RebmAb 100 / Recepta - LARVOL DELTA

Anti-LeY monoclonal antibody (mAb) hu3S193 as consolidation therapy for patients (pts) with relapsing platinum sensitive ovarian cancer (OC) after achieving a second complete response (2CR). (ASCO 2017) - P2; "...Median age: 55 yrs (range 29-67); Median KPS: 90% (range 80-100); LeY expression by IHC (N): strong (20), weak (9); stage at initial diagnosis: I/II (2), III/IV (27); median CA-125 prior to 2CR chemoRx: 104 (range 9-514); chemoRx agents to achieve 2CR: paclitaxel/platin (21), liposomal doxo/carboplatin (8); median cycles of prior chemoRx to achieve a 2CR:6; median doses of hu3S193 delivered: 10 (range 10-12)... Despite the good tolerance and the longer PFS compared to historical control, this trial did not show a significant improvement with hu3S193 as a consolidative strategy in patients with 2CR in platinum-sensitive OC. Tumor molecular analysis of patients with long PFS may provide insight for future studies."

Biomarker • Clinical • Biosimilar • Immunology • Ovarian Cancer

Phase II trial of humanized anti-Lewis Y monoclonal antibody for advanced hormone receptor-positive breast cancer that progressed following endocrine therapy. (PubMed, Clinics (Sao Paulo)) - P2 | "The humanized anti-Lewis Y monoclonal antibody, hu3S193, exhibited insufficient activity in this cohort. However, the possibility of activity in a more strictly selected subgroup of patients with higher levels of Lewis Y tumoral expression cannot be overlooked."

Journal • P2 data • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Monoclonal Antibody Therapy in Treating Patients Scheduled for Surgery to Remove Ovarian Cancer (clinicaltrials.gov) - P1; N=1; Terminated; Sponsor: Ludwig Institute for Cancer Research; Completed ➔ Terminated; low study accrual

Clinical • Trial termination • Oncology • Ovarian Cancer • Solid Tumor

Phase II consolidation trial with anti-Lewis-Y monoclonal antibody (hu3S193) in platinum-sensitive ovarian cancer after a second remission. (PubMed, Int J Gynecol Cancer) - P2 | "Hu3S193 did not show sufficient clinical activity as consolidation therapy in patients with recurrent epithelial ovarian cancer who achieved a second complete response after platinum-based chemotherapy."

Clinical • Journal • P2 data • Oncology • Ovarian Cancer • Solid Tumor

HumanaH - Hu3s193 in the Treatment of Advanced Breast Cancer After Hormonal Therapy (clinicaltrials.gov) - P2; N=60; Suspended; Sponsor: Instituto do Cancer do Estado de São Paulo; Recruiting ➔ Suspended

Trial suspension • Biosimilar • Breast Cancer • Oncology • Triple Negative Breast Cancer

HumanaH - Hu3s193 in the Treatment of Advanced Breast Cancer After Hormonal Therapy (clinicaltrials.gov) - P2; N=23; Terminated; Sponsor: Instituto do Cancer do Estado de São Paulo; N=60 ➔ 23; Suspended ➔ Terminated; futility

Clinical • Enrollment change • Trial termination