Merck & Co., Inc. (MRK) and Daiichi Sankyo (DSKYF.PK) announced that an interim analysis of the dose-optimization phase of the ongoing IDeate-Lung01 Phase 2 trial shows ifinatamab deruxtecan or I-DXd continued to demonstrate promising objective response rates in patients with pretreated extensive-stage small cell lung cancer or ES-SCLC.According to the companies, an objective response rate of 54.8% was observed with Daiichi Sankyo and Merck's ifinatamab deruxtecan at a 12 mg/kg dose in pretreated patients.

默克公司（Merck＆Co.，Inc。）和第一三共公司（Daiichi Sankyo）宣布，正在进行的IDeate-Lung01 2期临床试验的剂量优化阶段的中期分析显示，ifinatamab deruxtecan或I-DXd在预处理的广泛期小细胞肺癌或ES-SCLC患者中继续显示出有希望的客观缓解率。据这些公司称，第一三共和默克公司的ifinatamab deruxtecan在预处理患者中以12 mg/kg的剂量观察到客观缓解率为54.8%。

This dose has been selected as the optimal dose for the extension part of the IDeate-Lung01 Phase 2 trial and the recently initiated IDeate-Lung02 Phase 3 study.Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo, stated that the objective response rate and median overall survival of nearly a year along with the preliminary intracranial responses observed reinforced the potential for ifinatamab deruxtecan to improve outcomes for patients living with this difficult-to-treat type of lung cancer.

该剂量已被选为IDeate-Lung01 2期临床试验延伸部分和最近启动的IDeate-Lung02 3期研究的最佳剂量。Daiichi Sankyo肿瘤临床开发全球负责人Mark Rutstein医学博士表示，近一年的客观缓解率和中位总生存期以及观察到的初步颅内反应增强了ifinatamab deruxtecan改善这种难以治疗的肺癌患者预后的潜力。

Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck..

Ifinatamab deruxtecan是由Daiichi Sankyo发现并由Daiichi Sankyo和Merck联合开发的一种专门设计的，潜在的一流B7-H3定向抗体-药物偶联物（ADC）。。

Merck & Daiichi Sankyo noted that a confirmed objective response rate (ORR) of 54.8% and 26.1% were observed in patients with ES-SCLC receiving ifinatamab deruxtecan in the 12 mg/kg and 8 mg/kg cohorts, respectively, as assessed by blinded independent central review (BICR). Twenty-three partial responses were seen in the 12 mg/kg cohort.

默克和第一三共指出，根据盲法独立中央审查（BICR）的评估，分别在12 mg/kg和8 mg/kg队列中接受ifinatamab deruxtecan治疗的ES-SCLC患者的确诊客观缓解率（ORR）分别为54.8%和26.1%。在12 mg/kg队列中观察到23个部分反应。

One complete response and eleven partial responses were seen in the 8 mg/kg cohort.

在8 mg/kg队列中观察到一个完全缓解和十一个部分缓解。