DS5361 / Daiichi Sankyo - LARVOL DELTA

A phase 1, first-in-human study of DS5361, a small-molecule, nonsense-mediated mRNA decay (NMD) inhibitor in patients with advanced/metastatic solid tumors (parts 1 and 2). (ASCO 2026) - P1 | " DS5361-061 (NCT07182591) is a Phase 1, first-in-human, open-label, multicenter study (N≈66 for Parts 1 and 2) of DS5361 as monotherapy (Part 1) and in combination with pembrolizumab (Part 2). Secondary endpoints include objective response, disease control, and duration of response, all assessed by the investigator per RECIST 1.1, as well as pharmacokinetics. Enrollment is ongoing."

Clinical • First-in-human • IO biomarker • Metastases • P1 data • Tumor mutational burden • Microsatellite Instability • Oncology • Solid Tumor • MSI • TMB

Daiichi Sankyo Showcases Progress Across Industry-Leading Oncology Portfolio with Latest Research Updates at ASCO (Businesswire) - "New analyses from five landmark trials of Enhertu and Datroway in breast and gastric cancer alongside pipeline data across other tumor types demonstrate continued oncology leadership; Early phase trials-in-progress featuring potential medicines with novel mechanisms highlight the company’s commitment to identifying new breakthrough generating technologies for patients with cancer"

P1 data • P2 data • P3 data • Platinum resistant • Trial status • Acute Myelogenous Leukemia • Castration-Resistant Prostate Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Ovarian Cancer • Renal Cell Carcinoma • Triple Negative Breast Cancer • Urothelial Cancer

Trials-in-Progress Presentations Highlight Breakthrough Generating Technology Focus (Businesswire) - "Trials-in-progress poster presentations featuring three potential new medicines include DS3610 (TPS3159), a STING (stimulator of interferon genes) ADC, in patients with advanced or metastatic solid tumors; DS5361 (TPS2680), a small-molecule, nonsense-mediated mRNA decay inhibitor, in patients with advanced or metastatic solid tumors; and, DS9051 (TPS3179), a novel targeted protein degradation molecule, in patients with advanced or metastatic adrenocortical carcinoma or metastatic castration-resistant prostate cancer."

Trial status • Adrenal Cortex Carcinoma • Castration-Resistant Prostate Cancer

A Study of DS5361b in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=192 | Recruiting | Sponsor: Daiichi Sankyo

First-in-human • New P1 trial • Solid Tumor