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PADCEV™ Plus KEYTRUDA™, Given Before and After Surgery, Cuts the Risk of Recurrence, Progression or Death by 60% and the Risk of Death by 50% for Certain Patients with Bladder Cancer
Prnewswire· 2025-10-18 22:30
Accessibility StatementSkip Navigation TOKYO and NEW YORK, Oct. 18, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced positive results from the pivotal Phase 3 EV-303 clinical trial (also known as KEYNOTE-905) for PADCEVÂ (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with KEYTRUDAÂ (pembrolizumab), a PD-1 inhibitor. The study evaluated the combination in patients with muscle-inva ...
Corbus Pharmaceuticals to Present CRB-701 Phase 1/2 Data at ESMO 2025
Globenewswire· 2025-10-14 20:00
Data to be presented for 167 enrolled participants of which 122 were evaluable for efficacy Company to host HNSCC KOL event to review and discuss data NORWOOD, Mass., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP), a clinical stage company focused on oncology and obesity, announced today the European Society for Medical Oncology (ESMO) Congress 2025 abstract for its Phase 1/2 clinical study has been released. Updated data will be presented as a poster during ESMO. Th ...
GILD Announces Positive Data on Trodelvy in First-Line Breast Cancer
ZACKS· 2025-05-26 22:21
核心观点 - 公司宣布Trodelvy在治疗一线转移性三阴性乳腺癌(mTNBC)的III期ASCENT-03研究中取得积极顶线结果,显示无进展生存期(PFS)具有高度统计学显著性和临床意义的改善 [1] - 这是Trodelvy在治疗一线mTNBC中第二个取得积极结果的III期研究 [2] - 公司股价年内上涨17.1%,而行业整体下跌5% [4] Trodelvy研究数据 - ASCENT-03是一项全球、开放标签、随机III期试验,评估Trodelvy对比医生选择治疗方案在约540名未经治疗的局部晚期不可切除mTNBC患者中的疗效和安全性 [5][6] - 研究达到主要终点,显示Trodelvy相比化疗在一线mTNBC患者中PFS有显著改善 [6] - 安全性特征与既往研究一致,总生存期(OS)数据尚未成熟,将继续监测 [7] - Trodelvy目前已在50多个国家获批用于二线或更晚期的mTNBC患者 [8] Trodelvy市场潜力 - 上月公布的ASCENT-04/KEYNOTE-D19研究显示Trodelvy联合Keytruda相比Keytruda加化疗显著改善PFS [8][9] - ASCENT-03和ASCENT-04的积极数据表明Trodelvy有潜力成为一线mTNBC的基础治疗方案 [9] - 公司正在进行多项III期研究评估Trodelvy在HER2乳腺癌等其他适应症中的应用 [10] 公司业务发展 - 公司肿瘤学产品组合包括细胞疗法和Trodelvy,但细胞疗法在美国和欧洲面临竞争压力 [11] - 预计2026年anito-cel在多发性骨髓瘤和Trodelvy在一线mTNBC的上市将加强肿瘤业务 [12] - 公司在HIV市场占据主导地位,创新HIV产品组合有助于应对GSK的竞争 [12] - 管线候选药物lenacapavir在HIV预防中显示100%疗效,FDA已接受其新药申请并给予优先审查 [13] - 公司与默克合作评估islatravir和lenacapavir联合治疗HIV的潜力 [14]