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Lung Cancer Drug Fails to Meet Primary Endpoint in Phase III Trial

Eli Lilly and Company, based in Indianapolis, Ind., announced on September 6 that the phase III POINTBREAK trial did not meet its primary endpoint of improved overall survival for patients with nonsquamous non–small-cell lung cancer (NSCLC) who were randomly assigned to receive a combination of Alimta (pemetrexed for injection) with bevacizumab (Avastin) and carboplatin induction followed by Alimta plus bevacizumab maintenance (the Alimta arm) compared with the combination of paclitaxel with bevacizumab and carboplatin followed by bevacizumab maintenance (the paclitaxel arm).

The results will be presented on September 7 at the Chicago Multidisciplinary Symposium in Thoracic Oncology.

Patients with previously untreated stage IIIB/IV nonsquamous NSCLC and a performance status of 0 to 1 (n = 939) were randomly assigned to receive Alimta (500 mg/m2) plus carboplatin (AUC 6) plus bevacizumab (15 mg/kg), along with dexamethasone and folic acid and vitamin B12 supplementation (n = 472) or paclitaxel (200 mg/m2) plus carboplatin (AUC 6) plus bevacizumab (15 mg/kg) with dexamethasone (n = 467). First-line treatments were conducted every 3weeks for up to four cycles. Patients whose disease did not progress following first-line treatment received maintenance therapy with Alimta plus bevacizumab (n = 292) in the Alimta arm, while those in the paclitaxel arm received bevacizumab as a single agent (n = 298).

Patients randomized to the Alimta arm achieved a median overall survival of 12.6 months versus 13.4 months for patients in the paclitaxel arm (hazard ratio [HR]: 1.00; P = 0.949). Secondary objectives included the overall response rate (34.1% for Alimta vs. 33.0% for paclitaxel) and the disease control rate (65.9% for Alimta vs. 69.8% for paclitaxel), which did not show a significant difference between the two treatment arms.

Toxicity profiles differed between regimens. Significantly more drug-related grade 3/4 anemia (14.5% versus 2.7%), thrombocytopenia (23.3% versus 5.6%), and fatigue (10.9% versus 5.0%) occurred in patients in the Alimta arm versus those in the paclitaxel arm. Significantly more grade 3/4 neutropenia (40.6% versus 25.8%), febrile neutropenia (4.1% versus 1.4%), sensory neuropathy (4.1% versus 0%), and grade 1/2 alopecia (36.8% versus 6.6%) were seen in patients treated with paclitaxel than in those treated with Alimta.

For more information, visit the Eli Lilly Web site.

Eli Lilly and Company

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