Sovleplenib delivers durable responses and QoL improvements in primary ITP

Sovleplenib was associated with early and durable platelet responses in participants with primary immune thrombocytopenia (ITP) who had received at least 1 prior line of therapy in the phase 3 ESLIM-01 trial. Combined with the acceptable safety profile and quality-of-life (QoL) improvements, this agent may be a valuable treatment for this patient population.

The spleen tyrosine kinase inhibitor sovleplenib was assessed for efficacy and safety in the phase 3 ESLIM-01 trial (NCT05029635). Participants (n=188) with primary ITP, previously treated with at least 1 therapy, were randomised 2:1 to sovleplenib or placebo. After 24 weeks, Prof. Renchi Yang (Chinese Academy of Medical Sciences, China) and colleagues assessed the durable response rate, defined as platelet counts ≥50*10⁹ platelets/L on at least 4 out of 6 scheduled visits between weeks 14 and 24, not influenced by rescue therapy [1].

Participants treated with sovleplenib achieved a durable response in 48.4% of the cases, compared with none in the placebo arm (P<0.0001). The researchers reported a higher overall response rate (at least 1 platelet count ≥50*10⁹ platelets/L) in the sovleplenib arm during the study (70.6% vs 16.1%; P<0.0001).

In total, 25.4% (experimental arm) and 24.2% (control arm) experienced grade ≥ 3 treatment-emergent adverse events. Upper respiratory tract infection (28.6%), COVID-19 infection (23.8%), and increased blood lactate dehydrogenase (23.8%) were common events in the sovleplenib arm. Finally, Prof. Yang noted that physical functioning and fatigue had improved significantly in the sovleplenib arm.

In conclusion, the safety and efficacy results of the current phase 3 trial indicate that sovleplenib could be a potential treatment option for patients with primary ITP who have received at least 1 prior line of therapy.

1. Yang R, et al. Efficacy and safety of the SYK inhibitor sovleplenib (HMPL-523) in adult patients with primary immune thrombocytopenia in Chine (ESLIM-01): a randomized, double-blind, placebo-controlled phase 3 study. S316, EHA congress 2024, 13–16 June, Madrid, Spain.

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Posted on 12 August 2024