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Avapritinib Versus Regorafenib in Locally Advanced Unresectable or Metastatic GI Stromal Tumor: A Randomized, Open-Label Phase III Study. | LitMetric

AI Article Synopsis

  • The study aims to assess the efficacy of avapritinib, a drug targeting specific mutations in gastrointestinal stromal tumors (GISTs), compared to regorafenib in patients with advanced GISTs.
  • In a randomized trial called VOYAGER, patients were assigned to receive either avapritinib or regorafenib, with primary outcomes focused on progression-free survival (PFS) and secondary measures including overall survival and response rates.
  • Results showed similar median PFS between the two drugs, with avapritinib having a higher objective response rate but overall survival data being immature at the time of analysis, leading to the conclusion that the primary endpoint was not met.

Article Abstract

Purpose: Primary or secondary mutations in or platelet-derived growth factor receptor alpha () underlie tyrosine kinase inhibitor resistance in most GI stromal tumors (GISTs). Avapritinib selectively and potently inhibits KIT- and PDGFRA-mutant kinases. In the phase I NAVIGATOR study (NCT02508532), avapritinib showed clinical activity against PDGFRA D842V-mutant and later-line KIT-mutant GIST. VOYAGER (NCT03465722), a phase III study, evaluated efficacy and safety of avapritinib versus regorafenib as third-line or later treatment in patients with unresectable or metastatic GIST.

Patients And Methods: VOYAGER randomly assigned patients 1:1 to avapritinib 300 mg once daily (4 weeks continuously) or regorafenib 160 mg once daily (3 weeks on and 1 week off). Primary end point was progression-free survival (PFS) by central radiology per RECIST version 1.1 modified for GIST. Secondary end points included objective response rate, overall survival, safety, disease control rate, and duration of response. Regorafenib to avapritinib crossover was permitted upon centrally confirmed disease progression.

Results: Four hundred seventy-six patients were randomly assigned (avapritinib, n = 240; regorafenib, n = 236). Median PFS was not statistically different between avapritinib and regorafenib (hazard ratio, 1.25; 95% CI, 0.99 to 1.57; 4.2 5.6 months; = .055). Overall survival data were immature at cutoff. Objective response rates were 17.1% and 7.2%, with durations of responses of 7.6 and 9.4 months for avapritinib and regorafenib; disease control rates were 41.7% (95% CI, 35.4 to 48.2) and 46.2% (95% CI, 39.7 to 52.8). Treatment-related adverse events (any grade, grade ≥ 3) were similar for avapritinib (92.5% and 55.2%) and regorafenib (96.2% and 57.7%).

Conclusion: Primary end point was not met. There was no significant difference in median PFS between avapritinib and regorafenib in patients with molecularly unselected, late-line GIST.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8478403PMC
http://dx.doi.org/10.1200/JCO.21.00217DOI Listing

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