USA-based tumor drug resistance specialist Deciphera Pharmaceuticals (Nasdaq: DCPH) saw its shares plummet more than 74% to $9.21 on Friday, after it announced top-line results from the INTRIGUE Phase III clinical study of Qinlock (ripretinib) in patients with gastrointestinal stromal tumor (GIST) previously treated with imatinib, which did not meet the primary endpoint of improved progression-free survival (PFS) compared with the standard of care sunitinib.
“While we are disappointed with these results, which we learned yesterday, we believe this was a robust, well-designed, and well-executed study. The full results from the INTRIGUE Phase III clinical study are expected to be presented at an upcoming medical meeting,” said Steve Hoerter, president and chief executive of Deciphera, adding: “Qinlock remains the standard of care and only approved therapy in patients with fourth-line GIST, and we are committed to ensuring that patients around the world in the fourth-line GIST treatment setting have access to Qinlock.”
Qinlock was approved for the treatment of GIST by the US Food and Drug Administration in May 2020 and has been cleared for marketing in several other countries. It was recommended for approval by the European Medicines Agency in September this year. Qinlock, Deciphera’s only marketed product, recorded $21.7 million net product revenue in the third quarter of 2021, including $20.0 million in US sales.
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