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

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

尽管达成了血液癌症研究目标,以癌症为重点的cellectar biosciences股票仍然下跌交易。
Benzinga ·  07/23 10:49

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

纳斯达克的Cellectar Biosciences股票周二下跌,因该公司发布了其CLOVER Wam关键研究结果。

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.

该研究评估了狙击放射性候选药物Iopofosine I 131,用于复发/难治的沃尔登斯特龙巨球蛋白症(WM)——一种始发于白血细胞的癌症。

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.

截至5月31日,CLOVER Wam研究的结果显示总体反应率(ORR)为80%,主要反应率(MRR)为56.4%。结果超过了商定的20%MRR的主要终点。

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.

治疗前的中位数为4条,约27%的患者对所有可用疗法具有难治性,40%的患者具有双类难治性。

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.

一月份,当公司报告早期数据时,CLOVER Wam研究在可评估患者中显示出61%的MRR,75.6%的ORR和100%的疾病控制率。

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.

相似的ORR在所有疾病亚组中观察到,包括:MYD88-wt(81%; n = 16),P53-mutated(80%; n = 5)和临床患者队列,包括发帖-BTKi(72%; n = 39),以及双类(59%; n =22)和三类(53%; n = 15)难治患者。

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.

疾病控制率的二级终点(98.2%)和反应持续时间(DoR)提供了证据,表明Iopofosine提供了所有反应类别的持久临床益处。

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.

截至数据截止日期,取得主要反应和总体反应的患者的中位DoR尚未达到,分别为18个月,其中78%和72%仍然没有疾病进展。

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

该公司计划在2024年第四季度提交FDA营销申请。

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

Iopofosine I 131被很好地耐受,并且其毒性特征与公司先前报告的安全数据一致。

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

与其他癌症治疗不同,接受Iopofosine治疗的患者没有经历心血管,肾脏或肝脏毒性。

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

最常报告的治疗新发不良事件的性质为血液学(血小板减少症,中性粒细胞减少症和贫血症),可预测和可管理。

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

所有患者在达到最低点后的几周内从细胞减少症中恢复过来。

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

该公司表示,CLOVER Wam是迄今为止高度难治人群中最大的Wm研究。

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

Milestone Scientific的股票CLRb周二最后一次检查下跌24.83%,至2.27美元。

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