Infections in relapsed myeloma patients treated with isatuximab plus pomalidomide and dexamethasone during the COVID-19 pandemic: Initial results of a UK-wide real-world study

© 2022 The Authors. Published by Taylor & Francis. This is an open access article available under a Creative Commons licence. The published version can be accessed at the following link on the publisher’s website: https://doi.org/10.1080/16078454.2022.2082725Objectives There are no real-world data describing infection morbidity in relapsed/refractory myeloma (RRMM) patients treated with anti-CD38 isatuximab in combination with pomalidomide and dexamethasone (IsaPomDex). In this UK-wide retrospective study, we set out to evaluate infections experienced by routine care patients who received this novel therapy across 24 cancer centres during the COVID-19 pandemic. Methods The primary endpoint was infection morbidity (incidence, grading, hospitalization) as well as infection-related deaths. Secondary outcomes were clinical predictors of increased incidence of any grade (G2–5) and high grade (≥G3) infections. Results In a total cohort of 107 patients who received a median (IQR) of 4 cycles (2–8), 23.4% of patients experienced ≥1 any grade (G2–5) infections (total of 31 episodes) and 18.7% of patients experienced ≥1 high grade (≥G3) infections (total of 22 episodes). Median time (IQR) from start of therapy to first episode was 29 days (16–75). Six patients experienced COVID-19 infection, of whom 5 were not vaccinated and 1 was fully vaccinated. The cumulative duration of infection-related hospitalizations was 159 days. The multivariate (MVA) Poisson Regression analysis demonstrated that a higher co-morbidity burden with Charlson Co-morbidity Index (CCI) score ≥4 (incidence rate ratio (IRR) = 3, p = 0.012) and sub-optimal myeloma response less than a partial response (<PR) (p = 0.048) are independent predictors of ≥ G3 infections. Conclusion Our study described initial results of infection burden during IsaPomDex treatment. We recommend close monitoring particularly in elderly patients with co-morbidities, the effective use of an-infective prophylaxis, as well as optimal vaccination strategies, to limit infections

Efficacy of isatuximab with pomalidomide and dexamethasone in relapsed myeloma: Results of a UK-wide real-world dataset

This is an accepted manuscript of a paper due to be published by Lippincott, Williams & Wilkins in HemaSphere (in press). The accepted manuscript of the publication may differ from the final published versionReal-world data on the efficacy and tolerability of isatuximab with pomalidomide and dexamethasone (IsaPomDex) in relapsed/refractory myeloma (RRMM) patients have not been reported. In this UK-wide retrospective study, IsaPomDex outcomes were evaluated across 24 routine care cancer centres. 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 (≥PR), and adverse events (AEs). In a total cohort 107 patients, median follow up (IQR) was 12.1 months (10.1-18.6 months), median age (IQR) was 69 years (61-77). Median (IQR) Charlson Co-morbidity index (CCI) score was 3 (2- 4); 43% had e-GFR<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 categorised as ≥VGPR: 31.8%, PR: 34.6%, SD: 15.9%, PD: 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 vs. 65-74 13.2 vs. ≥75: 8.5 months, log-rank p=0.4157), by CCI score (<4: 10.2 months vs. ≥4: 13.2, log-rank p=0.6531), but inferior PFS was observed with renal impairment (≥60: 13.2 vs. <60: 7.9 months, 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

Frailty subgroup analysis of isatuximab with pomalidomide and dexamethasone in a UK-wide real-world cohort of relapsed myeloma patients

This is an accepted manuscript of an article published by Wiley on 31/01/2023, available online: https://doi.org/10.1111/bjh.18672 The accepted version of the publication may differ from the final published version.Published versio