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默沙东与百时美施贵宝近日分别与礼来签署了肿瘤免疫疗法的试验协议，用以评估其各自的PD-1抑制剂与礼来肿瘤药联合疗法的效果，可以看做是两家制药巨头在肿瘤免疫疗法的新一轮竞争。
默沙东将会通过多重临床试验测试旗下明星肿瘤免疫药Keytruda (pembrolizumab)与礼来肿瘤药联用的安全性、耐受性和有效性。
按照协议条款，默沙东将会开展Keytruda和礼来Alimta (pemetrexed)联用治疗非小细胞肺癌的2期临床研究。礼来则会负责Cyramza (ramucirumab)/Keytruda在多种肿瘤治疗领域的1期和2期临床试验，以及necitumumab/Keytruda治疗非小细胞肺癌的1期/2期临床试验。
百时美施贵宝与礼来合作的临床试验主要是针对其肿瘤免疫药Opdivo (nivolmab)和礼来的试验性新药galunisertib (LY2157299)在晚期胶质母细胞瘤、肝细胞癌和非小细胞肺癌的潜在应用价值。
而礼来的galunisertib的2期临床评估也正由百时美进行，galunisertib是一种用于治疗多种晚期或转移性恶性肿瘤的口服药物，目前主它的疗效要针对肝细胞癌、骨髓增生异常综合征、恶性胶质瘤和胰腺癌。
Keytruda 和Opdivo同被FDA批准用于治疗黑色素瘤，并且目前默沙东和百时美都已提交治疗非小细胞肺癌的申请。默沙东日前宣布，Keytruda有望在2015年中期获批治疗无ALK或EGFR突变的非小细胞肺癌，而百时美日前也已宣布Opdivo能非常有效地延长肺癌患者的生存率。二者各自与礼来展开合作，也为PD-1抑制剂领域的竞争增添了许多戏剧性。
原文 Merck & Co， B-MS sign immunotherapy pacts with Lilly
Merck & Co and Bristol-Myers Squibb have signed separate onco-immunology focused trial agreements with Eli Lilly to assess combinations of their rival PD-1 inhibitors with the latter’s cancer drugs.
The Merck alliance will test the safety， tolerability and efficacy of combining its flagship immunotherapy Keytruda (pembrolizumab) with Lilly compounds across multiple clinical trials.
Under the terms of the agreement， Merck will conduct a Phase II study assessing a mix of Keytruda and Lilly’s Alimta (pemetrexed) in first-line non-squamous， non-small cell lung cancer (NSCLC)， which is currently enrolling.
Lilly will carry out a multiple-arm Phase I/II study looking at Cyramza (ramucirumab)/Keytruda in multiple tumours， as well a Phase I/II study of necitumumab/Keytruda in NSCLC， both of which are scheduled to begin this year.
Further terms were not disclosed.
B-MS deal
The B-MS deal will see a combination of its immunotherapy Opdivo (nivolmab) and Lilly’s investigational drug galunisertib (LY2157299) put through clinical trials to test potential in advanced glioblastoma， hepatocellular carcinoma and NSCLC.
The study will be conducted by Lilly. Additional details were not disclosed.
Galunisertib is currently being assessed by B-MS as an oral treatment for advanced/metastatic malignancies， including Phase II evaluation in hepatocellular carcinoma， myelodysplastic syndromes (MDS)， glioblastoma， and pancreatic cancer.
Both Keytruda and Opdivo are approved in the US for advanced melanoma， and both are now racing to bag approval for patients with NSCLC. Merck announced Sunday that it intends to file Keytruda for the treatment of NSCLC patients without ALK or EGFR mutations by mid-2015， while B-MS unveiled ueber-promising late-stage data for Opdivo showing a significant survival benefit in patients with advanced， squamous forms of the disease.
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