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ALIMTA® Extends Survival In Continuation Maintenance Setting For Specific Lung Cancer Patients

INDIANAPOLIS, Oct. 17, 2012 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that patients may receive ALIMTA ® (pemetrexed for injection) as a maintenance therapy following first-line ALIMTA plus cisplatin for locally advanced or metastatic nonsquamous non-small cell lung cancer (NS NSCLC). The FDA approved the label inclusion of Phase III data that demonstrated progression-free and overall survival advantages in the continuation maintenance setting for these patients.

Appropriate patients can now start with ALIMTA plus cisplatin and continue with ALIMTA in the maintenance setting in advanced or metastatic NS NSCLC. ALIMTA is indicated for the maintenance treatment of patients with locally advanced or metastatic NS NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ALIMTA is not indicated for patients with squamous-cell NSCLC. Myelosuppression is usually the dose-limiting toxicity with ALIMTA therapy.

"Continuation maintenance" involves continuing one of the same medicines prescribed in first-line treatment as maintenance therapy, in an effort to extend survival. It is the most recent addition to a new paradigm of maintenance treatment for advanced nonsquamous non-small cell lung cancer. Prior to the use of maintenance treatment, physicians typically treated a patient with four to six cycles of chemotherapy and then waited until the disease returned or worsened before resuming treatment.

"The approval provides patients and physicians with a new regimen that has demonstrated an improvement in overall survival. A survival benefit was previously established for ALIMTA for the first-line treatment of advanced nonsquamous non-small cell lung cancer in combination with cisplatin, and now as a single-agent for continuation maintenance treatment," said Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology. "This is the first study to show a survival advantage for continuation maintenance, and it reinforces the role of ALIMTA in treating patients with advanced nonsquamous NSCLC."

In October 2011, the European Commission granted approval for the use of ALIMTA as a single agent for continuation maintenance in patients with advanced NS NSCLC based on progression-free survival and preliminary overall survival. On September 21, 2012, theCommittee for Medicinal Products for Human Use (CHMP) in the European Union issued a positive opinion for a label update for ALIMTA in the continuation maintenance setting for certain patients with advanced nonsquamous non-small cell lung cancer after initial treatment with ALIMTA plus cisplatin.

The FDA and European Commission approvals were based on results from PARAMOUNT, a global, multicenter, double-blind Phase III trial, the final results of which were shared in an oral presentation at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Ill. on June 4, 2012. PARAMOUNT was the first study to evaluate the first-line use of ALIMTA plus cisplatin therapy followed immediately by the use of ALIMTA as a single-agent in the continuation maintenance setting.

A total of 939 patients with advanced nonsquamous NSCLC were enrolled in the study and received ALIMTA (500 mg/m 2 on day one of a 21-day cycle) in combination with cisplatin (75 mg/m 2) induction therapy. All patients received vitamin B 12, folic acid and dexamethasone. Patients whose disease had not progressed during the ALIMTA plus cisplatin induction and who had an ECOG performance status of 0-1 (n=539) were randomized two-to-one to receive ALIMTA maintenance (500 mg/m 2 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. Of the patients whose disease had not progressed during ALIMTA plus cisplatin induction therapy and who were randomized to receive maintenance therapy, 44% versus 42% achieved a complete or partial response to induction therapy and 53% versus 53% had stable disease after induction treatment in the ALIMTA and placebo arms, respectively.

Final results of the PARAMOUNT trial demonstrated a statistically significant 22 percent reduction in the risk of death (HR=0.78; 95% CI: 0.64–0.96; p=0.02) with ALIMTA, compared to placebo.  This reduction in the risk of death resulted in an improved median overall survival from the time patients were randomized of 13.9 months median for patients receiving ALIMTA, compared to 11.0 months median for patients on the placebo arm.

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