Treatment of multiple myeloma (MM) with generic pomalidomide plus low-dose dexamethasone (LoDex) is a valid treatment option for Chinese patients with relapsed/refractory disease (RRMM), according to a poster from the European Society for Medical Oncology Congress 2021.
This treatment regimen demonstrated encouraging efficacy in two previous studies of patients with RRMM, but those studies were conducted in Europe, North America, and Australia. The efficacy of pomalidomide had not been verified in a population of Chinese patients.
The generic pomalidomide was first produced by CTTQ Group. Once bioequivalence with original pomalidomide was confirmed, the researchers designed this study.
In this multicenter, single-arm, open-label phase 2 study, 74 patients received generic pomalidomide 4 mg per day plus LoDEX 40 mg on days one, eight, 15, and 22. Patients enrolled were heavily pretreated with a median of three prior lines of therapy.
With a median follow-up of 32.95 months, the overall response rate (ORR) was 37.8% with a median response duration of 8.8 months. The ORR was consistent across all patient subgroups stratified by sex, age, prior transplantation, refractory to lenalidomide, renal function, and cytogenetic risk.
Complete response occurred in 4.05% of patients and very good partial response in 6.76%.
Median progression-free survival was 5.7 months and median overall survival was 24.3 months.
Grade three or worse treatment-emergent adverse events occurred in 89.2% of patients. The most common of these were neutropenia, leukopenia, anemia, and thrombocytopenia. Serious adverse events occurred in 52.7% of patients and death occurred in 8.1%.