Isatuximab regimen demonstrates PFS benefit in relapsed, refractory multiple myeloma
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Isatuximab plus pomalidomide and low-dose dexamethasone continued to show significant improvement in time to next treatment and PFS2 compared with pomalidomide and dexamethasone in relapsed or refractory multiple myeloma, according to updated results from the ICARIA-MM study.
The data, presented at the ASCO Annual Meeting, demonstrated a strong trend in OS benefit in the istuximab (Sarclisa, Sanofi-Aventis) regimen arm, with approximately 7-month improvement in median OS.
Based on results from the ICARIA-MM study and from the IKEMA study, istuximab was approved in combination with pomalidomide and dexamethasone and in combination with carfilzomib and dexamethasone, Paul G. Richardson, MD, clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, and R.J. Corman Professor of Medicine at Harvard Medical School, said during the presentation.
In the study, 154 patients received the isatuximab regimen and 153 received pomalidomide and dexamethasone. Patients had a median of three prior lines of therapy. Richardson presented results from the preplanned second interim analysis that assessed longer-term outcomes, such as time to next treatment, overall survival, time from randomization to disease progression on the first subsequent therapy or death (PFS2) and safety.
As of October 1, 2020 (median follow-up = 35.3 months), 27 patients (18%) who received the isatuximab regimen vs. 12 patients (8%) who received just pomalidomide and dexamethasone were still on treatment; 60% vs. 72% had proceeded to subsequent therapy.
Median PFS2 was 17.5 months with the triplet therapy vs. 12.9 months with the doublet therapy (HR = 0.76; 95% CI, 0.58–0.99) and median OS was 24.6 months vs 17.7 months (HR = 0.76; 95% CI, 0.58–1.01), according to the abstract.
“Not surprisingly, responses have continued to deepen with [the isatuximab regimen] after an additional 2 years of therapy — 63% with the triplet vs. just 33% in the doublet arm,” Richardson said.
Median time to next treatment was 15.5 months with the isatuximab regimen vs. 8.9 months with pomalidomide and dexamethasone alone (HR = 0.56; 95% CI, 0.42–0.74); 24% vs. 58% of patients with subsequent therapy received daratumumab. The results showed ORR in later treatment with daratumumab monotherapy was higher after the doublet therapy (38%) than the triplet therapy (14%), but was similar (32% vs 31%) with daratumumab combination therapy.
“Of interest is that daratumumab monotherapy following [the isatuximab regimen] clearly appears to be less effective than following [pomalidomide and dexamethasone] alone. But, very interestingly, no such difference was observed when daratumumab was given in combination, pointing to the rationale for salvage strategies that require additional agents to be added in this setting,” Richardson said.
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Richardson PG, et al. Abstract 8017. Presented at: ASCO Annual Meeting; June 4-8, 2021 (virtual meeting).
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