{"id":17079,"date":"2022-04-18T16:40:33","date_gmt":"2022-04-18T11:10:33","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=17079"},"modified":"2022-04-18T17:19:31","modified_gmt":"2022-04-18T11:49:31","slug":"aacr-2022-krasg12c-novartis","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/aacr-2022-krasg12c-novartis","title":{"rendered":"AACR 2022: Novartis shifting focus towards directly targeting KRASG12c after disappointment from SHP2 inhibitor, TNO155."},"content":{"rendered":"\n<h2 class=\"wp-block-heading\" id=\"h-post-lumakras-approval-adagrasib-s-pdufa-date-novartis-now-ready-to-enter-the-krasg12c-space\"><strong>Post Lumakras \u2018approval,\u00a0 Adagrasib\u2019s PDUFA date, Novartis now ready to enter the KRASG12C space<\/strong><\/h2>\n\n\n\n<p>Novartis is now heading towards its unique KRASG12C inhibitor in patients with advanced non-small cell lung cancer (NSCLC).<strong><em> <\/em><\/strong>The company presented the promising preliminary data (Phase Ib) from the <strong>KontRASt-01 study <\/strong>evaluating <strong>JDQ443<\/strong> in patients with advanced NSCLC. The results reported that at the median duration of 15.9 weeks, the confirmed <strong>overall response rate<\/strong> (ORR) at RP2D 200 mg was <strong>57%<\/strong>, which somehow demonstrated the <strong>early efficacy signals<\/strong> and a tolerable safety profile from the dose-escalation portion of the Phase Ib\/II KontRASt-01 trial. In terms of a safety point of view, the maximum tolerated dose was <strong>not reached<\/strong> at the time of the data cut off (January 5, 2021,). The <strong>TRAEs <\/strong>occurred in <strong>71.8%<\/strong> of patients which included 4 grade 3 TRAEs. <strong><em><\/em><\/strong><\/p>\n\n\n\n<p><em>The promising early data of the <strong>KontRASt-01 study<\/strong> demonstrated high systemic exposure at the recommended dose of 200 mg with a favorable safety profile. The results of the KontRASt-01 study may improve the outcomes of patients with KRAS G12C-driven cancers and bring a new ray of hope to <a href=\"https:\/\/www.delveinsight.com\/report-store\/non-small-cell-lung-carcinoma-nsclc-epidemiology-forecast\">patients with advanced NSCLC<\/a> in terms of survival benefits.<\/em><\/p>\n\n\n\n<p><em>Additionally, the competitors in KRASG12C mutation space also involves <strong>Mirati\u2019s<\/strong> <strong>Adagrasib<\/strong> (close to getting its approval as the PDUFA date is December 14, 2022) and <strong>Amgen\u2019s Lumakras <\/strong>(already in the market). Surprisingly, <strong>JDQ443 <\/strong>(57% confirmed ORR), on a cross-study basis seemed to be on par with both its competitors with:<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong><em>36% ORR <\/em><\/strong><em>of<strong> Lumakras <\/strong>in G12C-mutant NSCLC (Codebreak-100 trial), and<\/em><\/li><li><em>&nbsp;<strong>45% ORR<\/strong> of the next most-advanced KRAS inhibitor, <strong>Mirati\u2019s adagrasib<\/strong> (Krystal-1 trial)<\/em><\/li><\/ul>\n\n\n\n<p><em>Infact, on the safety front too, JDQ443 is leading, with the least number of patients suffering from severe adverse events, although in a very small sample size.<\/em><\/p>\n\n\n\n<p><em>Moving on to assessing these <a href=\"https:\/\/www.delveinsight.com\/report-store\/colorectal-cancer-crc-pipeline-insight\">drugs for KRASG12 C mutation in <strong>colorectal cancer<\/strong><\/a><strong> <\/strong>patients, Adagrasib is leading with <strong>22% ORR<\/strong>, Lumakras has shown lower efficacy and JDQ443 has data on a very limited sample. Focusing on NSCLC, Novartis is all set to start a Phase III trial in mid-2022 (JDQ443 vs Docetaxel) and we now await to see the challenges Novartis faces if there are no plan for a head to head comparison against Lumakras.&nbsp;Moreover, we also look forward to SHP-2 inhibitor as a part of combination trials in future, considering its failure as a monotherapy.<\/em><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Increase response rate of Lumkaras<\/strong><\/h2>\n\n\n\n<p><strong>Amgen<\/strong> presented the promising long-term efficacy and safety data from the <strong>CodeBreaK<\/strong> 100 Phase I\/II trial in patients with KRAS G12C-mutated advanced NSCLC who received Lumakras. The results demonstrated an overall survival rate of <strong>32.5%<\/strong> at 2 years in patients with KRAS G12C\u2013mutant NSCLC. The ORR achieved was <strong>40.7%<\/strong> and the disease control rate (DCR) was <strong>83.7%<\/strong>. Additionally, the median duration of response (DOR) was <strong>12.3 months<\/strong> followed by the median progression-free survival (PFS) that was <strong>6.3 months<\/strong> and the median OS was <strong>12.5 months<\/strong>. Moreover, long-term treatment did not raise any new safety concerns. The Treatment-related adverse effects (TRAEs) of grade 3\/4 occurred in <strong>21%<\/strong> of patients, with one patient developing a new-onset grade 3 TRAE of hemolytic anemia after one year.<\/p>\n\n\n\n<p><em>The impressive findings from the Lumakras study demonstrated that since the FDA approval of Lumakras, the treatment paradigm for patients with advanced non-small cell lung cancer who harbor the KRAS G12C mutation has now begin to change. We so believe that the durable efficacy and positive benefit-risk profile seen in the two-year analysis of CodeBreaK 100 highlight the important role of this innovative targeted therapy. Considering that Lumakras is the first-ever KRASG12C approved, we look forward to its market positioning post the entry of Adagrasib in late 2022 or early 2023, followed by Novartis\u2019 DQ443.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Post Lumakras \u2018approval,\u00a0 Adagrasib\u2019s PDUFA date, Novartis now ready to enter the KRASG12C space Novartis is now heading towards its unique KRASG12C inhibitor in patients with advanced non-small cell lung cancer (NSCLC). The company presented the promising preliminary data (Phase Ib) from the KontRASt-01 study evaluating JDQ443 in patients with advanced NSCLC. The results reported [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":17080,"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":[41],"tags":[3057,19245,17026,427],"industry":[17225],"therapeutic_areas":[17228],"class_list":["post-17079","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-snippets","tag-aacr","tag-aacr-2022","tag-kras-inhibitors","tag-oncology","industry-pharmaceutical","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>AACR 2022 | KRAS Data 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