ALIMTA helped keep most common form of lung cancer at bay in elderly patients

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).