Deciphera Pharmaceuticals (NASDAQ:DCPH) has announced 9-month follow-up data from the Company’s Phase 3 INVICTUS study of QINLOCK in patients with fourth-line and fourth-line plus gastrointestinal stromal tumors (GIST) and intra-patient dose escalation data from the ongoing Phase 1 study of QINLOCK in patients with second-line through fourth-line plus GIST.
Data were presented at the European Society for Medical Oncology Virtual Congress.
As of a March 9, 2020 cutoff date, ~9 months from the data cutoff date for the primary analysis, the median PFS remained at 6.3 months versus 1.0 month in the placebo arm (hazard ratio [HR] was 0.16).
The median OS as of the data cutoff was not reached in the QINLOCK arm versus 6.3 months in the placebo arm with a HR of 0.42, as compared to the median OS at the May 2019 data cutoff for the primary analysis of 15.1 months in the QINLOCK arm versus 6.6 months in the placebo arm with a HR of 0.36.
QINLOCK also demonstrated a confirmed objective response rate of 11.8% versus 0% in the placebo arm.
Safety profile was consistent with the previous primary analysis results, demonstrating that QINLOCK was generally well tolerated.
In the ongoing Phase 1 study of QINLOCK in patients with second-line through fourth-line plus GIST, demonstrated that the patients whose dose escalated to QINLOCK 150 mg BID experienced additional clinically meaningful benefit.
QINLOCK is approved by the U.S. FDA, Health Canada, Australian Therapeutic Goods Administration for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.