Sovleplenib may offer QOL improvements for patients with primary immune thrombocytopenia.
Sovleplenib was associated with early and durable platelet responses in participants with primary immune thrombocytopenia (ITP). Together with the acceptable safety profile and quality of life (QoL) improvements, this agent may be a valuable treatment for patients with primary ITP who have received at least one prior therapy.
The spleen tyrosine kinase inhibitor sovleplenib was assessed for efficacy and safety in the phase 3 ESLIM-01 trial (NCT05029635). Participants with primary ITP, previously treated with at least one therapy, were randomly assigned 2:1 to sovleplenib or placebo (n=188). After 24 weeks, Dr. Renchi Yang, MD, from the Chinese Academy of Medical Sciences, in China, and colleagues primarily assessed the durable response rate, defined as platelet counts under or equal to 50*109 platelets/L on at least four out of six scheduled visits between weeks 14 and 24, not influenced by rescue therapy.
Participants treated with sovleplenib achieved a durable response in 48.4% of the cases, compared to 0% in the placebo arm (P<0.0001). The researchers also reported a higher overall response rate (at least one 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 under or equal to 3 treatment-emergent AEs. 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, Dr. 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 one prior line of therapy.
Medical writing support was provided by Robert van den Heuvel.
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