PROCLAIM Final Trial Results to be Presented at ASCO Annual Meeting

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May 28, 2015, 08:30 ET

INDIANAPOLIS, May 28, 2015 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced final results of the Phase III PROCLAIM trial that will also be discussed in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. PROCLAIM was a randomized, Phase III superiority study of patients with locally-advanced, nonsquamous non-small cell lung cancer (NSCLC), which evaluated Lilly's ALIMTA^® (pemetrexed for injection), in combination with cisplatin with concurrent radiation followed by maintenance ALIMTA in comparison with etoposide and cisplatin plus concurrent radiation, followed by consolidation chemotherapy of the oncologist's choice.

PROCLAIM was the largest study to evaluate the effect of pemetrexed/platinum plus radiation in this setting. Lilly announced in 2012 that the study enrollment was halted because an Independent Data Monitoring Committee projected that the experimental arm of the study would not meet its primary endpoint of superior overall survival. As no new safety issues were identified, all patients who received treatment with the pemetrexed regimen were allowed to continue their assigned therapy at the discretion of the investigator and were followed for survival with the final results now at ASCO.

"Despite the outcome of this trial, ALIMTA is approved in first-line, maintenance, and second-line therapy for people with advanced, nonsquamous non-small cell lung cancer," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "We remain committed to exploring other combinations to treat patients with non-small cell lung cancer, including studying ALIMTA with some of the new immuno-oncology therapies in development."

In the PROCLAIM trial, patients with nonsquamous NSCLC were treated in the first-line setting with pemetrexed plus cisplatin and concurrent thoracic radiation therapy (n=283) or etoposide plus cisplatin and concurrent radiation (n=272). Patients on the pemetrexed arm received subsequent treatment with additional doses of single-agent pemetrexed and patients on the etoposide arm received consolidated chemotherapy – either more etoposide-cisplatin or vinorelbine-cisplatin or paclitaxel-carboplatin – as selected by the treating oncologist.

Those treated on the pemetrexed arm achieved a median overall survival (OS) of 26.8 months as compared to 25 months for those treated on the etoposide arm (HR 0.98; 95% CI: 0.79, 1.20; p=0.831). Median progression-free survival (PFS) was 11.4 months on the pemetrexed arm versus 9.8 months on the etoposide arm (HR 0.86; 95% CI: 0.71, 1.04; p=0.130) and an overall response rate (ORR) of 35.9 percent on the pemetrexed arm and 33 percent on the etoposide arm. Grade 3/4 adverse events occurred in 64.0 percent of patients on the pemetrexed arm with 76.8 percent on the etoposide arm. Grade 3/4 neutropenia/granulocytopenia was lower on the pemetrexed-cisplatin arm compared to the etoposide-arm (24.4% vs. 44.5%; p<0.0001), as well as rates of pneumonitis/pulmonary infiltrates (1.8% vs. 2.6%) and esophagitis (15.5% vs. 20.6%).

About ALIMTA^®
In 2004, ALIMTA received consecutive approvals: it was the first agent to be approved in combination with cisplatin as a treatment for patients with malignant pleural mesothelioma, whose disease is unresectable or who are otherwise not candidates for curative surgery, and then as a single agent for the second-line treatment of patients with locally advanced or metastatic NSCLC after prior chemotherapy treatment.^{^[1]}

In 2008, ALIMTA, in combination with cisplatin, was approved as a first-line treatment for locally advanced or metastatic NSCLC for patients with nonsquamous histology. At the time of the first-line approval, the FDA also approved a change to the second-line indication. ALIMTA is now indicated as a single agent for the treatment of patients with locally advanced or metastatic, nonsquamous NSCLC after prior chemotherapy.

In 2009, ALIMTA was approved as a maintenance therapy for locally advanced or metastatic NSCLC, specifically for patients with a nonsquamous histology whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. In 2012, ALIMTA received further approval as "continuation" maintenance therapy following first-line ALIMTA plus cisplatin for locally advanced or metastatic nonsquamous NSCLC.

ALIMTA is not indicated for treatment of patients with squamous cell NSCLC. Myelosuppression is usually the dose-limiting toxicity with ALIMTA therapy.

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.

It is very important to take the following medications prior to and during your treatment with ALIMTA to lower your chances of harmful side effects:

You must take folic acid every day by mouth beginning 7 days before your first dose of ALIMTA. You must keep taking folic acid every day during the time you are being treated with ALIMTA, and every day for 21 days after you receive your last dose of ALIMTA.
Your doctor will give you vitamin B₁₂ injections while you are getting treatment with ALIMTA. You will get your first vitamin B₁₂ injection one week before your first dose of ALIMTA, and then about every 9 weeks during treatment.
Your doctor will prescribe a medicine called a "corticosteroid" which you must take the day before, the day of, and the day after each treatment with ALIMTA to reduce rash.

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°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.
Redness or sores in your mouth, throat, on your lips or in the tube that connects your throat and stomach (esophagus). You may get redness or sores in your mouth, throat, on your lips, or in your esophagus (stomatitis, pharyngitis, esophagitis) or you may feel pain or have difficulty when drinking or swallowing food. These symptoms may happen a few days after ALIMTA treatment. Talk with your doctor if you get any of these symptoms.
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 reactions usually appear between treatments with ALIMTA and usually go away before the next treatment. Skin reactions or rashes that include blistering or peeling may be severe and could lead to death. Call your doctor if you have any of these symptoms.

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 accompanying this booklet, 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.

PM_CON_ISI_All_17OCT2012

About Lilly Oncology
For more than fifty years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. To learn more about Lilly's commitment to people with cancer, please visit www.LillyOncology.com.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels. (P-LLY)

This press release contains forward-looking statements about the potential of ALIMTA^® (pemetrexed for injection) as a treatment of nonsquamous non-small cell lung cancer and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There can be no guarantee that future study results and patient experience will be consistent with the study findings to date. Among other things, there can also be no guarantee that ALIMTA will receive regulatory approval for any future combinations or that it will prove to be commercially successful for any additional indications. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see the company's latest Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements.

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^[1] NOTE: The second-line NSCLC indication was approved under 21 CFR 314.500 et seq (Subpart H – Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses) using a surrogate endpoint.

Refer to: Crystal Livers-Powers; [email protected]; (317) 476-4160 (Lilly)
Neil Hochman; [email protected]; (212) 453-2067 (TogoRun)

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SOURCE Eli Lilly and Company