RAHWAY, N.J.--(BUSINESS WIRE)---- $MRK #MRK--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as monotherapy for the treatment of resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adu ...

合作公告核心 - Flare Therapeutics与默克公司达成临床试验合作与供应协议，将评估FX-909与KEYTRUDA联合治疗局部晚期或转移性尿路上皮癌[1] - 联合疗法将在公司正在进行的1期研究中新增一个队列进行评估[1] 药物FX-909特性与进展 - FX-909是一款首创口服小分子PPARG抑制剂，PPARG是管腔谱系的主调控因子[1][3] - FX-909作为单药治疗已在1A期试验中达到临床概念验证[2][3] - FX-909直接靶向管腔癌细胞并驱动免疫调节，诱导促炎信号和循环T细胞扩增[2] 临床试验细节 - 联合治疗队列预计于2026年第一季度开始患者入组[2] - 该研究将调查FX-909剂量递增与标准剂量派姆单抗联合使用的安全性、耐受性、免疫学效应和初步疗效[2] 合作潜在影响 - FX-909与抗PD-1疗法联合可能克服免疫肿瘤疗法耐药性，为晚期尿路上皮癌的一线治疗、疾病早期阶段及其他PPARG驱动免疫逃避的实体瘤打开大门[2] 公司研发管线 - 公司主要专注于靶向转录因子以开发精准药物[3] - 第二个主要项目FX-111是一种新型、高度差异化的ARON降解剂，针对转移性去势抵抗性前列腺癌，正在进行新药临床试验申请所需的研究[3]

临床试验数据 - 在2025年欧洲肿瘤内科学会大会上公布了EFTISARC-NEO II期试验的积极数据，该试验评估了eftilagimod alfa联合放疗和KEYTRUDA用于可切除软组织肉瘤的新辅助治疗 [1] - 试验达到了主要终点，在可评估患者群体中，联合疗法实现了中位51.5%的肿瘤透明变性/纤维化，显著超过了预设的35%目标 [1] - 该结果比历史数据中单独使用标准放疗的15%高出三倍以上，肿瘤透明变性/纤维化是与改善总生存期和无复发生存期相关的早期替代终点 [1] - 该疗法在多种软组织肉瘤亚型中均取得良好结果，并且安全性良好，仅有一例与免疫疗法相关的≥3级毒性 [1] 产品机制与潜力 - Eftilagimod alfa是一种新型免疫疗法，通过MHC II类途径直接激活抗原呈递细胞，从而启动广泛的抗癌免疫反应 [4] - 其独特机制可能通过改变免疫抑制的肿瘤微环境，在具有显著未满足医疗需求的软组织肉瘤中实现显著抗癌疗效 [2] - 软组织肉瘤是一种孤儿疾病，预后差，据美国癌症协会估计，2025年美国新发病例约13,520例，死亡约5,420例 [2] 研发管线与监管进展 - Efti正在多种实体瘤中进行评估，包括一项针对非小细胞肺癌的关键III期试验TACTI-004，以及头颈鳞状细胞癌、软组织肉瘤和乳腺癌 [6] - 其良好的安全性支持与抗PD-[L]1免疫疗法、放疗和/或化疗的多种组合 [6] - Efti已获得美国FDA在头颈鳞状细胞癌一线治疗和非小细胞肺癌一线治疗中的快速通道资格 [6] 公司背景 - Immutep是一家专注于针对癌症和自身免疫性疾病开发新型免疫疗法的晚期生物技术公司 [7] - 公司在淋巴细胞激活基因-3的理解和治疗进展方面是先驱，其多元化产品组合利用LAG-3来刺激或抑制免疫反应 [7]

BT-001 in combination with pembrolizumab is well tolerated and shows sustained antitumoral activity in both injected and non-injected lesions Data support further development of BT-001 in solid tumors to improve response to cancer immunotherapy Strasbourg, France, and Lund, Sweden, October 20, 2025, 08:30 a.m. CEST – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and BioInvent International AB (“BioInvent”) (Nasdaq Stock ...

BT-001 in combination with pembrolizumab is well tolerated and shows sustained antitumoral activity in both injected and non-injected lesions Data support further development of BT-001 in solid tumors to improve response to cancer immunotherapy Strasbourg, France, and Lund, Sweden, October 20, 2025, 08:30 a.m. CEST – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and BioInvent International AB (“BioInvent”) (Nasdaq Stock ...

Cylembio plus pembrolizumab achieved a clinically relevant 19.4 months median progression free survival (mPFS) compared to 11.0 months mPFS with pembrolizumab alone; study narrowly missed progression free survival (PFS) primary endpoint for statistical significance Improvement in PFS favored the combination across virtually all subgroups, notably in patients with PD-L1-negative tumors, BRAFV600-mutated tumors, and elevated LDH, without adding any systemic toxicity compared to pembrolizumab alone Final data ...

临床试验数据公布 - 公司首次公布关键三期KEYNOTE-B96试验结果 [1] - 该试验评估KEYTRUDA联合化疗用于治疗铂类耐药复发性卵巢癌患者 [1] - 这些最新突破性数据将在学术会议上进行展示 [1]

核心观点 - KEYTRUDA联合Padcev作为肌层浸润性膀胱癌患者术前术后治疗方案 相比单独手术可将无事件生存事件风险降低60% 并将死亡风险降低50% [1] 临床试验结果 - 在LEAP-015临床试验中 KEYTRUDA联合Padcev方案对比当前标准护理单独手术显示出显著优势 [1] - 该联合疗法针对不适合接受以顺铂为基础化疗的肌层浸润性膀胱癌患者 [1] 治疗方案 - 联合治疗方案应用于根治性膀胱切除术之前和之后 [1]

75% Objective Response Rate as 12 out of 16 advanced melanoma patients had objective clinical responses, with 11 of the 12 responders continuing to respond at 24 months follow-upImmune activation observed in all patients with 81% of EVX-01’s vaccine targets triggering a specific responseTreatment was well toleratedData is presented today at the ESMO Congress and will be discussed at a webinar with key opinion leader Professor Muhammad Adnan Khattak on October 22, 2025 COPENHAGEN, Denmark, October 17, 2025 - ...

临床试验结果 - 公司宣布其KEYNOTE-B96三期临床试验达到次要终点总生存期 [1] - 该试验针对铂类耐药复发性卵巢癌患者 在所有入组患者中均显示OS获益 [1] - 试验方案为KEYTRUDA联合化疗 并研究联合或不联合贝伐珠单抗的效果 [1] 试验药物 - 试验药物为KEYTRUDA 是公司的抗PD-1疗法 [1] - KEYTRUDA与化疗药物紫杉醇联合使用 [1]