BASINGSTOKE, England, June 5, 2011 /PRNewswire/ --

- Pivotal Phase III ALIMTA study met primary endpoint

Eli Lilly and Company Limited announced today that PARAMOUNT(1), Lilly Oncology's Phase III study evaluating ALIMTA(R) (pemetrexed for injection) in the continuation maintenance setting, met its primary endpoint of progression-free survival, or the time a patient is alive without their disease worsening, for patients with a specific type of lung cancer called advanced nonsquamous non-small cell lung cancer (NSCLC).

"Continuation maintenance" treatment is when one of the same medicines used in first-line treatment setting is continued as maintenance therapy in an effort to control the cancer.

Results from the study will be presented on Sunday, June 5 at 11:30 a.m. EDT during the Lung Cancer Oral Abstract Session (Abstract #CRA7510) at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Ill. Lilly will present overall survival results from PARAMOUNT at a medical meeting in the future.

PARAMOUNT is the second study to evaluate the use of pemetrexed as a maintenance therapy in patients with advanced nonsquamous NSCLC, and the first study to evaluate the use of continuation maintenance with pemetrexed(2) following first-line pemetrexed plus cisplatin therapy.

Results of this multicentre, double-blind trial demonstrated the median progression-free survival measured from randomization (after first-line treatment) was 3.9 months on the pemetrexed arm as compared to 2.6 months on the placebo arm with a hazard ratio of 0.64. Said another way, the study showed that pemetrexed continuation maintenance arm resulted in a 36 percent improvement of survival without disease worsening over the placebo arm. The maintenance disease control rate, or the percentage of patients achieving either a response or stable disease first measured at 6 weeks post-randomization was 71.8 percent (2.8%/69.0%) on the pemetrexed arm and 59.6 percent (0.6%/59.0%) on the placebo arm.

"PARAMOUNT demonstrated that a pemetrexed continuation maintenance regimen -- single-agent pemetrexed following pemetrexed plus cisplatin induction therapy -- can improve progression-free survival in patients with the most common form of lung cancer," said Allen S. Melemed, M.D., M.B.A., pemetrexed medical product development leader at Lilly Oncology. "This finding continues to validate the use of pemetrexed maintenance treatment for certain patients living with this devastating disease."

A total of 939 patients with advanced nonsquamous NSCLC were enrolled in the study and received pemetrexed (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 pemetrexed+cisplatin induction and had a performance status of 0-1 (n=439) were randomized to receive pemetrexed maintenance (500 mg/m2 on day one of a 21-day cycle) plus best supportive care (n=359) or placebo plus best supportive care (n=180) until disease progression. All patients received vitamin B12, folic acid and dexamethasone.

Overall, the most serious (grade 3/4) drug-related adverse events (AEs) were higher for those treated with pemetrexed continuation maintenance versus placebo (9.2% vs. 0.6% laboratory and 8.9% vs. 4.4% non-laboratory). The most commonly reported drug-related AEs observed on the pemetrexed arm versus placebo were anemia (4.2% vs. 0.6%), fatigue (4.5% vs. 0.6%), and neutropenia (3.6% vs. 0%). There was one potentially drug-related death on each arm. Discontinuations due to AEs were 5.3 percent with pemetrexed and 3.3 percent with placebo.

The study was conducted in patients with advanced nonsquamous NSCLC because past studies have shown that advanced NSCLC patients with a nonsquamous histology (those with adenocarcinoma, large cell carcinoma, or other subtypes) experienced improved efficacy over the relative comparator arm in the trial (an increase in progression-free survival, as well as overall survival), when treated with an pemetrexed regimen.(2,3) Patients with advanced NSCLC with squamous cell histology were not included in the PARAMOUNT study as pemetrexed has not shown to be effective in this patient population relative to the comparators in these previous trials.

NOTES TO EDITORS:

About Non-Small Cell Lung Cancer (NSCLC)

Globally, lung cancer is the most common form of cancer and the biggest killer, causing over 1 million cancer deaths annually.(4) About 85 - 90 percent of all lung cancers are NSCLC.(5) 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(6), as well histologies classified as "other."

About Lilly Oncology

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.

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 organisations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.

UKALM00327 June 2011

References

(1) Paz-Ares L. G 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). ASCO Abstract (CRA7510), Chicago, USA June 3-7 2011

(2) Ciuleanu T, et al. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. The Lancet, Vol. 374 No. 9699 pp 1432-1440, October 24, 2009.

(3) Scagliotti G, Purvish P, et al. Phase III study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Abstract PRS-3, 12th World Conference on Lung Cancer (WCLC) 2007. Journal of Thoracic Oncology, Vol 2 No 8, Supplement 4, Page S306, August 2007.

(4) 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, (April 20, 2011).

(5) 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, (April 20, 2011).

(6) American Cancer Society, "What Is Non-Small Cell Lung Cancer?," October 20, 2009, American Cancer Society, http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Non-Small_Cell_Lung_Cancer.asp?rnav=cri, (April 20, 2011).

The licensed indications of Alimta are contained in the full Summary of Product Characteristics that is available here: http://www.medicines.org.uk/EMC/medicine/15513/SPC/Alimta+100mg+500mg+powder+for+concentrate+for+solution+for+infusion/

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SOURCE Eli Lilly and Company