Purple Biotech Reported Final Results From Phase 2 Study Of Its Lead Oncology Drug, CM24, In Patients With Pancreatic Ductal Adenocarcinoma
Purple Biotech Reported Final Results From Phase 2 Study Of Its Lead Oncology Drug, CM24, In Patients With Pancreatic Ductal Adenocarcinoma
purple biotech發佈了其主要抗腫瘤藥物CM24在胰腺導管腺癌患者中的第二階段研究的最終結果
- Final data demonstrate CM24 in combination with nivolumab and Nal-IRI/5FU/LV chemotherapy clear and consistent improvement across all efficacy endpoints.
- A biomarker enriched patient population analysis based on pretreatment ranges of serum CEACAM1 demonstrated significant improvement in the treatment arm over the control of 79% reduction in risk of death (HR 0.21, P = 0.04) with median OS improvement of 5.1 months and over 90% reduction in risk of progression or death (HR < 0.1, P = 0.003) with median PFS improvement of 2.9 months and improvement in the treatment arm over the control in ORR of 50% vs. 0%.
- Phase 2b clinical study is planned in multiple selected indications, potentially targeting patients based on biomarkers
- 最終數據表明CM24與nivolumab和Nal-IRI/5FU/LV化療聯合應用在所有療效終點上均取得明顯和一致的改善。
- 基於術前血清CEACAM1水平範圍的生物標誌富集患者人群分析顯示，在治療組中與對照組相比，死亡風險減少79%（HR 0.21，P = 0.04），中位生存期延長5.1個月，並且進展或死亡風險減少90%以上（HR
- 計劃在多個選定適應症中進行20億臨床研究，可能根據生物標誌靶向患者。
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