Alimta misses vs. Avastin in NSCLC Phase III

Eli Lilly and Co. (NYSE:LLY) said first-line treatment with Alimta pemetrexed plus carboplatin followed by Alimta as maintenance therapy missed the primary endpoint in the Phase III PRONOUNCE trial to treat advanced non-small cell lung cancer. Specifically, Alimta did not improve median progression-free survival (PFS) without grade four adverse events vs. first-line treatment with paclitaxel, carboplatin and Avastin bevacizumab followed by Avastin as maintenance therapy (3.91 vs. 2.86 months, p=0.176). The Alimta arm also missed the secondary endpoints of improving PFS (p=0.61), overall survival (p=0.615), overall response rate (ORR) and disease control rate (DCR) vs. the Avastin arm. The open-label, U.S. trial enrolled 361 patients with stage IIIb/IV non-squamous NSCLC. Data were presented at the American Society of Clinical Oncology meeting in Chicago.

Alimta is approved in the U.S. and EU for first- and second-line therapy of locally advanced or metastatic non-squamous NSCLC, as well as for maintenance therapy following platinum-based chemotherapy, and for malignant pleural mesothelioma (MPM). Lilly declined to comment on whether the PRONOUNCE data will affect the approved NSCLC indications for Alimta, an antifolate that inhibits thymidylate synthase, dihydrofolate reductase (DHFR) and glycinamide ribonucleotide formyltransferase (GARFT). ...