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Deciphera sets sights on a second marketed drug

After being stymied in attempts to broaden the use of Qinlock, Deciphera is bidding to add a second string to its bow. Its second marketed drug could be vimseltinib, an oral small molecule specific for CSF-1R that today scored a 40% remission rate by independent review, versus 0% for placebo, in the phase 3 Motion study in tenosynovial giant cell tumour. The company says this cancer has a US prevalence of just 9,000, and is currently treated with Daiichi Sankyo’s CSF-1R/Kit/Flt3 inhibitor Turalio and Novartis’s Bcr-Abl inhibitor Gleevec. 25% of Motion patients had failed prior systemic therapy, so the data look slightly worse than uncontrolled phase 2 results showing 64% and 44% ORRs in CSF-1R-naive and pretreated patients respectively. As for toxicity, 10% of vimseltinib-treated patients in Motion had grade 3/4 creatine phosphokinase increases, while 23% had elevated AST (none above grade 2). Deciphera plans regulatory filings in the second quarter of next year. Meanwhile, Qinlock is stalled in fourth-line GIST, a setting where Blueprint’s Ayvakit failed. But Ayvakit secured an exon 18 mutation-positive GIST label, in addition to other cancers, while Qinlock flunked Intrigue, a second-line GIST trial. Deciphera now wants to expand Qinlock into a genetically defined second-line GIST setting.


Clinical-stage small-molecule CSF-1R inhibitors

ProjectCompanyStatus
Turalio*Daiichi Sankyo (ex Plexxicon)US approved for tenosynovial giant cell tumour
VimseltinibDeciphera PharmaceuticalsORR 40%, vs 0% for placebo, in ph3 Motion trial for tenosynovial giant cell tumour
PimicotinibAbbisko TherapeuticsPh3 Maneuver trial in tenosynovial giant cell tumour
HMPL-653HutchmedPh1 in tenosynovial giant cell tumour
EI-1071Elixiron ImmunotherapeuticsPh1 completed
BLZ945NovartisPh1/2 terminated
ARRY-382Pfizer (ex Array)Ph1/2 terminated
PLX73086Daiichi Sankyo (ex Plexxicon)Ph1 tenosynovial giant cell tumour trial terminated
EdicotinibJohnson & JohnsonPh1 completed in 2013

Note: *also inhibits Kit & Flt3. Source: OncologyPipeline.