Date: 2015-02-24
Type of information: Completion of patient enrollment
phase: 2
Announcement: completion of patient enrollment
Company: OncoGenex Pharmaceuticals (USA - WA) Sarah Cannon Research Institute (USA - TX)
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: advanced, non-squamous, non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The Spruce clinical trial is a randomized phase II study. It will compare the efficacy and safety of the combination of carboplatin and pemetrexed with and without OGX-427 in patients with previously untreated advanced non-squamous NSCLC. Spruce is sponsored and led by Sarah Cannon Research Institute (SCRI), the research arm of Sarah Cannon, Hospital Corporation of America's (HCA) global cancer enterprise, and is being conducted at 16 sites across the United States. (NCT01829113) Spruce is one of two randomized Phase 2 trials of apatorsen in NSCLC. The CEDAR clinical trial, an investigator-sponsored, randomized, open-label, Phase 2 trial evaluating apatorsen in patients with previously untreated, advanced, squamous cell lung cancer is currently enrolling. Cedar is being conducted and funded primarily by the UK National Cancer Research Network and the UK Experimental Cancer Medicine Network at approximately 20 centers in the United Kingdom.
Latest
news: * On January 20, 2016, OncoGenex Pharmaceuticals announced that data from the Phase 2 Spruce™ trial evaluating the combination of apatorsen with carboplatin and pemetrexed in patients with untreated metastatic non-small cell lung cancer (NSCLC) did not reach the statistical significance required to demonstrate a progression-free survival (PFS) benefit. A potential PFS benefit was observed in patients with high baseline serum Hsp27 status when treated with apatorsen. The study is ongoing and overall survival results are expected in the second half of 2016. Treatment and maintenance therapy with apatorsen was well tolerated. Adverse events were comparable between the arms and as expected for the study chemotherapy treatment. Approximately 155 patients with non-squamous NSCLC received either apatorsen plus carboplatin and pemetrexed therapy or placebo plus carboplatin and pemetrexed therapy in the Spruce trial. In addition to PFS and OS, other analyses are being conducted to evaluate tumor response rates, safety, tolerability, and the effect of therapy on Hsp27 levels. Detailed results will be presented at an upcoming medical meeting. * On February 24, 2015, OncoGenex Pharmaceuticals and Sarah Cannon announced that patient enrollment has been completed in the Spruce™ clinical trial, an investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating apatorsen in combination with carboplatin and pemetrexed in patients with previously untreated, advanced, non-squamous, non-small cell lung cancer (NSCLC). In the Spruce trial, approximately 155 patients were randomized to receive either apatorsen or placebo in combination with carboplatin and pemetrexed therapy. The primary objective of the trial is progression-free survival (PFS), with additional analyses to evaluate overall survival, tumor response rates, safety, tolerability and the effect of therapy on heat shock protein 27 (Hsp27) levels.
