Deciphera Pharmaceuticals Inc. (NASDAQ:DCPH) added $12.40 (48%) to $38.31 on Monday after reporting updated data from heavily pretreated patients with gastrointestinal stromal tumors who received the company's DCC-2618 in a Phase I trial. The data were presented Saturday at the American Society of Clinical Oncology (ASCO) meeting in Chicago.
Monday's stock move translated to a gain in the company's market cap of over $400 million.
This year, Deciphera plans to start the Phase III INTRIGUE trial of DCC-2618 as second-line treatment of GIST. The product is also in the Phase III INVICTUS trial in heavily pretreated fourth-line or greater GIST patients.
In the Phase I trial, once-daily oral DCC-2618 dosed at 100 mg or greater for at least one 28-day cycle led to an objective response rate (ORR) of 24% in 25 second-line patients, 24% in 29 third-line patients, and 9% in 91 fourth-line or later patients. The corresponding three-month disease control rates (DCRs) were 79%, 82% and 64%, respectively. DCC-2618 led to an ORR of 15% and a DCR at three months of 70% in all 145 GIST patients.
Last year, Deciphera reported data from 57 evaluable patients in the trial showing that once-daily DCC-2618 dosed at 100 mg or greater led to 12- and 24-week DCRs of 76% and 57%, respectively.
Deciphera filed after market close on Monday to raise $111.7 million through the sale of 3.8 million shares in a follow-on underwritten by J.P. Morgan and Piper Jaffray.
DCC-2618 is a pan-stem cell (SCF) receptor tyrosine kinase (c-Kit; KIT; CD117) and platelet derived growth factor receptor A (PDGFRA; PDGFR2; CD140A) inhibitor.
Sutent sunitinib from Pfizer Inc. (NYSE:PFE) is approved to treat GIST in patients who progressed on or were intolerant to Gleevec imatinib. In a 312-patient Phase III trial in the indication, Sutent led to an ORR of 6.8%.
Stivarga regorafenib from Bayer AG (Xetra:BAYN) is approved to treat locally advanced, unresectable or metastatic GIST in patients previously treated with Gleevec and Sutent. In an analysis of 28 patients with third-line GIST, Stivarga led to ORR of 4% and a DCR of 71.4%.
Sutent is a small molecule that inhibits multiple receptor tyrosine kinases, and Stivarga is a dual acting signal transduction (DAST) inhibitor of multiple kinases.