Blueprint Medicines Corp BPMC shares were taking a beating Tuesday after the company announced a negative late-stage readout for its lead asset avapritinib in third- or fourth-line gastrointestinal stromal tumors.
Blueprint's Study Results Study Force Discontinuation
Top-line results from a Phase 3 trial dubbed VOYAGER that evaluated avapritinib versus Bayer AG's BAYRY regorafenib as an active comparator showed that study did not meet the primary endpoint of an improvement in progression-free survival, the Cambridge, Massachusetts-based company said in a statement.
The safety data was consistent with previous reports, according to Blueprint.
Following the adverse readout, Blueprint said it plans to discontinue further development of avapritinib in GIST beyond PDGFRA exon 18 mutant GIST.
Incidentally, the FDA had given a new PDUFA action date of May 14 for the drug in third- and fourth-line GST following a three-month extension from the original deadline of Feb. 14, as it wanted the comparator data before making a decision.
Blueprint said it will continue to commercialize avapritinib, which is marketed under the brand name Ayvakit in the U.S., for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.
It also plans to seek marketing approval for the drug for the indication in other geographies. A decision for the indication is expected from the European Commission in the third quarter.
Deciphera's Sympathy Move
Reacting to Blueprint's data, Deciphera Pharmaceuticals Inc DCPH shares were spiking higher in sympathy. The company's lead asset ripretinib, a broad -spectrum inhibitor of KIT and PDGFR-alpha, is being evaluated in GIST in fourth-line settings and above. The company has submitted an NDA to the FDA, with the regulatory agency due to announce its verdict by the Aug. 13 PDUFA action date.
Deciphera also announced it will release its first-quarter results May 5 after the market closes.
BMPC, DCPH Price Action
At last check, Blueprint shares were sliding 19.72% to $56.92, while Deciphera shares were rising 16.12% to $56.20.
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