Date: 2015-06-01
Type of information: Results
phase:
Announcement: results
Company: Immunomedics (USA - NJ)
Product: sacituzumab govitecan - IMMU-132
Action
mechanism: antibody drug conjugate/ADC. Sacituzumab govitecan, or IMMU-132, is a first-in-class ADC developed by Immunomedics by conjugating the moderately-toxic drug, SN-38 (active metabolite of irinotecan), site-specifically and at a high ratio of drug to antibody, to a humanized antibody that targets the TROP-2 receptor expressed by many solid cancers. SN-38 is the active metabolite of irinotecan (Camptosar), which is used to treat certain solid cancers as a part of combination therapies, so its pharmacology and properties are well-known. IMMU-132 targets the TROP-2 antigen which is expressed on a variety of cancers. The ADC has received Fast Track designation from the FDA for the treatment of patients with triple-negative breast cancer, small-cell and non-small-cell lung cancers, and has also been designated an orphan drug for the treatment of patients with small-cell lung or pancreatic cancer in the U.S., and for the treatment of patients with pancreatic cancer in the European Union.
Disease: metastatic gastrointestinal cancers
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On June 1, 2015, Immunomedics announced that a majority of patients with heavily-pretreated, metastatic gastrointestinal cancers responded to sacituzumab govitecan, the Company’s first-in-class antibody-drug conjugate (ADC), with partial responses and durable stable disease in a mid-stage clinical study. A total of 65 patients with various types of gastrointestinal cancers had been enrolled into this multicenter study to receive sacituzumab govitecan weekly for the first 2 weeks of a 3-week cycle. At the time of analysis, 60 patients had at least one post-treatment evaluation for response by computed tomography according to rules set by the Response Evaluation Criteria In Solid Tumors (RECIST 1.1). Despite the late-stage setting, the overall disease control rate (partial response + stable disease) for all 60 assessable patients was 57%, including 2 esophageal cancer patients and 1 colorectal cancer patient with a partial response. While patient follow-up is continuing, interim analysis of survival data revealed a favorable outcome in both progression-free survival (PFS) and overall survival (OS).
Sacituzumab govitecan continues to show an acceptable safety profile in these patients with diverse, advanced, heavily-pretreated solid cancers. Grades 3 and 4 adverse events at the doses of 8 and 10 mg/kg include dose-limiting neutropenia (30%), followed by febrile neutropenia (8%), and diarrhea (6%).
