Cancer-Focused Cellectar Biosciences Stock Trades Lower Despite Meeting Goal In Blood Cancer Study

Cellectar Biosciences Inc. CLRB stock is trading lower Tuesday after the company shared results from its CLOVER WaM pivotal study.

The study evaluated iopofosine I 131, a targeted radiotherapeutic candidate, for relapsed/refractory Waldenstrom’s macroglobulinemia (WM) — a type of cancer that begins in the white blood cells.

As of May 31, the CLOVER WaM study’s results had an overall response rate (ORR) of 80% and a major response rate (MRR) of 56.4%. Results exceeded the agreed-upon primary endpoint of a 20% MRR.

The median number of prior lines of therapy was four, with approximately 27% of patients refractory to all available therapies and 40% of patients dual-class refractory.

In January, when the company reported early data, the CLOVER WaM study showed MRR of 61%, ORR of 75.6% in evaluable patients, and 100% experienced disease control. 

The comparable ORRs were observed across all disease subgroups, including: MYD88-wt (81%; n=16), P53-mutated (80%; n=5), and clinical patient cohorts including post-BTKi (72%; n=39), as well as dual-class (59%; n=22), and triple-class (53%; n=15) refractory patients.

Secondary endpoints of disease control rate (98.2%) and duration of response (DoR) presented evidence that iopofosine provided durable clinical benefit across all response categories.

The median DoR in patients achieving major response and overall response were not reached as of the data cutoff, with 78% and 72% remaining free from disease progression at 18 months, respectively.

The company plans to file an FDA marketing application in the fourth quarter of 2024.

Iopofosine I 131 was well tolerated and its toxicity profile was consistent with the company’s previously reported safety data.

Unlike other cancer therapies, patients on iopofosine did not experience any cardiovascular, renal, or liver toxicities.

The most commonly reported treatment-emergent adverse events were hematologic in nature (thrombocytopenia, neutropenia and anemia) and were predictable and manageable.

All patients recovered from cytopenias within a few weeks post nadir.

The company says that CLOVER WaM is the first and largest WM study to date in a highly refractory patient population.

Price Action: CLRB stock was down 24.83% at $2.27 at last check Tuesday.

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