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Selinisol plus pomalidomide/dexamethasone for the treatment of R/R myeloma
Multiple clinical staff discussed the results of the Phase 1/1b STOMP trial (NCT02343042), which evaluated selinexor in combination with pomalidomide ) and dexamethasone (dexamethasone) in the treatment of relapsed/refractory multiple myeloma patients.
The trial evaluated three dosing regimens of selinesol: 40 mg once weekly (SPd-40), 60 mg once weekly (SPd-60), and 60/80 mg twice weekly (SPd-60/80). The dosage of pomalidomide is 2 mg, 3 mg, or 4 mg once daily.
Study results announced at the 2024 ASH Annual Meeting showed that the overall response rate (ORR) of patients in the SPd-40 cohort (n=16) was 43.8% (95% CI, 19.8%-70.1%), and the median progression-free survival (PFS) could not be assessed (NE; 95% CI, 8.3-NE). The ORR of SPd-60 (n=20) and SPd-60/80 (n=18) cohorts were 55.0% (95% CI, 31.5%-76.9%) and 38.9% (95% CI 17.3%-64.3%), respectively. The median progression-free survival in these groups was 9.1 months (95% CI, 5.7-NE) and 10.4 months (95% CI, 2.0-NE), respectively.
Regarding safety,The most common any-grade treatment-emergent adverse reactions (TEAEs) reported in the SPd-40 cohort included neutropenia (75.0%), anemia (31.%), and thrombocytopenia (25.0%). These rates were lower than those observed in the SPd-60 and SPd-60/80 BIW cohorts, in which 75.0% and 50.0% of patients, respectively, experienced grade 3 or higher neutropenia. Additionally, no grade 5 adverse events were reported in the SPd-40 cohort.
Althoughthe ORR was higher in the SPd-60 group, patients in the SPd-40 group experienced longer median progression-free survival. The SPd-40 regimen was also associated with a longer median treatment exposure (28.0 weeks vs 22.0 weeks) and a higher median relative dose intensity (91.3% vs 77.5%) compared with the SPd-60 regimen. These findings may explain why long-term disease outcomes improved in the SPd-40 cohort.
Reference materials:https://www.onclive.com/view/dr-baljevic-on-selinexor-plus-pomalidomide-dexamethasone-in-r-r-myeloma
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