{"id":384073,"date":"2020-11-18T09:03:42","date_gmt":"2020-11-18T14:03:42","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=384073"},"modified":"2020-11-18T09:03:42","modified_gmt":"2020-11-18T14:03:42","slug":"cogent-biosciences-announces-final-results-from-plx9486-phase-1-2-study-in-advanced-gist-patients-at-ctos-2020","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/cogent-biosciences-announces-final-results-from-plx9486-phase-1-2-study-in-advanced-gist-patients-at-ctos-2020\/","title":{"rendered":"Cogent Biosciences Announces Final Results from PLX9486 Phase 1\/2 Study in Advanced GIST Patients at CTOS 2020"},"content":{"rendered":"
\n

Majority of patients treated with PLX9486 + sunitinib experienced clinical benefit with a median PFS of 12 months and 20% ORR, including a complete response, in a heavily pre-treated GIST population; 27% of patients remain on therapy out 27-34 months<\/h2>\n

Combination showed no dose limiting toxicities and no maximum tolerated dose was reached<\/h2>\n

Single agent ctDNA analysis supports PLX9486 specificity and demonstrates clinical activity against KIT exon 17 mutation<\/h2>\n

Phase 3 GIST trial initiation planned for 2H 2021<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

\n

\n CAMBRIDGE, Mass.<\/span>, Nov. 18, 2020<\/span> \/PRNewswire\/ — Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the final results from its PLX9486 + sunitinib Phase 1\/2 study in patients with advanced gastrointestinal stromal tumors (GIST). The data will be presented, summarized and discussed in a live oral session on Friday, November 20<\/span>th<\/sup> from 11:30 a.m. to 12:30 p.m. ET<\/span> at the\u00a0Connective Tissue Oncology Society (CTOS) 2020 virtual meeting. <\/p>\n

\n

\n
\n \"(PRNewsfoto\/Cogent
\n <\/a>\n <\/p>\n<\/p><\/div>\n

PLX9486 is a selective tyrosine kinase inhibitor designed to potently inhibit KIT exon 17 mutations, including D816V. Most patients with imatinib-resistant GIST have both primary and secondary KIT mutations, often including secondary mutations on exon 17 and exon 13, making it difficult to achieve broad therapeutic KIT inhibition. These data suggest that treatment with a combination of PLX9486, a type 1 KIT inhibitor with activity against exon 17 mutations, and sunitinib, a type 2 KIT inhibitor with activity against exon 13 mutations, may provide substantial clinical benefit over treatment with type I or type II inhibitors alone.<\/p>\n

“We are pleased to share final results from our Phase 1\/2 trial of PLX9486 + sunitinib and are excited to advance this combination into a Phase 3 GIST trial in the second half of 2021,” said Andrew Robbins<\/span>, President and CEO of Cogent Biosciences. “With a median progression free survival (PFS) of 12 months in a heavily pre-treated population of advanced GIST patients, this combination holds significant promise for these patients with unmet medical need.” <\/p>\n

\n Oral Presentation: <\/b>\n <\/p>\n

Abstract: 3458521 <\/p>\n

\n Title:<\/b>\u00a0The potent and selective kit inhibitor PLX9486 dosed in combination with sunitinib demonstrates promising progression free survival (PFS) in patients with advanced gastrointestinal stromal tumor (GIST): final results of a phase 1\/2 study.<\/p>\n

\n

\n Date:<\/b>\u00a0November 20, 2020<\/p>\n

\n

\n Time:<\/b>\u00a0Session 8: 11:30 a.m. – 12:30 p.m. ET<\/span><\/p>\n

“The final results from this Phase 1\/2 trial are highly encouraging for GIST patients who have limited treatment options due to secondary resistance KIT mutations,” said Jonathan Trent<\/span>, M.D., Ph.D., Associate Director for Clinical Research, Sylvester Comprehensive Cancer Center, University of Miami<\/span> Health System. “I look forward to\u00a0participating in the upcoming trial of\u00a0this promising combination for imatinib-resistant\u00a0GIST patients.”<\/p>\n

\n Results:<\/b>\n <\/p>\n

Out of the 18 patients with advanced GIST enrolled in the trial, all patients had received prior treatment, including 67% of patients with at least three prior lines of therapy. Doses for this study included 3 levels: <\/p>\n