Clinical efficacy

In patients diagnosed with ITP, Tavlesse delivered robust improvements in platelet counts1-3

Stable response rates achieved in the 24-week evaluation period (double-blind, placebo-controlled trials)2, 3

Graph showing Tavlesse response rate in 24 weeks compared to placebo.

Adapted from Bussel J, et al. 20182, 3

Stable response (Primary endpoint)1, 6, *

  • Platelet counts ≥ 50,000 /μL during weeks 14-24 (at least 4 of 6 consecutive visits)
  • Median post-baseline platelet count: 95,000 /μL

Overall response rates achieved in the 24-week evaluation period (double-blind, placebo-controlled trial)1

Graph showing the overall response rates in the 24-week evaluation period of the treatment for chronic ITP patients.

Adapted from Bussel J, et al. 20182, 3

Overall response (post hoc endpoint)1, 6, ✝

  • At least one platelet count ≥ 50,000 /μL during weeks 0-12
  • Median post-baseline platelet count: 49,000 /μL
  • Median time to first response: 15 days in overall responders

Tavlesse overall response summary – day 1 to 24 weeks1

Median platelet counts by study visit - overall responders (pooled FIT + FIT2)

Graph and table showing the overall response summary from day 1 to week 24.

Adapted from Bussel J, et al. 2018

Study visits (weeks) 0 2 4 6 8 10 12 14 16 18 20 22 24

Overall responders
(n=43)

43

38

41

40

40

38

37

31

27

26

23

21

20

Non-responders
(n=58)

58

48

45

41

40

39

42

7

7

5

4

3

4

Placebo
(n=49)

49

43

41

35

31

33

32

11

6

3

4

2

3

First platelet count measurement at week 2 and every 2 weeks thereafter1

A total of 102 patients exited the placebo-controlled trials early (at or after week 12) and entered the open-label extension study2,3

Durable benefit

Tavlesse demonstrated durable increase in platelet levels for up to 3 years

Overall response observations from a 3-year post hoc interim analysis.4, *, †

Median platelet counts over time (Overall responders in the phase 3 clinical studies–FIT-1 + FIT-2 + FIT-3)

Graph showing  the increase in platelet levels in patients with chronic ITP that received Tavlesse during 3 years.

Adapted from Data on file, Grifols

  • Patients were evaluated every 2 weeks in the placebo-controlled trials (FIT-1 + FIT-2) and no less often than monthly for 18 months, and then bimonthly for up to 5 years in the open-label extension study (FIT-3)1, 5
  • A total of 102 patients exited the placebo-controlled trials early (at or after week 12) and entered the open-label extension study (FIT-3)2,3

Patient subgroups

Tavlesse demonstrated efficacy across patient subgroups (overall responder population) compared with placebo

A consistent treatment benefit vs placebo was seen across patient subgroups with Tavlesse in the FIT-1 and FIT-2 clinical trials2, 3, 5

Table showing patient subgroups with Tavlesse in the FIT-1 and FIT-2 clinical trials.

*Post hoc subgroup. CI: confidence interval; TPO-RA: thrombopoietin-receptor agonists. Overall responder population: Platelet count ≥50,000/μL at least once during first 3 months without need for rescue treatment.¹ Adapted from Bussel J, et al. 20181

Bleeding events and rescue medication

Treatment effect favoured Tavlesse with a trend towards fewer bleeding episodes and less rescue medication use compared with placebo

Bleeding events

Tavlesse patients had a trend towards a lower incidence of bleeding episodes compared to placebo patients2-4

In the placebo-controlled trials, the incidence of bleeding in patients who received Tavlesse (regardless of responder status) was 29%, compared with 37% in patients who received placebo2,3

Rescue medication

There was a trend towards Tavlesse patients requiring less rescue medication than placebo patients1

Graph showing the percentage of patients with chronic ITP that required rescue medication. The graph compares between the patients receiving Tavlesse compared to placebo.

Adapted from Bussel J, et al. 20181

  • Of patients treated with Tavlesse in the phase 3 clinical studies (FIT-1 + FIT-2 + FIT-3)4, *: 67% did not require rescue medication at any visit

In the placebo-controlled trials, 30% of patients who received Tavlesse (regardless of responder status) required rescue medication, compared with 45% of patients who received placebo2, 3

ITP: immune thrombocytopenia

References:

  1. Bussel J, Arnold DM, Grossbard E, et al. Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: results of two phase 3, randomized, placebo-controlled trials. Am J Hematol. 2018;93(7):921-930
  2. Tavlesse Summary of Product Characteristics. Great Britain. Grifols. Date of revision: January 2021. Available at https://www.medicines.org.uk/emc/product/11479 . Accessed on 14/2/2022.
  3. Tavlesse Summary of Product Characteristics. Northern Ireland. Grifols. Date of revision: August 2021. Available at https://www.emcmedicines.com/en-gb/northernireland/medicine?id=9c2f7cf0-129d-42a3-a61c-d729ae80e50c. Accessed on 14/2/2022
  4. Bussel J, Arnold DM, Boxer MA, et al. Long-term fostamatinib treatment of adults with immune thrombocytopenia during the phase 3 clinical trial program. Am J Hematol. 2019;94(5):546-553
  5. Boccia R, Boxer MA, Ghanima W, et al. Enhanced responses to fostamatinib as second-line therapy and in persistent immune thrombocytopenia (ITP) patients. Blood. 2019;134(suppl 1):1069. doi:10.1182/blood-2019-1264