Page 153 - Haematologica Vol. 109 - July 2024

ARTICLE - Sovleplenib Syk inhibitor in R/R B-cell tumors
mentary Appendix).
Patients who received ≥1 dose of sovleplenib were included in the safety set (SS). The efficacy-evaluable analysis set (EEAS) included all patients in the SS who had ≥1 valid postbaseline tumor evaluation. Objective response rate (ORR) and 95% confidence interval (CI) were calculated using the Clopper-Pearson method. Time to event was es- timated using the Kaplan-Meier method. Analyses of time to response (TTR) and duration of response (DOR) were based on the EEAS, and analyses of time to progression (TTP) and progression-free survival (PFS) were based on the SS. Post hoc analyses of investigator-assessed tumor response were performed in CLL/SLL or FL according to prior treatment status.
The pharmacokinetic analysis set included patients who received ≥1 dose of sovleplenib with concentration data
Y. Song et al. available. Pharmacokinetic parameters were analyzed with
a non-compartmental model using Phoenix WinNonlin software (v8.1). Pharmacokinetic and biomarker analyses were summarized using descriptive statistics.
Results
Patients and demographics
Between December 15, 2016, and September 3, 2020, 166 patients were screened at 18 centers across China; 134 were enrolled and received sovleplenib (Figure 1).
Dose escalation
During dose escalation, 27 patients were enrolled (Figure 1). Among them, 23 (85.1%) were classified as Ann Arbor
Figure 1. Patient disposition. The safety set (SS) includes all patients who have taken at least 1 dose of study drug. The effica- cy-evaluable analysis set (EEAS) includes all patients in the SS who have at least 1 valid postbaseline tumor evaluation. b.i.d.: twice daily; DLT: dose-limiting toxicity; q.d.: once daily.
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