Folotyn pralatrexate: Phase IIb data
Top-line data from an open-label, international Phase IIb trial in patients with stage IIIb/IV NSCLC who had received 1 or 2 prior systemic treatments, including at least 1 prior platinum-based regimen, showed that IV Folotyn reduced the risk of death by 16% and 13% in the overall patient population (n=201) and the primary efficacy analysis population (n=166), respectively, compared to daily Tarceva erlotinib. Allos said the trial was not powered to detect statistical significance between treatment arms, but said that positive trends in OS were observed in favor of Folotyn in all predefined patient cohorts, except in patients with squamous cell carcinoma and in patients who received prior treatment with Alimta pemetrexed. In patients with non-squamous cell carcinoma (n=107) and in light smokers (n=37), Folotyn reduced the risk of death by 35% and 37%, respectively, vs. Tarceva. The most common grade 3/4 adverse event was mucositis.
The first 35 patients enrolled in the trial received 150 mg/day oral Tarceva or 230 mg/m 2 IV Folotyn on days 1 and 15 of a 28-day cycle. Following a protocol amendment in which the dose of Folotyn was reduced, 166 patients were enrolled to receive 190 mg/m 2 Folotyn or Tarceva. The primary efficacy analysis included the 166 patients enrolled subsequent to the protocol amendment. All patients received concurrent vitamin therapy of B12 and folic acid. ...