Efficacy of Isatuximab With Pomalidomide and Dexamethasone in Relapsed Myeloma: Results of a UK-Wide Real-World Dataset

Abstract

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. INTRODUCTIONThe multiple myeloma (MM) treatment landscape continues to evolve owing to the advent and approval of number of novel treatment combinations using distinct pharmacological classes such as immunomodulatory drugs (IMiDs), proteasome inhibitors (PIs), and anti-CD38 monoclonal antibodies (Mab), which

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

“…9 Real-world outcomes of IsaPomDex in a UK-wide study showed that efficacy outcomes are comparable to trial data. 10 ICARIA-MM trial outcomes by frailty employed the simplified frailty score and demonstrated that overall response rate (ORR) was statistically higher with IsaPomDex compared to PomDex, regardless of frailty status: frail (52.1% vs. 34.2%, p = 0.0476), non-frail (66.3% vs. 35.7%, p < 0.0001), but the difference in the ORR rate between frail and non-frail patients receiving IsaPomDex was not statistically significant (p = 0.3971). Median PFS was higher with IsaPomDex compared to PomDex regardless of frailty status, but the difference was only statistically significant for the non-frail subgroup comparison: frail (9 vs. 4.5 months, p = 0.4928), non-frail patients (12.7 vs. 7.4 months, p = 0.0004).…”

“…Alexandros Rampotas 1,2 Grant Vallance 1 Fotios Panitsas 3 Nanda Basker 4 Gina Sangha 5 Beena Salhan 6,7,8,9 Farheen Karim 9,10 Firas Al-Kaisi 11 Amy Gudger…”

Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma in real‐world: The retrospective IMAGE study

“…11 The study reported an overall response rate (ORR) of 66.4%, and an mPFS of 10.9 months. 11 Isa-Pd is also being investigated in the non-interventional, multinational, observational IONA-MM study. 12 Prior to its approval, Isa was available in France under two early access programs (EAPs)-a nominative temporary authorization for use (nATU) issued by French authorities for each patient upon a physician's request for access, then a cohort temporary authorization for use (cATU) intended to include a cohort of eligible patients according to a defined protocol.…”

“…Real‐world data are complementary to clinical trial data and are needed to determine factors in real‐world practice that may impact efficacy and safety. Real‐world use of Isa‐Pd has been reported in a UK‐wide, real‐world dataset, which utilized medical records of RRMM patients from 24 centers in the United Kingdom who started therapy between January 2020 and May 2021, and received ≥1 cycle of Isa‐Pd 11 . The study reported an overall response rate (ORR) of 66.4%, and an mPFS of 10.9 months 11 .…”

“…Real‐world use of Isa‐Pd has been reported in a UK‐wide, real‐world dataset, which utilized medical records of RRMM patients from 24 centers in the United Kingdom who started therapy between January 2020 and May 2021, and received ≥1 cycle of Isa‐Pd 11 . The study reported an overall response rate (ORR) of 66.4%, and an mPFS of 10.9 months 11 . Isa‐Pd is also being investigated in the non‐interventional, multinational, observational IONA‐MM study 12 …”