DAIICHI SANKYO, INC.

Merck and Daiichi Sankyo announced interim Phase 2 trial results for lung cancer treatment ifinatamab deruxtecan (I-DXd), showing objective response rates of ~55% and ~26% at 12 mg/kg and 8 mg/kg doses, respectively. The 12 mg/kg dose led to 23 partial responses, while the 8 mg/kg dose resulted in one complete and 11 partial responses. Median overall survival was 11.8 months and 9.4 months for the respective doses. Preliminary intracranial ORRs were 50.0% and 66.7% across the two dose groups. Adverse events led to 17% and 6.5% dropouts for the respective doses. The 12 mg/kg dose is selected for the trial's expansion part, with data to be presented at the World Conference on Lung Cancer in San Diego.

Daiichi Sankyo and Merck's ifinatamab deruxtecan shows 54.8% ORR at 12 mg/kg in pretreated ES-SCLC patients, selected as optimal dose for IDeate-Lung01 phase 2 trial extension and IDeate-Lung02 phase 3 study.

Linker chemistry in antibody-drug conjugates (ADCs) plays a crucial role in cancer therapies, determining payload release and efficacy. Despite 11 FDA-approved ADCs and 266 clinical trials, the complexity of linkers remains a challenge, influencing ADC stability, toxicity, and target specificity. Innovations like PEG linkers and click chemistry aim to enhance ADC performance, but the field still lacks definitive rules for optimal linker design.

Ifinatamab deruxtecan shows promising objective response rates in pretreated extensive-stage small cell lung cancer patients in the IDeate-Lung01 phase 2 trial, with confirmed ORR of 54.8% and 26.1% in 12 mg/kg and 8 mg/kg cohorts, respectively.

At the ESC conference, Thomas Hauser presented results showing Novartis's XXB750, a natriuretic peptide receptor A agonist, is safe and well tolerated in chronic stable HF patients with reduced or mildly reduced EF, administered subcutaneously. The study supports monthly dosing, with mild adverse events observed.

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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.

The precision medicine market, valued at $73.11 billion in 2023, is projected to grow to $118.08 billion by 2028, driven by rising cancer prevalence and strategic collaborations. It segments by technology, application, and end-use, with major players including Roche, Pfizer, and Novartis.