Ann: PTX-100 trial advances following successful Phase 1b, page-65

The announcement references a Phase 2 study of pembrolizumab (Keytruda) in the Treatment of Relapsed or Refractory Mature T-cell Lymphoma. That trial was halted early after an interim futility analysis. Trial results were published in 2019.

Patients in the Keytruda trial had received a median of two prior therapies. Two patients dropped out of the trial due to toxicities. Median progression free survival was 3.2 months and median duration of response was 2.9 months. However there were 4 complete responders, two of whom remained in remission for>15 months.

Results: Of 18 enrolled patients, 13 were evaluable for the primary endpoint. The trial was halted early after a preplanned interim futility analysis. The overall response rate was 33% (95% confidence interval [CI], 9%-55%); 4 patients achieved a complete response (27%; 95% CI, 5%-49%). The median PFS was 3.2 months (95% CI, 1.2-3.7 months), and the median overall survival was 10.6 months (95% CI, 3.2-100 months). The median duration of response was 2.9 months (95% CI, 0-10.1 months). Two of the 4 complete responders remain in remission > 15 months.