Date: 2016-06-06
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
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 small-cell lung cancer (SCLC)
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On June 6, 2016, Immunomedics reported an overall response rate of 24% (8/33) in assessable patients with metastatic small-cell lung cancer (SCLC) after receiving treatment with sacituzumab govitecan, at the dose level of 8 mg/kg or 10 mg/kg. Three of the eight partial responders (PRs) have been confirmed with a follow-up computed tomography scan, to yield a confirmed response rate of 9%. The remaining five initial responders had progressive disease at the confirmatory scan.
Including the 11 patients with stable disease, the median duration of response for the 19 patients who responded to sacituzumab govitecan was an encouraging 3.8 months, with six patients still receiving treatment. Median progression-free survival for the 36 intent-to-treat patients was 3.6 months (83% maturity), and median overall survival was 8.1 months (50% maturity). Alexander N. Starodub, MD, PhD, Medical Oncologist at IU Health Center for Cancer Care in Goshen, Indiana, presented the Phase 2 study at the 2016 Annual Meeting of the American Society of Clinical Oncology (ASCO).
As of February 11, 2016, a total of 36 patients with metastatic SCLC had been enrolled into the open-label study to receive sacituzumab govitecan at 8 mg/kg (N=15) or 10 mg/kg (N=21). Median number of prior chemotherapies for this group of patients was 2 (range, 1-5). All patients had previous treatment with platinum-based therapy and etoposide, and 11 had received topotecan. Main toxicities reported by Dr. Starodub were neutropenia (34%), diarrhea (11%) and leukopenia (9%). However, no prophylactic diarrhea or granulocyte colony-stimulating
factor (G-CSF) medication to stimulate the production of neutrophils was given.
As with all other solid cancer types studied in this trial with sacituzumab govitecan, these SCLC patients were administered the ADC on days 1 and 8 of 21-day treatment cycles. Treatment continues based on tolerance or until progression, with safety and response assessments (RECIST 1.1) with computed tomography (CT) made every week and at 8-12 weeks, respectively. Despite repeated dosing, no patient developed antibodies to the antibody or the drug, SN-38.
