Among the patients evaluable for efficacy in PROPEL, three analysis sets were identified to investigate the overall response rate (ORR), complete remission (CR), PFS, and duration of response (DOR) based on the number of prior line of treatment, including 1) patients (n = 23) who had received one prior systemic therapy, 2) patients (n = 29) who had received two prior systemic therapies, and 3) patients (n = 57) who had received at least three prior systemic therapies.
The von Hoff analysis (10 (link),15 (link),16 (link)), compares the PFS on the study treatment to the PFS on the line of therapy before. The analysis is predicated on the idea that successive lines of therapy almost never produce a benefit greater than the lines of treatment before. Thus, the statistics of the analysis are defined as PFS on the experimental drug / PFS for the line of therapy just before, with a ratio greater than 1.3 being considered statistically significant, where the hypothesis would miss up to 15% for PFS ratio more than 1.3. The Von Hoff analysis was performed on the subset of patients with refractory disease (n = 68) that responded to pralatrexate treatment (n = 16).
The von Hoff analysis (10 (link),15 (link),16 (link)), compares the PFS on the study treatment to the PFS on the line of therapy before. The analysis is predicated on the idea that successive lines of therapy almost never produce a benefit greater than the lines of treatment before. Thus, the statistics of the analysis are defined as PFS on the experimental drug / PFS for the line of therapy just before, with a ratio greater than 1.3 being considered statistically significant, where the hypothesis would miss up to 15% for PFS ratio more than 1.3. The Von Hoff analysis was performed on the subset of patients with refractory disease (n = 68) that responded to pralatrexate treatment (n = 16).
