SAR566658 / Sanofi, AbbVie - LARVOL DELTA

Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients With CA6 Positive Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - P2; N=23; Terminated; Sponsor: Sanofi; Completed ➔ Terminated; Study discontinued considering the limited clinical benefit combined with a higher than expected rate of known non-serious ophthalmological event.

Clinical • Trial termination • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

An antibody drug conjugate targeting MUC1 associated carbohydrate CA6, shows promising anti-tumor activities. (PubMed, Mol Cancer Ther) - "SAR566658 displayed better efficacy than standard of care non-targeted tubulin binders. This data supports the development of SAR566658 in patients with CA6 expressing tumors."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • MUC1

Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients With CA6 Positive Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - P2; N=62; Not yet recruiting; Sponsor: Sanofi

New P2 trial • Biosimilar • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Triple Negative Breast Cancer

A Phase I first-in-human (FIH) study of SAR566658, an anti CA6-antibody drug conjugate (ADC), in patients (Pts) with CA6-positive advanced solid tumors (STs) (NCT01156870) (AACR-NCI-EORTC 2013) - Abstract #A73; Presentation time: Sunday, Oct 20, 2013, 12:30 PM - 3:00 PM; P1, N=34; NCT01156870; "SAR 190 mg/m² fulfills the criteria for RD: no DLT and manageable ocular AE versus highest DL. Clinical benefit was observed at doses ≥120 mg/m²: 1 partial response (breast), 1 PR to be confirmed (ovary), 3 stable disease (SD)>6months and 11 SDs were noted. A significant decrease in tumor marker was noted in 1 Pt."

P1 data • Breast Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer

Preclinical activity of an antibody drug conjugate targeting tumor specificmuc1 structural peptide-glycotope (AACR 2019) - "Efficacy was correlated with MUC1-CA6 expression levels. In 3 additional models, SAR566658 showed anti-tumor activity that was more potent when compared to 3 conventional tubulin cytotoxic agents, docetaxel, vinorelbine and vinblastine."

Preclinical