Pomalidomide Treatment in Relapsed/Refractory Multiple Myeloma Patients—Real-World Data From Hungary

Abstract

Pomalidomide is a third generation immunomodulatory drug in the treatment of refractory and relapsed multiple myeloma patients. Our aim was to investigate the efficacy and safety of pomalidomide therapy in a real world setting. Eighty-six Hungarian patients were included, 45 of whom received pomalidomide ± an alkylating agent, while in 38 of them pomalidomide was combined with a proteasome inhibitor. 56 patients (65%) showed any response to the treatment with 18 complete or very good partial remissions and 38 partial remissions. At a median duration of follow-up of 18.6 months, the median progression-free survival (PFS) was 9.03 months, while the median overall survival (OS) was 16.53 months in the whole cohort. Patients with early stage disease (R-ISS 1 and 2) had better survival results than those with stage 3 myeloma (p = 0.002). Neither the number of prior treatment lines, nor lenalidomide refractoriness had a significant impact on PFS. PFS was found similar between the cohort of patients with impaired renal function and the cohort without kidney involvement. During the study, eight mortal infections and two fatal bleeding complications occurred, however, mild hematologic and gastrointestinal toxicities were identified as the most frequent adverse events. The results of our investigations confirm that pomalidomide is an effective treatment option for relapsed/refractory MM, besides, the safety profile is satisfactory in subjects with both normal and impaired renal function.

The real‐world use and efficacy of pomalidomide for relapsed and refractory multiple myeloma in the era of CD38 antibodies

“…We found that the outcomes of Pd, the ≥ PR rate of 35.8%, and the median TNT of 4.9 months were similar to those reported in previous studies [8][9][10][11][12][13][14][15]. Most notably, the clinical performance of Pd in our study was almost identical to that achieved in prospective clinical trials, which is typically not the case when prospective and real-world studies are compared [2,16,17,19].…”

“…Pomalidomide‐dexamethasone (Pd) has since been tested in triplet combinations with other antimyeloma agents and is currently approved for relapsed and refractory multiple myeloma in combination with bortezomib, daratumumab, isatuximab, or elotuzumab [3–7]. The outcomes of patients treated with Pd have been reported in several real‐world studies performed in smaller populations [8–15]. Recently, two novel antimyeloma drugs, the peptide‐conjugated alkylator melflufen in combination with dexamethasone, and the drug–antibody conjugate belantamab‐mafodotin both failed to prove superior to Pd in their respective randomized phase III trials [16, 17].…”

“…or elotuzumab [3][4][5][6][7]. The outcomes of patients treated with Pd have been reported in several real-world studies performed in smaller populations [8][9][10][11][12][13][14][15]. Recently, two novel antimyeloma drugs, the peptideconjugated alkylator melflufen in combination with dexamethasone, and the drug-antibody conjugate belantamab-mafodotin both failed to prove superior to Pd in their respective randomized phase III trials [16,17].…”

An elevated systemic inflammation index is related to an inferior response to pomalidomide and dexamethasone treatment in patients with relapsed and refractory multiple myeloma

“…The median PFS and OS were 10.0 and 14.0 months, respectively. In addition, a recent report based on real-world data from Hungary indicated a median PFS and OS of 9.0 and 16.5 months, respectively [ 27 ] The results were quite optimistic because the study group was heavily pretreated with a median of 4 prior therapy lines. However, almost all patients in this cohort received pomalidomide in combination with an alkylating agent or a proteasome inhibitor.…”