{"id":27546,"date":"2024-04-09T16:25:13","date_gmt":"2024-04-09T10:55:13","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=27546"},"modified":"2024-04-10T09:06:31","modified_gmt":"2024-04-10T03:36:31","slug":"adagrasib-krystal1-phase-i-ii-results","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/adagrasib-krystal1-phase-i-ii-results","title":{"rendered":"KRYSTAL-1: A pooled phase 1\/2 efficacy and safety of adagrasib (MRTX849) in combination with cetuximab in patients with metastatic colorectal cancer (CRC) harboring a KRASG12C mutation"},"content":{"rendered":"\n<p>Adagrasib is an irreversible KRAS G12C inhibitor that is designed to have a 23-hour half-life, dose-dependent pharmacokinetics, and central nervous system penetration. The pooled analysis of Phase I\/II (KRYSTAL-1) trial that was presented during the AACR 2024 conference demonstrated that, as of the data cutoff date of <strong>June 30, 2023,<\/strong> and a median follow-up of 11.9 months, the ORR achieved by the combination as per blinded independent central review (BICR) was 34.0% and the disease control rate was 85.1%. Moreover, the median duration of response (DOR) was 5.8 months. Further findings showed that the median PFS was 6.9 months and the 6-month PFS rate was 57.7%. The median OS was 15.9 months and the 6-month OS rate was 87.8%.<\/p>\n\n\n\n<p>Regarding safety, all patients experienced any grade treatment-related adverse effects (TRAEs), and most were grade 2 (63.8%). The most frequent TRAEs were nausea (any-grade, 60.6%; grade 3, 2.1%), vomiting (51.5%; 0%), diarrhea (48.9%; 1.1%), dermatitis acneiform (47.9%; 2.1%), fatigue (42.6%; 1.1%), dry skin (34.0%; 0%), hypomagnesemia (28.7%; 2.1%; grade 4, 1.1%), headache (26.6%; 3.2%), and rash (22.3%; 2.1%).<\/p>\n\n\n\n<p>The National Comprehensive Cancer Network\u2019s Clinical Practice Guidelines in Oncology currently recommend adagrasib plus cetuximab or panitumumab (Vectibix) for use in patients with previously treated KRAS G12C\u2013mutant CRC.<\/p>\n\n\n\n<p>Most importantly, in <strong>February 2024,<\/strong> the US FDA accepted a supplemental new drug application for priority review regarding the approval of adagrasib plus cetuximab for this population, based on the KRYSTAL-1 findings<strong>. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024.<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-kol-insight\"><strong>KOL insight<\/strong><\/h2>\n\n\n\n<p>\u201cAdagrasib and cetuximab demonstrated clinically meaningful activity\u2026in these patients, and the safety profile was consistent with what was previously known.\u201d<strong> \u2013Expert Opinion.<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"304\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/04\/10090623\/Mutation-specific-Distribution-of-Metastatic-CRC-in-the-United-States-1024x304.png\" alt=\"Mutation-specific Distribution of Metastatic CRC in the United States\" class=\"wp-image-27549\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/04\/10090623\/Mutation-specific-Distribution-of-Metastatic-CRC-in-the-United-States-1024x304.png 1024w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/04\/10090623\/Mutation-specific-Distribution-of-Metastatic-CRC-in-the-United-States-300x89.png 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/04\/10090623\/Mutation-specific-Distribution-of-Metastatic-CRC-in-the-United-States-150x45.png 150w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/04\/10090623\/Mutation-specific-Distribution-of-Metastatic-CRC-in-the-United-States-768x228.png 768w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/04\/10090623\/Mutation-specific-Distribution-of-Metastatic-CRC-in-the-United-States-1536x456.png 1536w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/04\/10090623\/Mutation-specific-Distribution-of-Metastatic-CRC-in-the-United-States-2048x608.png 2048w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/04\/10090623\/Mutation-specific-Distribution-of-Metastatic-CRC-in-the-United-States-1568x466.png 1568w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-conclusion\"><strong>Conclusion<\/strong><\/h2>\n\n\n\n<p>Adagrasib and cetuximab combination exhibited promising effectiveness and a tolerable safety profile in patients previously treated for KRAS G12C\u2013mCRC. These results advocate for adagrasib and cetuximab as a prospective new standard of care (SOC) for individuals with previously treated metastatic KRAS G12C [\u2013mutant] colorectal cancer, potentially influencing regulatory considerations for a revised SOC.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Adagrasib is an irreversible KRAS G12C inhibitor that is designed to have a 23-hour half-life, dose-dependent pharmacokinetics, and central nervous system penetration. The pooled analysis of Phase I\/II (KRYSTAL-1) trial that was presented during the AACR 2024 conference demonstrated that, as of the data cutoff date of June 30, 2023, and a median follow-up of [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17126],"tags":[3057,22035,20587],"industry":[17225],"therapeutic_areas":[17228],"class_list":["post-27546","post","type-post","status-publish","format-standard","hentry","category-others","tag-aacr","tag-aacr-2024","tag-aacr-conference","industry-pharmaceutical","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast 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