TABLE 4.
Summary of secondary efficacy data after treatment with tigilanol tiglate. The secondary efficacy objectives relate to CR at 28 days and the percent of dogs with no local recurrence of the target tumor by 84 days. The first group is for dogs receiving a single treatment either in phase 1 or phase 2, the second group is for the original phase 1 group after either 1 or 2 treatments
| Treatment group | Day 28 | Day 84 | ||
|---|---|---|---|---|
| No. dogs CR/total no. dogs | %CR (95% CI) | No. dogs CR/total no. dogs | %CR (95% CI) | |
| Single treatment with TT (phase 1 and 2) | 85/116 a | 73 (64‐81) | 77/82 c | 94 (85‐97) |
| Original phase 1 TT treated dogs (after 1 or 2 treatments) | 70/80 b | 88 (77‐93) | 62/67 b | 93 (82‐97) |
Abbreviations: CR, complete response; FNA, fine needle aspirate; MCT, mast cell tumor; TT, tigilanol tiglate.
Sixty‐two of the 81 dogs in phase 1 and 23 of the 35 dogs in phase 2 at 28 days post treatment (Figure S1). The TT treated dog that was CR at day 28 and reassigned to the Not CR category due to MCT being detected on FNA at Day 84 on request from the regulatory agency was reverted back to CR at Day 28 for this analysis on the assumption that local recurrence occurred after Day 28. Of the 18 phase 1 TT treated dogs that were not CR at day 28, we assumed for this analysis that, had they not been retreated, none would have been CR on day 84.
Efficacy outcomes for dogs treated in phase 1 that did not achieve CR and were retreated in phase 2; 62 of the 81 dogs in phase 1 and 8 out of the 18 phase 1 Not CR dogs retreated in phase 2; of 18 dogs treated in phase 2, 44% (8; 95% CI = 22‐69) were CR at Day 28 and 88% had no local recurrence at Day 84 (7; 95% CI = 35‐97) (see Figure S1 for further details).
55 out of 59 dogs in phase 1 and 22 out of 23 dogs in phase 2 at 84 days post treatment (see Figure S1 for further details).