TAVALISSE delivered rapid, robust, and durable improvements in platelet counts
Robust improvements in platelet counts
Response rates achieved in the 24-week evaluation period (double-blind, placebo-controlled studies)
*Stable platelet response: achievement of a platelet count ≥50 x 10⁹/L on ≥4 of the 6 visits during weeks 14-24 without need for rescue treatment.
†Overall response: achievement of a platelet count ≥50 x 10⁹/L at least once during the first 3 months/12 weeks without need for rescue treatment.
Rapid improvements in platelet counts
TAVALISSE response summary—day 1 to 24 weeks11
‡Time to first response was a post hoc analysis.
- First platelet count measurement at week 2 and every 2 weeks thereafter
- A total of 102 patients exited the placebo-controlled trials early (at or after week 12) and entered the open-label extension study7
FIT-3 interim analysis: Durable benefit beyond 2 years11,§
A total of 61 of 123 patients discontinued from the open-label extension study early.
§Interim analysis, April 2017.
¶Duration of response analysis endpoint: the number of days from achieving a platelet count ≥50 x 109/L to reaching a platelet count <30 x 109/L at two consecutive visits. Patients were classified as losing response if platelet counts dropped below 30 x 109/L for two consecutive visits 28 days apart, or if rescue medication was used. Patients who discontinued prior to meeting the criteria for loss of response were censored on the last platelet count measurement date.
Bleeding events and use of rescue medication in FIT-1 and FIT-2
Rate of bleeding episodes—TAVALISSE patients had a lower incidence of bleeding episodes than placebo patients7,11
- In the placebo-controlled trials, the incidence of bleeding in patients who received TAVALISSE (regardless of responder status) was 29%, compared with 37% in patients who received placebo
Rescue medication use—TAVALISSE patients required less rescue medication than placebo patients7,11
- In the placebo-controlled trials, 30% of patients who received TAVALISSE (regardless of responder status) required rescue medication, compared with 45% of patients who received placebo
TAVALISSE demonstrated efficacy across patient subgroups compared to placebo
Treatment benefit favored TAVALISSE in the phase 3 clinical studies (FIT-1 + FIT-2)11
#Post hoc subgroup.