Updated NAVIGATOR Trial Results in Patients with Advanced GISTs Support Development of Avapritinib Across Multiple Lines of Therapy
On Thursday, November 15, 2018, Dr. Michael Heinrich from Oregon Health & Science University presented updated results from Blueprint Medicines’ Phase 1 NAVIGATOR trial of avapritinib, an investigational therapy being developed for advanced gastrointestinal tumors (GIST). The data showed that avapritinib was highly active across all lines of therapy for patients with PDGFRα D842V-driven GIST, and in GIST patients treated in second, third and fourth lines, including patients with KIT-driven GIST. In addition, avapritinib was well-tolerated with most safety events reported by clinical investigators as mild (Grade 1) or moderate (Grade 2). These results were presented in an oral presentation at the Connective Tissue Oncology Society 2018 Annual Meeting in Rome, Italy. The press release describing these data can be found here <http://ir.blueprintmedicines.
See Dr Heinrich’s interview with Targeted Oncology here: http://www.gistsupport.org/ask-the-professional/heinrich-discusses-avapritinib/
The updated data from the ongoing NAVIGATOR trial support Blueprint Medicines’ plans to submit a New Drug Application in the first half of 2019 to the U.S. Food and Drug Administration for the treatment of PDGFRA Exon 18 mutant GIST, which primarily includes patients with the D842V mutation, and fourth-line GIST. In addition, these results support Blueprint Medicines’ approach in its ongoing Phase 3 VOYAGER trial <http://www.voyagertrial.com/>
As of the data cutoff date of October 15, 2018, 231 patients were treated with avapritinib in the Phase 1 NAVIGATOR clinical trial. Treatment with avapritinib was well-tolerated. Across all doses, 20 patients (8.7 percent) discontinued therapy with avapritinib due to treatment-related safety events. The reported data included:
In PDGFRα D842V-driven GIST (56 evaluable patients), the objective response rate (ORR) was 84 percent and 76 percent of patients achieved a 12-month duration of response.
In fourth-line or later GIST (109 evaluable patients), the ORR was 20 percent and the median duration of response was 7.3 months.
Patients and physicians interested in GIST clinical trials can contact the Blueprint Medicines study director at studydirector@blueprintmedicin