辉瑞&默克的免疫治疗进展:PD-L1抗体Avelumab在进展期胃癌中的III期临床研究
 2017-12-16 腾医 


11月28日,默克集团和辉瑞公布了JAVELIN Gastric 300的III期临床试验中,PD-L1抗体Avelumab用于进展期胃癌的三线治疗的临床试验阶段性结果。与医生选择的化疗相比,avelumab单药没有达到更好的总体生存率。


这项临床试验探究了avelumab用于无法手术切除的复发性或转移性胃癌或胃食管交界(GEJ)腺癌的三线治疗,无论是否表达PD-L1受体,这些患者在经过两次前期治疗后疾病发生进展。Avelumab的安全性与JAVELIN临床发展计划的结论一致。


“胃癌进展到使用三线治疗已经是非常难治且异质性高的疾病,更重要的是,这是第一项在全球患者中进行的检查点抑制剂与化疗比较的临床试验 ,而不是与安慰剂比较。” 德国默克集团生物制药研发执行副总裁Luciano Rossetti说, 该公司在美国和加拿大掌管着默克雪兰诺,“研究数据将会提供给临床医生来治疗晚期癌症。我们将继续avelumab在胃癌中的研究项目,包括JAVELIN Gastric 100一线治疗的项目”。


我们将进一步核实JAVELIN Gastric 300项目的数据以更好地对结果进行解读,并且将在今后的医学大会上进行展示。JAVELIN Gastric 300的结果不会对现在avelumab的获批产生影响。



On November 28, Merck KGaA and Pfizer announced that the phase III JAVELINGastric 300 trial did not meet its primary endpoint of superior overallsurvival with single-agent avelumab (Bavencio) compared with physician's choiceof chemotherapy.

The trial investigated avelumab as a third-line treatment forunresectable, recurrent, or metastatic gastric or gastroesophageal junction(GEJ) adenocarcinoma patients whose disease progressed following two priortherapeutic regimens, regardless of programmed cell death ligand 1 (PD-L1)expression. The safety profile of avelumab was consistent with that observed inthe overall JAVELIN clinical development program.

 “Gastric cancer in the third-line setting is aparticularly hard-to-treat and heterogeneous disease, and importantly, this wasthe first trial conducted with a checkpoint inhibitor compared to an activechemotherapy comparator rather than placebo in a global patient population,” said Luciano Rossetti, MD, Executive Vice President, GlobalHead of Research & Development at the Biopharma Business of Merck KGaA,Darmstadt, Germany, which operates as EMD Serono in the U.S. and Canada. “Data from this study will provide valuable informationfor physicians treating this late-stage disease. We remain committed to ourongoing gastric cancer program with avelumab, including the JAVELIN Gastric 100 study in the first-line switchmaintenance setting.”

The JAVELIN Gastric 300 data willbe further examined in an effort to better understand the results and will alsobe submitted for presentation at an upcoming medical congress. The outcome ofJAVELIN Gastric 300 does not have any impact on current avelumab approvals.



Reference: 

Update on Phase III JAVELIN Gastric 300 Trial of Avelumab in Pretreated Advanced Gastric Cancer


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