On Monday, Purple Biotech Ltd (NASDAQ:PPBT) reported the final results from the randomized Phase 2 study of its lead oncology drug, CM24, a humanized monoclonal antibody that blocks CEACAM1, in patients with pancreatic ductal adenocarcinoma (PDAC).
Purple Biotech stock is trading higher with a strong session volume of 9.7 million, compared to an average volume of 48.73K as per data from Benzinga Pro.
The Phase 2 study evaluated CM24 in combination with Bristol Myers Squibb & Co's (NYSE:BMY) immune checkpoint inhibitor nivolumab plus stand-of-care (SoC) chemotherapy in second-line metastatic PDAC patients versus SoC chemotherapy alone.
In the intent-to-treat cohort population, the median overall survival rate was 7.92 months in the CM24 combo treatment arm versus 5.55 months in the chemo arm.
The median progression-free survival was 3.9 months versus 2.0 months.
The overall response rate was 25% versus 7%, and the disease control rate was 63% compared to 47% in the CM24 combo arm vs. chemo alone group.
A consistent and continuous decrease of CA19-9, a clinically validated PDAC biomarker, was observed in the experimental arm, reaching a median percentage reduction from baseline of approximately 80% vs. an increase of 40% in the control arm.
A biomarker-enriched patient population analysis based on pretreatment ranges of serum CEACAM1 demonstrated significant improvement in the treatment arm over the control, with a 79% reduction in the risk of death and a median overall survival improvement of 5.1 months.
Over 90% reduction in risk of progression or death was observed, with a median progression-free survival improvement of 2.9 months and improvement in the treatment arm over the control, resulting in an overall response rate of 50% vs. 0%.
The CM24+nivolumab+Nal/IRI/5FU/LV regimen was well tolerated. The most frequent treatment-emergent Grade 3 or higher adverse events were diarrhea, fatigue, and neutropenia.
Accordingly, no meaningful differences in safety and tolerability were observed between the experimental arm and the SoC arm.
Price Action: PPBT stock is up 54.1% at $5.17 during the premarket session at last check Monday.
週一，Purple Biotech Ltd（納斯達克股票代碼：PPBT）公佈了其主要腫瘤藥物CM24（一種阻斷 CEACAM1 的人源化單克隆抗體）對胰腺導管腺癌（PDAC）患者進行的隨機2期研究的最終結果。
根據Benzinga Pro的數據，Purple Biotech股票交易量走高，交易量強勁，爲970萬，而平均交易量爲4.873萬。
第二階段研究評估了CM24與百時美施貴寶公司（紐約證券交易所代碼：BMY）免疫檢查點抑制劑nivolumab加上待遇（SoC）化療對二線轉移性PDAC患者的聯合治療，與單獨使用SoC化療相比。
在意向治療隊列中，CM24組合治療組的總存活率中位數爲7.92個月，而化療組的總存活率中位數爲5.5萬個月。
無進展存活率中位數爲3.9個月，而2.0個月。
總體緩解率爲25％對7％，疾病控制率爲63％，而CM24組合組與單獨化療組的疾病控制率爲47％。
在實驗組中觀察到經臨床驗證的 PDAC 生物標誌物 CA19-9 持續下降，與基線相比中位數下降了約 80%，而對照組的增幅爲 40%。
一項基於血清 CEACAM1 預治療範圍的富含生物標誌物的患者群體分析顯示，治療組比對組有顯著改善，死亡風險降低了 79%，總存活率中位數提高了 5.1 個月。
觀察到進展或死亡風險降低了90％以上，無進展存活率中位數提高了2.9個月，治療組的改善高於對照組，因此總體緩解率爲50％對0％。
CM24+nivolumab+NAL/IRI/5FU/LV 方案的耐受性良好。最常見的治療緊急3級或更高不良事件是腹瀉、疲勞和中性粒細胞減少。
因此，實驗組和SoC組之間在安全性和耐受性方面沒有觀察到有意義的差異。
價格走勢：在週一最後一次盤前交易中，PPBT股價上漲54.1％，至5.17美元。
