Key clinical point: The addition of lenalidomide (LEN) to epoetin (EPO) alfa offers a superior probability of clinically meaningful and highly durable erythroid response vs. LEN alone in patients with lower-risk, non-del (5q) myelodysplastic syndromes (MDS) who have anemia that is refractory to recombinant erythropoietin.
Major finding: After 4 cycles of treatment, major erythroid response was significantly higher with the combination of LEN and erythropoietin vs. LEN alone (28.3% vs. 11.5%; P = .004). Responses to the combined treatment were highly durable with a median major erythroid response duration of 23.8 months in the combined therapy cohort vs. 13 months in the LEN cohort.
Study details: In this phase 3 US intergroup trial , 195 patients with MDS and anemia were randomly assigned to receive LEN and EPO alfa (n = 99) or LEN alone (n = 96) following stratification by serum erythropoietin concentration and prior erythropoietin treatment.
Disclosures: The study was supported by the ECOG-ACRIN Cancer Research Group Study, the National Cancer Institute (NCI) of the National Institutes of Health, and NCI. The authors reported ties with various pharmaceutical companies.
Source: List AF et al. J Clin Oncol. 2021 Jan 13. doi: 10.1200/JCO.20.01691 .