Phase 3 Trial Update of Alimta for Nonsquamous Non-Small Cell Lung Cancer

Eli Lilly and Company announced today that the Phase 3 POINTBREAK trial did not meet its primary endpoint of improved overall survival for patients with nonsquamous non-small cell lung cancer (NSCLC) who were randomized to receive a combination of Alimta (pemetrexed for injection) with bevacizumab (Avastin; Genentech) and carboplatin induction followed by Alimta plus bevacizumab maintenance–the Alimta arm–compared to the combination of paclitaxel (Taxol; Bristol-Myers Squibb) with bevacizumab and carboplatin followed by bevacizumab maintenance–the paclitaxel arm. The study did meet one of its secondary endpoints of improved progression-free survival for the Alimta arm.

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

Overall survival for patients randomized to the Alimta arm achieved a median overall survival of 12.6 months vs. 13.4 months for patients on the paclitaxel arm (HR 1; P=0.949), a result that demonstrated no statistical difference. POINTBREAK showed a statistically significant improvement in progression-free survival (6 months vs. 5.6 months [HR 0.83; P=0.012]) in the Alimta arm. Secondary objectives also included overall response rate (34.1% vs. 33%) and disease control rate (65.9% vs. 69.8%), which did not show a difference between the two arms.                                                    

A pre-specified non-comparative survival analysis for a subgroup of patients treated with maintenance therapy showed a median survival of 17.7 months for the Alimta arm and 15.7 months for the paclitaxel arm and progression-free survival of 8.6 months and 6.9 months.

Alimta is a folate analog metabolic inhibitor indicated for locally advanced or metastatic nonsquamous non-small cell lung cancer (initial treatment in combination with cisplatin, maintenance treatment of patients whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, or after prior chemotherapy as a single-agent).  Alimta is also indicated for mesothelioma (in combination with cisplatin).

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