- Deciphera Pharmaceuticals Inc announced an exploratory analysis of data from the INTRIGUE Phase 3 study of Qinlock using circulating tumor DNA (ctDNA).
- The data comes from a subgroup of patients with gastrointestinal stromal tumors (GIST) previously treated with imatinib who harbor mutations in KIT exon 11 and 17/18 only.
- Patients with mutations in KIT exon 11 and exon 17/18 only had substantially improved progression-free survival (PFS), objective response rate (ORR), and overall survival (OS) with Qinlock versus Pfizer Inc's Sutent (sunitinib).
- The median progression-free survival for Qinlock of 14.2 months versus sunitinib of 1.5 months.
- The objective response rate of 44.4% for Qinlock versus 0% for sunitinib.
- The median overall survival for Qinlock was not estimable versus 17.5 months for sunitinib.
- The company plans to initiate the INSIGHT pivotal Phase 3 study of Qinlock versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17/18 only in 2H of 2023.
- Separately, Deciphera posted interim Q4 sales of approximately $36 million and FY22 revenue of approximately $134 million.
- Qinlock net product revenue is estimated to be approximately $33 million.
- A cash balance of $339 million is expected to provide a runway into 2025.
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