2020Springer Healthcare is part of the Springer Nature Group. Joaquim Bellmunt, MD. Clinical Care Options, LLC Encouraging efficacy results from Phase III CodeBreak200 (NCT04303780) study demonstrate the effectiveness of Lumakras (sotorasib) in KRAS G12C mutated NSCLC where it currently leads with the only approval which in turn threatens the Miratis accelerated approval for its lead drug candidate Adagrasib. After the median follow-up of 17.7 months, the 12-month PFS rate was 24.8% vs. 10.1% with LUMAKRAS vs. docetaxel docetaxel. Amgen announced that the global Phase III CodeBreaK 200 trial evaluating once daily oral Lumakras (sotorasib) met its primary endpoint of progression-free survival (PFS), demonstrating statistical significance and superiority over standard of care chemotherapy, intravenous docetaxel . Medical writing support was provided by Liz Leight (Amgen Inc.). Gastrointestinal Tumours, Lower Digestive, Gastrointestinal Tumours, Upper Digestive, Non-Metastatic NSCLC and Other Thoracic Malignancies, Targeting HER2 in Advanced Breast Cancer: Successes and Perspectives, Optimising Outcomes of Patients with Advanced Renal Cancer, The Practice and Promise of NGS Tissue Testing for Tumour-Agnostic Precision Therapeutics, Sotorasib improves PFS versus docetaxel in patients with pre-treated KRAS G12C-mutated NSCLC. Updated results of the Phase III, DeFi trial of nirogacestat, an investigational oral gamma secretase inhibitor, demonstrated excellent efficacy and safety profiles, and met endpoints, in adult patients with progressing desmoid tumors. Results from the first-in-human trial of sotorasib (CodeBreak 100, NCT03600883) demonstrated a favorable safety profile and promising and durable antitumor activity in patients with KRAS p.G12C mutant advanced NSCLC. K. Park: Advisory/Consultancy: Amgen. Patients with active brain metastases were excluded from the study. The median PFS was 5.6 months vs. 4.5 months (Hazard Ratio: 0.66 [95% CI: 0.51, 0.86]). Sotorasib is a first-in-class small molecule that specifically and irreversibly inhibits KRASG12C by locking it in its inactive GDP-bound state. . All funding for this site is provided directly by ESMO. Disclaimer: The materials published on the Clinical Care Options Sites reflect the views of the reviewers or authors of the CCO material, not those of Clinical Care Options, LLC, the accredited provider, or the companies providing educational grants. ESMO 2022 is wrapped and two studies in particular have caught our eyes: NICHE-2: neoadjuvant Nivo/Ipi in MMR . Suite 300 Stream ESMO 2022 - NICHE-2 and Codebreak 200 by OncoPharmPod on desktop and mobile. Eligible patients have previously undergone treatment for LA, incurable, or m-KRAS G12C-mutated NSCLC CodeBreaK 200 phase III study - imageId : 258550. # Codebreak-200#ESMO #KRAS #Mirati . Author: Shreeya Nanda. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Methods Please enable JavaScript on your browser, so that you can use all features of this website. The ORR with sotorasib was 28.1% compared with 13.2% with docetaxel (p < 0.001). Published: 1st Sep 2022 Share. Any degree of tumor shrinkage was seen in 80.4% of patients treated with sotorasib compared with 62.8% in those treated with docetaxel. H. Borghaei: Research grant/Funding (institution): Millennium; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck; Advisory/Consultancy, Research grant/Funding (institution): Celgene; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Lilly; Advisory/Consultancy, Travel/Accommodation/Expenses: Genentech; Advisory/Consultancy: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: EMD-Serono; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Novartis; Advisory/Consultancy: Genmab; Advisory/Consultancy: Regeneron; Advisory/Consultancy: BioNTech; Advisory/Consultancy: Cantargia AB; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Amgen; Advisory/Consultancy: AbbVie; Advisory/Consultancy: Axiom; Advisory/Consultancy: PharmaMar; Advisory/Consultancy, Leadership role, Data and Safety Monitoring Board: Takeda; Advisory/Consultancy: Huya Bio; Advisory/Consultancy: GLG; Honoraria (self), Advisory/Consultancy: Daiichi Sankyo; Leadership role, Data and Safety Monitoring Board: University of Pennsylvania; Leadership role, Data and Safety Monitoring Board: Incyte; Shareholder/Stockholder/Stock options, Officer/Board of Directors, Scientific Advisory Board: Sonnetbio; Shareholder/Stockholder/Stock options, Officer/Board of Directors, Scientific Advisory Board: Rgenix; Honoraria (self): Pfizer. In my opinion, this supports sotorasib as a new second-line standard for patients with KRAS G12Cmutated NSCLC., For more insights: Small cell lung cancer (SCLC) Market,prostate cancer Market, ovarian cancer Market, MesotheliomaMarket. M. Reck: Honoraria (self), Honoraria for lectures and consultancy : AbbVie; Honoraria (self), Honoraria for lectures and consultancy : Amgen; Honoraria (self), Honoraria for lectures and consultancy : AstraZeneca; Honoraria (self), Honoraria for lectures and consultancy : BMS; Honoraria (self), Honoraria for lectures and consultancy : Boehringer Ingelheim; Honoraria (self), Honoraria for lectures and consultancy: Lilly; Honoraria (self), Honoraria for lectures and consultancy : Merck; Honoraria (self), Honoraria for lectures and consultancy : MSD; Honoraria (self), Honoraria for lectures and consultancy : Novartis; Honoraria (self), Honoraria for lectures and consultancy : Pfizer; Honoraria (self), Honoraria for lectures and consultancy : Roche; Honoraria (self), Honoraria for lectures and consultancy : Samsung. Johnson ML et al. E. Felip: Advisory/Consultancy, Speaker Bureau/Expert testimony: AbbVie; Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Blueprint; Advisory/Consultancy, Speaker Bureau/Expert testimony: Boehringer Ingelheim; Advisory/Consultancy, Speaker Bureau/Expert testimony: Bristol-Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony: Celgene; Advisory/Consultancy, Speaker Bureau/Expert testimony: GSK; Advisory/Consultancy, Speaker Bureau/Expert testimony: Eli Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony: Guardant Health; Advisory/Consultancy, Speaker Bureau/Expert testimony: Janssen; Advisory/Consultancy, Speaker Bureau/Expert testimony: Medscape; Advisory/Consultancy, Speaker Bureau/Expert testimony: Merck KGaA; Advisory/Consultancy, Speaker Bureau/Expert testimony: Merck Sharp & Dohme; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony: priME Oncology; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Samsung; Advisory/Consultancy, Speaker Bureau/Expert testimony: Takeda; Advisory/Consultancy, Speaker Bureau/Expert testimony: Touchime; Officer/Board of Directors, board, independent member: Grifols; Research grant/Funding (institution): Fundacin Merck Salud; Research grant/Funding (institution): Grant for Oncology Innovation EMD Serono. Phase III CodeBreak200 study results presented by Amgen at ESMO 2022 Data from Phase III CodeBreak200 study showed superior PFS of Lumakras over docetaxel in previously treated non-small cell lung cancer (NSCLC) patients Double PFS rate of Lumakras in comparison with docetaxel in KRAS G12C mutated NSCLC Sep 12, 2022 | DelveInsight As per the results published at ESMO 2022, it could be easily concluded that sotorasib showed statistical significance and superiority in the confirmatory CodeBreak200 study. To sign up for ESMO newsletters,create a myESMO account hereand select the newsletters youd like to receive. ESMO Congress 2022. ESMO 2022 CodeBreaK 200 data support sotorasib for KRAS G12C-mutated NSCLC Author: Laura Cowen medwireNews: Patients with previously treated KRAS G12C-mutated advanced non-small-cell lung cancer (NSCLC) have significantly better progression-free survival (PFS) and objective response rates (ORRs) with sotorasib than with docetaxel, research shows. I/II CodeBreaK 100 22 sotorasib KRAS G12C . ESMOKRAS G12CEGFR . 304 S. Jones Blvd #2432, Las Vegas NV 89107, 428, Corporate Park, Sector-21, Dwarka, New Delhi-110077, India. A positive study! ESMO 2022 is wrapped and two studies in particular have caught our eyes: NICHE-2: neoadjuvant Nivo/Ipi in MMR-d colon cancer CODEBREAK: sotorasib vs. docetaxel - Listen to ESMO 2022 - NICHE-2 and Codebreak 200 by OncoPharm instantly on your tablet, phone or browser - no downloads needed. 2022 Clinical Care Options, LLC. . Annals of Oncology (2020) 31 (suppl_4): S754-S840. (Morningstar) Sept 12, 2022 - Zymeworks Inc., a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today presented preliminary results from the company's Phase 1 clinical trial evaluating zanidatamab zovodotin (ZW49) for the treatment of HER2-positive tumors. . SotorasibIIICodeBreaK 200[10]sotorasib . The global phase 3 CodeBreaK 200 study enrolled 345 patients with locally advanced, unresectable, or metastatic KRAS G12C-mutated NSCLC. 3 ESMO 2022 Trial Phase 3, CodeBreak 200. Harvey rat sarcoma viral oncogene (HRAS), Kirsten rat sarcoma viral oncogene homolog (KRAS), and Neuroblastoma rat sarcoma viral oncogene (NRAS), which are located on chromosomes 11, 12, and 1. At 1-year the PFS rate was 24.8% with sotorasib and 10.1% with docetaxel, and Johnson noted that the PFS benefit was consistent across subgroups. The NICHE-2 study received a standing ovation at ESMO 2022. A qualified healthcare professional should be consulted before using any therapeutic product discussed. The most common type of KRAS mutation is KRAS G12C. You are now leaving the CCO site. Table: 000LBA10 . III CodeBreaK 200sotorasibKRAS G12C . ESMO 2022. 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