Monday, Cellectar Biosciences Inc CLRB announced that iopofosine I 131 combined with external beam radiation therapy (EBRT) was safe and tolerated in a SPORE Grant-supported investigator-initiated Phase 1 trial.
The twelve patients treated for locoregionally recurrent head and neck squamous cell carcinoma previously received chemoradiation alone (42%), surgery (58%) or surgery combined with radiation or chemoradiation (92%).
Complete remission was achieved in 64% of patients, with an ORR of 73% (n=11).
Before treatment with iopofosine I 131, six patients had multiple recurrence, and one had metastatic disease.
Additionally, the study demonstrated the durability of tumor control with an overall survival of 67% and progression-free survival of 42% at 12 months.
Overall, eleven patients (92%) experienced a treatment-related adverse event.
The most common treatment-related adverse events of any grade were thrombocytopenia (92%), lymphopenia (75%), neutropenia (75%), and anemia (92%).
Observed adverse events were consistent with the known toxicity profile of iopofosine I 131, with cytopenias being the most common with all patients recovering.
Roth Capital highlights the positive outcomes of iopofosine I 131 across various disease contexts, positioning Cellectar Biosciences as an appealing acquisition target.
“We note that iopofosine I 131 is showing benefit in several disease settings (e.g., WM, MM, DLBCL, HNSCC), which, in our view, only makes CLRB a more attractive acquisition target, despite it making a full effort to commercialize the drug itself,” Roth writes.
The analyst put a price target of $20.
Despite the company’s dedicated efforts to market the drug, its systemic administration suggests potential benefits in addressing the primary tumor and treating micrometastatic disease beyond conventional radiation boundaries.
In January, Cellectar Biosciences announced data from its CLOVER WaM pivotal study, evaluating iopofosine I 131, a targeted radiotherapy candidate for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia (WM) patients that have received at least two prior lines of therapy.
The CLOVER WaM study met its primary endpoint with a major response rate (MRR) of 61%.
The overall response rate (ORR) in evaluable patients was 75.6%, and 100% experienced disease control.
Price Action: CLRB shares are down 4.17% at $4.03 on the last check Monday.
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