Merck & Daiichi Sankyo's Ifinatamab Deruxtecan Shows Promising Results In Phase 2 Lung Cancer Trial

(RTTNews) - 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. 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.

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.

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

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