NICE recommends isatuximab in combination with pomalidomide and dexamethasone for the treatment of RRMM

On October 15, 2020, the National Institute for Health and Care Excellence (NICE) recommended the use of isatuximab (Isa) in combination with pomalidomide (P) and dexamethasone (d), within the Cancer Drugs Fund, as a treatment option for patients with relapsed/refractory multiple myeloma (RRMM) who have already received three lines of therapy (including lenalidomide and a proteasome inhibitor) and who progressed after the last treatment.¹

The recommendation was based on data from the ICARIA-MM trial, evaluating efficacy and safety of Isa-Pd (n = 154) versus Pd (n = 153) alone. This open-label, randomized trial was designed to enrol patients with RRMM who had at least two lines of previous therapy, including lenalidomide and a proteasome inhibitor.² However, because of the proposal as a treatment option after three lines of therapy, the NICE recommendation was based on a subgroup analysis of patients (Isa-Pd, n = 52; Pd, n = 58) who had three previous lines of treatment.¹ After a median follow-up of 11.6 months, the authors observed¹:

• A trend for improved progression-free survival in the Isa-Pd group versus the Pd group (13.3 versus 7.8 months; HR, 0.598; 95% CI, 0.348─1.03; p = 0.0611).
• That median overall survival had not yet been reached for the Isa-Pd arm (HR for overall survival compared with Pd was 0.494; 95% CI, 0.24─1.02; p = 0.0502).

These results are promising, but the median follow-up is short and the sample size small. The trial is still ongoing, and when the final analysis and enough evidence become available, the process for exiting the Cancer Drugs Fund and the review of the NICE guidance will start.¹