Folotyn pralatrexate: Additional Phase IIb data

Additional data from the open-label, international Phase IIb PDX-012 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 Folotyn led to a median OS of 6.7 months vs. 7 months for Tarceva erlotinib. Median PFS was 3.4 months for Folotyn vs. 2.8 months for Tarceva. Folotyn also led to an ORR and disease control rate (DCR) of 2% and 36%, respectively, vs. 7% and 43% for Tarceva. Additionally, 56% and 28% of patients treated with Folotyn were alive at 6 months and 1 year, respectively, vs. 51% and 18% for Tarceva. Furthermore, Folotyn-treated patients with non-squamous cell carcinoma (n=107) had a 35% reduction in the risk of death and a 42% reduction in the risk of disease progression relative to Tarceva. Allos said the trial was not powered to detect statistical significance between treatment arms. Data were presented at the European Society for Medical Oncology meeting in Milan.

Allos previously reported that 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 Tarceva (see BioCentury, Aug. 2). 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. ...