DS-9606 / Daiichi Sankyo - LARVOL DELTA

REFMAL 823: A Study of DS-9606a in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=88 | Terminated | Sponsor: Daiichi Sankyo | Active, not recruiting ➔ Terminated; It was Daiichi Sankyo, Inc.'s decision to discontinue further internal development of DS-9606a

First-in-human • Trial termination • Endometrial Cancer • Gastric Cancer • Germ Cell Tumors • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Daiichi stops internal development of next-wave ADC... (FierceBiotech) - "Daiichi has ended internal development of DS-9606, a CLDN6-directed ADC 'following a strategic portfolio review', Daiichi’s R&D head Yuki Abe said during the company’s quarterly investor call Jan. 30. Abe suggested that 'there is room for development' of DS-9606 with potential partners, given it has generated good results in germ cell tumor."

Pipeline update • Germ Cell Tumors

Preliminary results from a phase I, first-in-human study of DS-9606a, a claudin 6 (CLDN6)-directed antibody-drug conjugate (ADC), in patients (pts) with tumor types known to express CLDN6 (ESMO 2024) - P1 | "DS-9606a had a favorable safety profile, with no dose-limiting toxicity, dose-dependent increase in TEAEs or treatment discontinuations; preliminary efficacy is promising. MTD and RDE are not yet determined. Enrollment is ongoing."

Clinical • P1 data • Gastric Cancer • Gastrointestinal Cancer • Germ Cell Tumors • Oncology • Solid Tumor • CLDN6

REFMAL 823: A Study of DS-9606a in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=88 | Active, not recruiting | Sponsor: Daiichi Sankyo | Recruiting ➔ Active, not recruiting

Enrollment closed • Endometrial Cancer • Gastric Cancer • Germ Cell Tumors • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

DS-9606 Shows Promising Preliminary Clinical Activity in Patients with Advanced Solid Tumors (Businesswire) - P1 | N=85 | NCT05394675 | Sponsor: Daiichi Sankyo | "Initial results from dose escalation in the first-in-human phase 1 trial of DS-9606 suggest early promising clinical activity in patients with advanced solid tumors known to express Claudin-6 (CLDN6)....Preliminary efficacy results were observed in doses greater than or equal to 0.072 mg/kg (except 0.190 mg/kg due to immature data) and included four confirmed objective responses including two responses observed in patients with GCT and one response each in patients with gastric/esophageal cancer and NSCLC. Of seven evaluable patients with GCT, the two patients with confirmed objective response remained on treatment for more than six months and five had a greater than or equal to 90% reduction in alpha-fetoprotein and human chorionic gonadotropin tumor markers. Twenty one of the 53 patients are still receiving treatment with DS-9606 as of data cutoff of June 14, 2024."

P1 data • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Germ Cell Tumors • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Daiichi Sankyo Unveils New Research Across Industry-Leading ADC Portfolio in Multiple Cancers at WCLC and ESMO (Businesswire) - "Data at WCLC and ESMO showcasing Daiichi Sankyo’s progress towards its goal of creating new standards of care for patients with cancer will include six late-breaking presentations, including two back-to-back presentations during Presidential Symposium 1 featuring datopotamab deruxtecan (Dato-DXd) data at WCLC, and the first presentation of clinical data of DS-9606, a CLDN6 directed modified pyrrolobenzodiazepine (PBD) ADC from Daiichi Sankyo’s second ADC platform, at ESMO."

Clinical data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of DS-9606a in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=85 | Recruiting | Sponsor: Daiichi Sankyo | N=125 ➔ 85

Enrollment change • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Germ Cell Tumors • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

A Study of DS-9606a in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=125 | Recruiting | Sponsor: Daiichi Sankyo, Inc. | Trial completion date: Nov 2023 ➔ Feb 2026 | Trial primary completion date: Nov 2023 ➔ Feb 2026

Metastases • Trial completion date • Trial primary completion date • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Germ Cell Tumors • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

"DS-9606ahttps://www.adcreview.com/drugmap/ds-9606a/" (@OncoZine)

Review

A Study of DS-9606a in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=125 | Recruiting | Sponsor: Daiichi Sankyo, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Germ Cell Tumors • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

A Study of DS-9606a in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=125 | Not yet recruiting | Sponsor: Daiichi Sankyo, Inc.

New P1 trial • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Germ Cell Tumors • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor