivotal Phase III PARAMOUNT study showed that continuation maintenance therapy with ALIMTA^® (pemetrexed for injection) also reduces the risk of disease progression in patients aged 70 years or older with advanced nonsquamous non-small cell lung cancer (NSCLC), the most common type of lung cancer.

Results from the new analysis were presented during the Lung Cancer — Metastatic Poster Session (Abstract #9072) at the 2011 European Multidisciplinary Cancer Congress (formerly known as the ECCO-ESMO Cancer Congress) in Stockholm, Sweden.

PARAMOUNT is the first study to evaluate the use of continuation maintenance therapy with ALIMTA following first-line ALIMTA plus cisplatin therapy. A total of 939 patients with advanced nonsquamous NSCLC were enrolled in the study; 539 did not progress during the induction phase and entered the maintenance phase of the trial. Of those, 92 patients were elderly.

The new analysis compared ALIMTA to placebo in elderly patients aged greater than or equal to 70 years (n=92). In the group of elderly patients, ALIMTA reduced the risk of disease progression by 65 percent (hazard ratio, 0.35; 95% CI: 0.20—0.63), based on a median progression-free survival of 6.4 months on the ALIMTA arm compared with 3.0 months on the placebo arm. In the group of patients less than 70 years of age, ALIMTA reduced the risk of disease progression by 31 percent (hazard ratio, 0.69, 95% CI: 0.54—0.90), with a progression-free survival of 4.0 months for ALIMTA and 2.8 months for placebo.

"Lung cancer can be challenging to treat in patients over 70 years of age because they often have comorbidities and may be less tolerant of anti-cancer therapies," said Cesare Gridelli, M.D., a clinical trial investigator for the PARAMOUNT study and physician with S. Giuseppe Moscati Hospital in Avellino, Italy. "In fact, some patients over the age of 70 may simply be offered supportive care alone. These results show that an ALIMTA maintenance regimen could provide benefit to certain elderly patients."

The study included patients with advanced nonsquamous NSCLC who received ALIMTA (500 mg/m2 on day one of a 21-day cycle) in combination with cisplatin (75 mg/m2) induction therapy. Patients whose disease had not progressed during the ALIMTA plus cisplatin induction and had a performance status of 0-1 were randomized to receive ALIMTA maintenance (500 mg/m2 on day one of a 21-day cycle) plus best supportive care or placebo plus best supportive care until disease progression.

Overall, the most serious (laboratory grade 3/4) drug-related adverse events were higher for elderly patients treated with ALIMTA continuation maintenance compared with patients less than 70 years of age (21% vs. 7%). These adverse events were primarily hematological (anemia and neutropenia). Elderly patients in the study tended to have a poorer performance status than younger patients (PS 0: 20% vs. 34%, respectively; PS 1: 79% vs. 66%, respectively), and the older group received more cycles of ALIMTA therapy (5.5 vs. 4.8 in the younger group).

Overall results of PARAMOUNT, which met its primary endpoint of progression-free survival, were presented in June 2011 at the American Society of Clinical Oncology (ASCO) Annual Meeting(1).

Notes to Editor

About Non-Small Cell Lung Cancer (NSCLC)

Globally, lung cancer is the most common form of cancer and the biggest killer, causing 1.3 million cancer deaths annually(2).  About 85 — 90 percent of all lung cancers are NSCLC(3).  The liver, bones and brain are potential targets if the cancerous cells enter the bloodstream.

NSCLC comprises a group of histologies or tumor types differentiated by cellular structure. Nonsquamous histology includes adenocarcinoma and large cell carcinoma, which account for more than half of all NSCLC diagnoses(4), as well histologies classified as "other."

About Lilly Oncology, a Division of Eli Lilly and Company  

For more than four decades, Lilly Oncology, a division of Eli Lilly and Company, has been dedicated to delivering innovative solutions that improve the care of people living with cancer.  Because no two cancer patients are alike, Lilly Oncology is committed to developing novel treatment approaches.  To learn more about Lilly's commitment to cancer, please visit www.LillyOncology.com.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of 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

ALIMTA^® (pemetrexed for injection), Lilly

Important Safety Information for ALIMTA® (pemetrexed for injection)

What is the most important information that I should know about ALIMTA?

ALIMTA can suppress bone marrow function, which may cause low blood cell counts.

