The Phase III registrational trial of orelabrutinib for the treatment of ITP is ongoing in China. Overall, 36.4% of patients met the primary endpoint, and 40% at the 50mg arm reached the primary endpoint. Among 12 patients with primary endpoint response, 83.3% achieved adurable response.Among the 22 patients with previous responses to glucocorticoid (GC) or intravenous immunoglobulin (IVIG), 75.0% at the 50mg arm met the primary endpoint.
Cumulative number of New Gd+ T1 Lesion from Week 4 to Week 24 | Placebo / Orela 50mg QD (N=27) | Orela 50mg QD (N=30) | Orela 50mg BID (N=29) | Orela 80mg QD (N=29) |
Adjusted mean cumulative number (95% CI) of lesions from W4 to W24 | 6.45 (3.62, 11.52) | 2.10 (0.62, 7.11) | 1.08 (0.30, 3.81) | 0.50 (0.09, 2.74) |
Percent reduction | 67.4 (-22.0, 91.3) | 83.3 (33.2, 95.8) | 92.3 (56.5, 98.6) | |
P-value | 0.0958 | 0.0114 | 0.0037 |