ARIAD reports the Iclusig Phase 2 data in adult patients with gastrointestinal stromal tumors -
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) announced today, for the first time, data from its phase 2 trial of Iclusig ® (ponatinib) in adult patients with refractory metastatic and / or gastrointestinal stromal tumors (GIST inoperable). Early data show that ponatinib has anti-tumor activity in patients with advanced GIST, particularly in patients with KIT exon 11 mutations after failure of at least one prior tyrosine kinase inhibitor (TKI). The primary endpoint of the trial, the clinical benefit rate (CBR) at 16 weeks for patients with KIT exon 11 mutations was 50 percent, with a median follow up of six months.
These data are being presented today in an oral presentation at 10:00 CT at the annual meeting of the American Society of Clinical Oncology (ASCO) meeting in Chicago.
Phase 2 of ponatinib in GIST enrolled 35 patients of April 7, 2014. The trial is ongoing, and the partial clinical hold FDA for recruiting new patients was lifted. The population of patients in the trial is heavily pretreated, with 46 percent having failed three ITK GIST approved before. Patients were enrolled into two cohorts based on the presence (cohort A) or absence (cohort B) of KIT exon 11 mutations. Primary KIT mutations occur in approximately 85 percent of patients with GIST. The most common mutation is in exon 11 (~ 70 percent). Pre-clinically, ponatinib showed a convincing activity against the activation of exon 11 mutations.
"These early data confirm the preclinical findings that Ponatinib has activity against mutations in KIT acquired whose GIST patients may develop following treatment with other targeted TKIs," said Michael C. Heinrich, MD, Professor of medicine and cell / developmental biology at the Knight cancer Institute, Oregon Health & science University, Portland, Oregon. "The treatment with approved agents in the second or third line parameters is associated with a median time to progression of less than six months for each processing line. There is a large unmet need for additional treatments for this patient population. Stable disease at 16 weeks is an important step for refractory patients, so I believe that these early clinical responses to ponatinib are encouraging. "
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