Alimta pemetrexed: Phase III data

A placebo-controlled, international Phase III trial in 795 patients showed that Alimta plus cisplatin every 3 weeks missed the primary endpoint of significantly improving median OS vs. cisplatin alone (7.3 vs. 6.3 months, p=0.082). There was no significant difference between treatment groups in quality of life scores (p=0.2). Alimta plus cisplatin did show a significant survival advantage in 2 of 9 pre-planned subgroup analyses vs. cisplatin alone, including in 690 patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (8.4 vs. 6.7 months, p=0.026), and in 192 patients with oropharyngeal cancer (9.9 vs. 6.1 months, p=0.002). Data were presented at the European Society for Medical Oncology meeting in Milan. Based on the results, Eli Lilly said it no longer plans to submit regulatory applications to FDA or the European Medicines Agency (EMA) for Alimta for the indication. ...