Efficacy of isatuximab with pomalidomide and dexamethasone in relapsed myeloma: results of a UK-wide real-world dataset.
Djebbari, Faouzi Rampotas, Alexandros Vallance, Grant Panitsas, Fotios Basker, Nanda Sangha, Gina Salhan, Beena Karim, Farheen Al-Kaisi, Firas Gudger, Amy
Djebbari, Faouzi
Rampotas, Alexandros
Vallance, Grant
Panitsas, Fotios
Basker, Nanda
Sangha, Gina
Salhan, Beena
Karim, Farheen
Al-Kaisi, Firas
Gudger, Amy
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2022-05-26
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Real-world data on the efficacy and tolerability of isatuximab with pomalidomide and dexamethasone (IsaPomDex) in relapsed/refractory myeloma patients have not been reported. In this UK-wide retrospective study, IsaPomDex outcomes were evaluated across 24 routine care cancer centers. The primary endpoint was overall response rate (ORR). Secondary endpoints included progression-free survival (PFS), duration of response (DOR) for patients who achieved an objective response (≥partial response [PR]), and adverse events (AEs). In a total cohort 107 patients, median follow up (interquartile range [IQR]) was 12.1 months (10.1-18.6 mo), median age (IQR) was 69 years (61-77). Median (IQR) Charlson Comorbidity Index (CCI) score was 3 (2-4); 43% had eGFR <60 mL/min. Median (IQR) number of prior therapies was 3 (3-3). Median (IQR) number of IsaPomDex cycles administered was 7 (3-13). ORR was 66.4%, with responses categorized as ≥ very good partial response: 31.8%, PR: 34.6%, stable disease: 15.9%, progressive disease: 15%, and unknown 2.8%. Median PFS was 10.9 months. Median DOR was 10.3 months. There was no statistical difference in median PFS by age (<65: 10.2 versus 65-74 13.2 versus ≥75: 8.5 mo, log-rank P = 0.4157), by CCI score (<4: 10.2 mo versus ≥4: 13.2, log-rank P = 0.6531), but inferior PFS was observed with renal impairment (≥60: 13.2 versus <60: 7.9 mo, log-rank P = 0.0408). Median OS was 18.8 months. After a median of 4 cycles, any grade AEs were experienced by 87.9% of patients. The most common ≥G3 AEs were neutropenia (45.8%), infections (18.7%), and thrombocytopenia (14%). Our UK-wide IsaPomDex study demonstrated encouraging efficacy outcomes in the real world, comparable to ICARIA-MM trial.
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Djebbari F, Rampotas A, Vallance G, Panitsas F, Basker N, Sangha G, Salhan B, Karim F, Al-Kaisi F, Gudger A, Ngu L, Poynton M, Lam HPJ, Morgan L, Yang L, Young J, Walker M, Tsagkaraki I, Anderson L, Chauhan SR, Maddams R, Soutar R, Triantafillou M, Prideaux S, Obeidalla A, Bygrave C, Basu S, Ramasamy K. Efficacy of Isatuximab With Pomalidomide and Dexamethasone in Relapsed Myeloma: Results of a UK-Wide Real-World Dataset. Hemasphere. 2022 May 26;6(6):e738. doi: 10.1097/HS9.0000000000000738
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