- Deciphera Pharmaceuticals Inc DCPH stock plunged to a 52-week after announcing disappointing results from the INTRIGUE Phase 3 study of Qinlock in patients with gastrointestinal stromal tumor (GIST) previously treated with Novartis AG's NVS Gleevec (imatinib).
- The study did not meet the primary endpoint of improved progression-free survival (PFS) compared with the standard of care Pfizer Inc's PFE Sutent (sunitinib).
- The full results from the INTRIGUE Phase 3 clinical study will be presented at an upcoming medical meeting.
- In the study, 453 patients were randomized 1:1 to either Qinlock 150 mg once daily or sunitinib 50 mg once daily for four weeks, followed by two weeks without sunitinib.
- The study did not achieve the primary efficacy endpoint of progression-free survival (PFS).
- In patients with a KIT exon 11 primary mutation (n=327), Qinlock demonstrated a median PFS (mPFS) of 8.3 months compared to 7.0 months for the sunitinib arm.
- Although not formally tested due to the rules of the hierarchical testing sequence, in the all patient intent-to-treat (AP) population, Qinlock demonstrated an mPFS of 8.0 months compared to 8.3 months for the sunitinib arm.
- Price Action: DCPH shares are down 71.6% at $10.24 during the premarket session on the last check Friday.
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