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
Cellectar Biosciences Inc. (NASDAQ:CLRB) stock is trading lower Tuesday after the company shared results from its CLOVER WaM pivotal study.
Cellectar Biosciences Inc.(納斯達克股票代碼:CLRB)週二股價走低,此前該公司公佈了其CLOVER Wam關鍵研究的結果。
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.
該研究評估了針對復發/難治性瓦爾登斯特龍巨球蛋白血癥(WM)(一種始於白細胞的癌症)的靶向放射治療候選藥物iopofosine I 131。
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的研究結果顯示,總體回應率(ORR)爲80%,主要回應率(MRR)爲56.4%。結果超過了商定的主要終點,即20%的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.
先前治療的中位數爲四個,約有27%的患者對所有可用療法有耐藥性,40%的患者是雙類難治性的。
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.
今年1月,當該公司公佈早期數據時,CLOVER Wam的研究顯示,可評估患者的MRR爲61%,可評估患者的ORR爲75.6%,100%的人經歷了疾病控制。
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.
在所有疾病亞組中觀察到可比的ORR,包括:myd88-WT(81%;n=16)、p53突變(80%;n=5),臨床患者群組,包括BTKI後(72%;n=39),以及雙類(59%;n=22)和三類(53%;n=15)難治性患者。
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(98.2%)和緩解持續時間(DoR)的次要終點提供了證據,表明異泊氟辛在所有反應類別中都提供了持久的臨床益處。
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.
截至數據截止日期,尚未達到取得重大反應的患者的中位DoR和總體緩解,分別有78%和72%在18個月時沒有疾病進展。
The company plans to file an FDA marketing application in the fourth quarter of 2024.
該公司計劃在2024年第四季度提交美國食品藥品管理局的營銷申請。
Iopofosine I 131 was well tolerated and its toxicity profile was consistent with the company's previously reported safety data.
Iopofosine I 131的耐受性良好,其毒性特徵與該公司先前報告的安全數據一致。
Unlike other cancer therapies, patients on iopofosine did not experience any cardiovascular, renal, or liver toxicities.
與其他癌症療法不同,服用iopofosine的患者沒有任何心血管、腎臟或肝臟毒性。
The most commonly reported treatment-emergent adverse events were hematologic in nature (thrombocytopenia, neutropenia and anemia) and were predictable and manageable.
最常報告的治療突發性不良事件本質上是血液學性的(血小板減少、中性粒細胞減少和貧血),是可預測和可控的。
All patients recovered from cytopenias within a few weeks post nadir.
所有患者都在最低點後的幾周內從血細胞減少中恢復過來。
The company says that CLOVER WaM is the first and largest WM study to date in a highly refractory patient population.
該公司表示,CLOVER Wam是迄今爲止針對高難治患者群體的第一項也是最大的Wm研究。
Price Action: CLRB stock was down 24.83% at $2.27 at last check Tuesday.
價格走勢:在週二的最後一次檢查中,ClRb股價下跌24.83%,至2.27美元。
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