DAIICHI SANKYO, INC.

Merck discontinues Phase 3 KeyVibe-008 trial evaluating a fixed-dose combination of vibostolimab and pembrolizumab in extensive-stage small cell lung cancer (ES-SCLC) patients due to meeting pre-specified futility criteria for overall survival (OS). Patients in the combination arm experienced higher rates of adverse events (AEs) and immune-related AEs compared to the control arm. Ongoing comprehensive analysis and further clinical development program expansions are noted.

The IDeate-Lung02 Phase 3 trial evaluating ifinatamab deruxtecan in relapsed small cell lung cancer has initiated, with the first patient dosed.

FDA issues Complete Response Letter for Daiichi Sankyo and Merck's patritumab deruxtecan BLA due to inspection findings at a third-party manufacturer, without issues identified with efficacy or safety data. Patritumab deruxtecan is a potential first-in-class HER3-directed ADC, jointly developed by Daiichi Sankyo and Merck, aiming to treat EGFR-mutated NSCLC patients previously treated with two or more systemic therapies.

Datopotamab deruxtecan's BLA accepted in the US for treating metastatic HR-positive, HER2-negative breast cancer, based on Phase III trial results showing significant PFS improvement over chemotherapy. FDA decision expected Q1 2025.