DS9051 / Daiichi Sankyo - LARVOL DELTA

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

A phase 1, first-in-human study of DS9051, a novel targeted protein degradation molecule, in patients with advanced/metastatic adrenocortical carcinoma (ACC) or metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2026) - P1 | "Secondary endpoints for both tumor types include objective response rate, disease control rate, clinical benefit rate, and duration of response (all assessed by the investigator, per RECIST 1.1 for ACC and per PCWG3 criteria for mCRPC); for ACC, progression-free survival (PFS) will be assessed by the investigator per RECIST 1.1, and for mCRPC, radiographic PFS and PSA decline will be assessed by the investigator per PCWG3 criteria. Enrollment is ongoing."

Clinical • First-in-human • Metastases • P1 data • Adrenal Cortex Carcinoma • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Targeted Protein Degradation

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

DS9051-079: First-in-Human trial of DS9051b in participants with advanced solid tumors (clinicaltrialsregister.eu) - P1 | N=15 | Not yet recruiting | Sponsor: Daiichi Sankyo Inc.

First-in-human • New P1 trial • Adrenal Cortex Carcinoma • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Daiichi Sankyo | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Adrenal Cortex Carcinoma • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Daiichi Sankyo

First-in-human • New P1 trial • Adrenal Cortex Carcinoma • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor