Date: 2015-01-27
Type of information: Results
phase: 3
Announcement: results
Company: Pfizer (USA - NY)
Product: PF-00299804 - dacomitinib
Action
mechanism: tyrosine kinase inhibitor. Dacomitinib is an irreversible inhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosine kinases.
Disease: advanced non-small cell lung cancer
Therapeutic area: Cancer - Oncology
Country: ARCHER 1009 : Austria, Belgium, China, Denmark, Finland, France, Germany, Greece,Hungary, India, Ireland, Japan, Republic of Korea, Mexico, Poland, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, UK, USA - BR.26 : Argentina,Australia,Brazil, Canada, Italy, Republic of Korea,New Zealand, Peru, Philippines,Taiwan,Thailand, USA
Trial
details: The ARCHER 1009 trial evaluated dacomitinib versus erlotinib in two co-primary populations of patients with advanced NSCLC previously treated with at least one chemotherapy regimen – all patients and patients with KRAS wild-type NSCLC (NCT01360554). The BR.26 trial was a double-blind, placebo-controlled, randomized study evaluating dacomitinib in patients with locally advanced or metastatic NSCLC after prior treatment, which included at least one chemotherapy regimen and one EGFR inhibitor treatment regimen. This study was designed, conducted and led by NCIC Clinical Trials Group (NCIC CTG). (NCT01000025)
Latest
news: * On January 27, 2014, Pfizer announced top-line results from two randomized Phase 3 studies of the irreversible pan-HER kinase inhibitor dacomitinib in patients with advanced non-small cell lung cancer (NSCLC). Both trials evaluated dacomitinib in populations of previously treated patients with advanced NSCLC. The ARCHER 1009 trial, which included patients previously treated with chemotherapy (second/third line), did not meet its objective of demonstrating statistically significant improvement in progression-free survival (PFS) when compared with the EGFR inhibitor erlotinib. Separately, the NCIC CTG BR.26 trial, which included patients with advanced NSCLC after standard therapy with both chemotherapy and an EGFR tyrosine kinase inhibitor had failed, did not meet its objective of prolonging overall survival (OS) versus placebo.In both studies, the adverse events observed for dacomitinib generally were consistent with its known adverse event profile. Full efficacy and safety data from ARCHER 1009 and BR.26 will be submitted for presentation at an upcoming medical meeting. An ongoing, third Phase 3 trial, ARCHER 1050, is evaluating PFS of dacomitinib in a different patient population than was studied in ARCHER 1009 and BR26. ARCHER 1050 compares dacomitinib versus gefitinib in treatment-naïve (without prior treatment) patients with EGFR-mutant advanced NSCLC. The results are expected in 2015.
