VOYAGER Phase 3 clinical trial results…

This week Blueprint Pharmaceuticals announced the results of their Voyager trial which compared AYVAKIT™ (avapritinib) with Regorafenib.

The trial did not meet the main aim (or endpoint).

As a result they are proposing:

  1. To continue promoting avapritinib in the United States for the treatment of adults with unresectable or metastatic PDGFRA exon 18 mutated GIST, including PDGFRA D842V mutations. In addition, they will continue to seek regulatory approval of avapritinib for these GIST patients in Europe.
  1. To discontinue clinical development of avapritinib for all other KIT-mutated GIST indications, including second, third and fourth-line treatment. 
  1. GIST patients currently participating in clinical trials or in expanded access programs will be offered the opportunity to continue treatment with avapritinib in collaboration with their treating oncologist.

GIST Cancer UK are very pleased that avapritinib continues to be appraised for PDGFRA exon 18 mutated GIST including D842V mutations. We hope that Blueprint Pharmaceuticals will use the results of the Voyager trial to stimulate further analysis of how this drug can benefit patients with GIST tumours that have other mutations, as a proportion of these patients may benefit from this drug. Currently, we only have limited information from the press release, but hope to have further results over the next few months.

Further information can be found here in the Blueprint Press release

Posted in GIST News.