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 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.

Your doctor will prescribe a medicine called a "corticosteroid" to take for 3 days during each treatment with ALIMTA. Corticosteroids lower your chances for getting skin reactions with ALIMTA.

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.

• You must take folic acid every day for at least 5 days out of the 7 days before your first dose of ALIMTA. You must keep taking folic acid every day during the time you are getting treatment with ALIMTA, and for 21 days after your last treatment.

• Your doctor will give you vitamin B12 injections while you are getting treatment with ALIMTA. You will get your first vitamin B12 injection during the week before your first dose of ALIMTA, and then about every 9 weeks during treatment.

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.

What should I tell my doctor before receiving ALIMTA?

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.

Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements. ALIMTA and other medicines may affect each other, causing serious side effects. Especially, tell your doctor if you are taking medicines called "nonsteroidal anti-inflammatory drugs" (NSAIDs) for pain or swelling.

What are the possible side effects of ALIMTA?

Most patients taking ALIMTA will have side effects. Sometimes it is not always possible to tell whether ALIMTA, another medicine, or the cancer itself is causing these side effects.

Call your doctor right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection, which may be severe and could lead to death.

The most common side effects of ALIMTA when given alone or in combination with cisplatin are:

• Stomach upset, including nausea, vomiting, diarrhea, or constipation. You can obtain medicines to help control some of these symptoms. Call your doctor if you get any of these symptoms.

• Low blood cell counts:
• Low red blood cells. Low red blood cells may make you feel tired, get tired easily, appear pale, and become short of breath.
• Low white blood cells. Low white blood cells may give you a greater chance for infection. If you have a fever (temperature above 100.4 degrees F) or other signs of infection, call your doctor right away.
• Low platelets. Low platelets give you a greater chance for bleeding. Your doctor will do blood tests to check your blood counts before and during treatment with ALIMTA.
• Tiredness. You may feel tired or weak for a few days after your ALIMTA treatments. If you have severe weakness or tiredness, call your doctor.
• Mouth, throat, or lip sores (stomatitis, pharyngitis). You may get redness or sores in your mouth, throat, or on your lips. These symptoms may happen a few days after ALIMTA treatment. Talk with your doctor about proper mouth and throat care.
• Loss of appetite. You may lose your appetite and lose weight during your treatment. Talk to your doctor if this is a problem for you.
• Rash. You may get a rash or itching during treatment. These usually appear between treatments with ALIMTA and usually go away before the next treatment. Rarely, these reactions may be severe (can lead to Stevens-Johnson syndrome or toxic epidermal necrolysis) and could lead to death. Call your doctor if you get a severe rash, itching, or blistering.

Talk with your doctor, nurse, or pharmacist about any side effect that bothers you or that doesn't go away.

These are not all the side effects of ALIMTA. For more information, ask your doctor, nurse, or pharmacist.

How is ALIMTA given?

ALIMTA is slowly infused (injected) into a vein. The injection or infusion will last about 10 minutes. You will usually receive ALIMTA once every 21 days (3 weeks).

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.

This press release contains forward-looking statements about the potential of ALIMTA for the treatment of non-small cell lung cancer 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, commercialization, and regulatory review.  There is no guarantee that the products will receive additional regulatory approvals. There is also no guarantee that the product will continue 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.

(1)  Paz-Ares LG, De Marinis F, et.al. PARAMOUNT: Phase III study of maintenance pemetrexed (pem) plus best supportive care (BSC) versus placebo plus BSC immediately following induction treatment with pem plus cisplatin for advanced nonsquamous non-small cell lung cancer (NSCLC). J Clin Oncol 29: 2011 (suppl; abstr CRA7510).

(2)  World Health Organization, Gender in Lung Cancer and Smoking Research, Department of Gender, Women and Health, 2003, http://www.who.int/gender/documents/en/lungcancerlow.pdf, (July 25, 2011).

(3)  American Cancer Society, "What Is Non-Small Cell Lung Cancer?," December 16, 2010, American Cancer Society, http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/DetailedGuide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer, (July 25, 2011).

(4)  American Cancer Society, "What Is Non-Small Cell Lung Cancer?," December 16, 2010, American Cancer Society, http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/DetailedGuide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer, (July 25, 2011).

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SOURCE Eli Lilly and Company