Primary endpoint met in CLOVER-WaM trial of Iopofosine 131 in R/R WM

The ongoing CLOVER-WaM trial (NCT02952508) investigating iopofosine I 131 (I-131) for patients with relapsed/refractory (R/R) Waldenstrom’s macroglobulinemia (WM) following a median of four prior lines of therapy, including Bruton’s tyrosine kinase inhibitors, has met its primary endpoint, with a major response rate of 61% (95% confidence interval [CI], 44.50–75.80; two-sided p value < 0.0001]).¹

Topline efficacy data in evaluable patients (n = 41) at data cut-off were as follows¹:

• overall response rate of 75.6%
• stringent complete remission rate of 8%
• 100% of patients experienced disease control
• durable responses, with a median duration of response not reached
• progression-free survival rate of 76% at a median follow-up of 8 months

Outcomes exceeded real-world data, which only demonstrated a 4–12% major response rate and duration of response of 6 months in a less pretreated and less refractory patient population.¹

I-131 was well-tolerated, with a toxicity profile consistent with previously reported data; no treatment-related deaths were reported. Given the unmet need for novel therapies in patients who experience relapse after Bruton’s tyrosine kinase inhibitor therapy, these encouraging efficacy and safety results show that I-131 remains a promising option for this patient population.

I-131 previously received Fast Track designation from the U.S. Food and Drug Administration (FDA) for patients with WM following two or more prior lines of therapy, R/R multiple myeloma, and R/R diffuse large B-cell lymphoma; it has recently been granted Priority Medicines designation from the European Medicines Agency (EMA) for patients with WM having received two or more prior treatments.²

‘The International Waldenstrom's Macroglobulinemia Foundation (IWMF) and the Lymphoma Hub are working in collaboration for patients with Waldenstrom's macroglobulinemia. This initiative aims to increase awareness of Waldenstrom's macroglobulinemia among healthcare professionals, patients, caregivers, and the patient advocacy community.

This initiative is funded by Beigene and Cellectar Biosciences. All content is developed independently by SES in collaboration with an expert steering committee; funders are allowed no direct influence on the content of the hub.’