Iopofosine I 131 improves survival in Waldenström’s macroglobulinemia
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The investigational targeted radiotherapy iopofosine I 131 improved survival for certain patients with Waldenström’s macroglobulinemia, according to the agent’s manufacturer.
The CLOVER WaM study assessed the efficacy and safety of iopofosine I 131 (Cellectar Biosciences) for patients with relapsed or refractory Waldenström’s macroglobulinemia who received at least two prior lines of therapy, including Bruton tyrosine kinase inhibitors.
The modified intent-to-treat population included 55 people (median age, 70 years; range, 50-88).
Patients had received a median four (range, 2-14) prior lines of therapy, with 27% being refractory to all available therapies — Bruton TKI, anti-CD20 antibodies and chemotherapy — and 40% being dual-class refractory (Bruton TKI and rituximab).
Major response rate (MRR) of at least 20% served as the primary endpoint. Secondary endpoints included disease control rate and duration of response.
Results showed an overall response rate of 80% and a MRR of 56.4% (95% CI, 0.42-0.67).
Researchers observed comparable ORRs across all clinically challenging disease subgroups, such as those with MYD88 wild-type disease (81%; n = 16) or P53-mutated disease (80%; n = 5). They also reported comparable ORRs among dual-class refractory (59%; n = 22) and triple-class refractory (53%; n = 15) patients.
Investigators reported a disease control rate of 98.2%. Median duration of response had not been reached; however, 78% of patients who achieved major response and 72% of those who achieved any response remained progression free at 18 months.
“Treatment options for relapsed or refractory [Waldenstrom’s macroglobulinemia] are limited, with a critical need for new therapies with novel mechanisms of action,” Sikander Ailawadhi, MD, professor of medicine at Mayo Clinic and lead investigator of the CLOVER WaM study, said in a press release. “Only about 10% of patients receiving salvage therapy respond to that treatment and experience limited durability of less than 6 months in later lines of therapy.”
Ailawadhi described the CLOVER WaM results as “very compelling,” citing “impressive deep and durable responses.”
Iopofosine I 131 exhibited a toxicity profile consistent with previously reported safety data, according to the release. The most common treatment-emergent adverse events included thrombocytopenia, neutropenia and anemia.
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