Deciphera Pharmaceuticals, Inc.
’s
DCPH
sole marketed drug, Qinlock, is approved for the treatment of adult patients with advanced gastrointestinal stromal tumors (“GIST”) who have received prior treatment with three or more kinase inhibitors, including
Novartis
’
NVS
Gleevec (imatinib). The initial uptake of the drug has been strong since its approval in May 2020.
The company submitted and received validation of a marketing authorization application for Qinlock in fourth-line GIST from the EMA. In September 2021, the EMA’s Committee for Medicinal Products for Human Use rendered a positive opinion, recommending approval for Qinlock to treat the given indication. A potential EMA approval is expected later in 2021.
Deciphera is also working to expand the label of Qinlock in second-line GIST. A phase III study — INTRIGUE —is comparing Qinlock to
Pfizer
’s
PFE
Sutent (sunitinib) in patients with second-line GIST. Top-line results from this study are expected later in the ongoing year. The company also plans to initiate a phase I/IIb study of Qinlock in combination with Mektovi (binimetinib), an approved MEK inhibitor, to address post-imatinib GIST patients in fourth-quarter 2021. Potential label expansion of the drug can boost sales and drive growth in the days ahead.
Deciphera has a diverse pipeline, and is advancing multiple drug candidates in various stages of clinical development. The company is evaluating vimseltinib for the potential treatment of tenosynovial giant cell tumor. The company is also developing rebastinib, which is being studied in two phase Ib/II studies in combination with chemotherapy.
Deciphera is evaluating its investigational ULK kinase inhibitor, DCC-3116, in a phase I study, to treat patients with advanced/metastatic tumors driven by mutations in RAS/RAF genes. The study is investigating DCC-3116 as a single agent and also in combination with Mekinist (trametinib), an FDA-approved MEK inhibitor.
We note that Deciphera currently has only one approved product in its portfolio — Qinlock. This apart, all of its drug candidates, including vimseltinib, rebastinib and DCC-3116, are still in early stages of development. Hence, any regulatory setback for the candidates will be a setback for the company. Qinlock faces competition from
Blueprint Medicines
’
BPMC
Ayvakit, which is approved for the treatment of unresectable or metastatic GIST, harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations in adults. Several other companies are also developing drugs for the treatment of GIST. This too remains an overhang.
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