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10 Jun 2022
Admin
News Article

Daiichi Sankyo Sarah Cannon Announce Initial Results From Phase 1 Study Of Ds-6000 To Treat Advanced Ovarian Cancer Or Renal Cell Carcinoma

Daiichi Sankyo And Sarah Cannon Research Institute (Sarah Cannon) Announced That Initial Results From The First-In-Human Phase 1 Study Of Ds-6000, A Cdh6 Directed Dxd Antibody Drug Conjugate (Adc), Suggest Early Clinical Activity In Patients With Advanced Ovarian Cancer Or Renal Cell Carcinoma With Disease Progression Following Standard Of Care Treatment. The Data Were Presented Today In An Oral Session (Abstract #3002) At The American Society Of Clinical Oncology (#Asco22) Annual Meeting.Patients With Advanced Ovarian Cancer Or Renal Cell Carcinoma May Have Disease Progression After Initial Treatments And There Is A Need For New Therapeutic Approaches For Recurrent Disease, As Five-Year Survival Rates In The Us Are Low At 30% And 15%, Respectively. The Cdh6 Protein Is Significantly Overexpressed In Ovarian Cancer And Renal Cell Carcinoma And Has Been Identified As A Promising Therapeutic Target.Preliminary Safety And Efficacy Results Of Ds-6000 Were Reported From The Dose Escalation Part Of The Phase 1 Trial In 30 Heavily Pretreated Patients, Including 21 Patients With Advanced Ovarian Cancer, One Of Which Was Missing A Primary Diagnosis Of Ovarian Cancer, And Nine Patients With Renal Cell Carcinoma.The Safety And Tolerability Of Ds-6000 Was Evaluated At Increasing Dose Levels From 1.6 Mg/Kg To 9.6 Mg/Kg With Two Dose-Limiting Toxicities Observed At The 9.6 Mg/Kg Dose (Grade 3 Febrile Neutropenia And Grade 4 Thrombocytopenia). The Most Common Treatment-Related Emergent Adverse Events (Teaes) (= 10% Of Patients) Reported Were Nausea (60.0%), Fatigue (56.7%), Vomiting (30.0%), Neutrophil Count Decrease (23.3%), Decreased Appetite (20.0%), And Diarrhea (13.3%). Grade = 3 Teaes Occurred In Seven Patients (23.3%), The Most Common Of Which Were Neutrophil Count Decrease (16.7%), Anemia (6.7%) And Febrile Neutropenia (6.7%). One Patient Experienced Grade 2 Pneumonitis At The 9.6 Mg/Kg Dose That Led To Treatment Discontinuation.Preliminary Efficacy Resultsin 20 Evaluable Patientsincluded Six Partial Responses (Prs) In Patients With Ovarian Cancer (N=5) And Renal Cell Carcinoma (N=1). Four Prs Were Confirmed And Two Are Awaiting Confirmation. Stable Disease Was Reported In 12 Patients With Platinum-Resistant Ovarian Cancer. Eight Ca125 Responses Were Observed In 17 Evaluable Patients With Ovarian Cancer, Based On The Gynecologic Cancer Intergroup (Gcig) Criteria

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