原始出處紀錄
重大申請已送件
Candel 計劃於 2026 年 Q4 提交 CAN-2409 用於攝護腺癌的 BLA
該公司宣布將針對中至高風險局部攝護腺癌提交 CAN-2409 的 BLA，提交時間為 2026 年 Q4。此申請將以第 3 期試驗的正面數據為基礎，顯示攝護腺癌特異性 DFS 有統計學顯著改善（HR 0.62，p=0.0046），並由持續的 CMC 及法規準備活動支持。
關鍵事實
來源摘錄
EX-99.1 2 cadl-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Candel Therapeutics Reports Third Quarter 2025 Financial Results and Recent Corporate Highlights • Presented new subgroup analyses from phase 3 clinical trial of CAN-2409 in localized prostate cancer at the American Society for Radiation Oncology (ASTRO) 2025 meeting, demonstrating improved prostate cancer-specific disease-free survival (DFS), independent of radiation therapy modality utilized • Company plans to initiate pivotal phase 3 clinical trial of CAN-2409 in patients with metastatic, non-squamous, non-small cell lung cancer (NSCLC) and progressive disease, despite immune checkpoint inhibitor (ICI) treatment, in Q2 2026 • Announced encouraging updated survival data for patients enrolled in its phase 1b clinical trial of CA