Date: 2015-09-23
Type of information: Results
phase: 2
Announcement: results
Company: OncoGenex Pharmaceuticals (USA - WA)
Product: apatorsen (OGX-427)
Action
mechanism: antisense oligonucleotide/heat shock protein inhibitor. Heat shock protein 27 (Hsp27) is an intracellular protein that protects cancer cells by helping them survive, leading to treatment resistance and more aggressive cancer phenotypes. Expression of Hsp27 is limited in normal cells but is elevated in many types of cancer cells making Hsp27 an attractive therapeutic target for cancer treatment. Apatorsen is a once-weekly intravenous (IV) experimental drug designed to inhibit production of Hsp27 to disable cancer cells’ defenses and overcome treatment resistance.
Disease: pancreatic cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This randomized, double-blinded, placebo-controlled phase II trial compares the overall survival in patients with previously untreated metastatic pancreatic cancer receiving gemcitabine/nab-paclitaxel plus OGX-427 or gemcitabine/nab-paclitaxel plus placebo. (NCT01844817)
Latest
news: *On September 23, 2015, OncoGenex Pharmaceuticals announced initial results from the Phase 2 Rainier™ study evaluating apatorsen in combination with Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) and gemcitabine compared to Abraxane® and gemcitabine alone in patients with untreated metastatic pancreatic cancer. The addition of apatorsen to Abraxane® and gemcitabine did not demonstrate a survival benefit compared to Abraxane® and gemcitabine alone. The study was sponsored and conducted by Sarah Cannon Research Institute (SCRI) and further results will be presented by SCRI at a future medical meeting.
The most common grade 3/4 treatment-related toxicities on the apatorsen arm were anemia, neutropenia and fatigue, also consistent with the chemotherapy regimen side effects. These and other adverse events (AEs) observed on the apatorsen arm were similar to those seen in previous trials, with the exception of an increase in grade 4 or greater AEs and serious AEs in this pancreatic cancer trial. While patients in the apatorsen arm had fewer treatment discontinuations due to progressive disease, more patients discontinued therapy due to AEs.
