Necessary cookies enable core functionality. When also considering patients with stable disease, the overall DCR was 82.5% for sotorasib compared with 60.3% with docetaxel. 15 Blood samples were prospectively collected from 511 cancer patients and 470 non-cancer controls. MINIMAL Requirements:Google Chrome 24+,Mozilla Firefox 20+,Internet Explorer 11,Opera 1518,Apple Safari 7,SeaMonkey 2.15-2.23. Stephen Liu, MD. Format: Microsoft PowerPoint (.ppt) File Size: 273 KB Released: September 22, 2022 Acknowledgements Thanks for taking the questions. The ESMO Congress 2022 presented the very latest advances in the treatment of cancer and offered an excellent educational programme, with opportunities for an exchange of ideas among delegates through an enhanced onsite and virtual experience. Necessary cookies enable core functionality. October 05, 2022. . THOUSAND OAKS, Calif., Nov. 3, 2022 /PRNewswire/ Amgen (NASDAQ:AMGN) today announced financial results for the third quarter of 2022.Key results include: Total revenues decreased 1% to $6.7 billion in comparison to the third quarter of 2021, resulting from a 1% decline in global product sales, which reflected 8% volume growth offset primarily by 5% lower net selling price and 2% negative . H. Jack West, MD. Sotorasib can improve progression-free survival (PFS), compared with docetaxel, in patients with previously treated KRASG12C -mutated non-small cell lung cancer (NSCLC), according to results from. Johnson ML et al. Play over 265 million tracks for free on SoundCloud. Cancer Trial Results. 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. . Sotorasib versus docetaxel for previously treated non-small cell lung cancer with KRAS G12C mutation: CodeBreaK 200 phase III study. CodeBreaK 200 phase III study - imageId : 258552. The ESMO Congress 2022 presented the very latest advances in the treatment of cancer and offered an excellent educational programme, with opportunities for an exchange of ideas among delegates through an enhanced onsite and virtual experience. David Planchard, MD, PhD. Receive our scientific and educational products, events, membership and educational initiatives. 12001 Sunrise Valley Drive Current filters: LBA10 - Sotorasib versus docetaxel for previously treated non-small cell lung cancer with KRAS G12C mutation: CodeBreaK 200 phase III studyPresented by Melis. The CodeBreaK 200 trial, which was the first randomized phase 3 trial of a KRAS G12C inhibitor, also showed that sotorasib "had a more favorable safety profile," than docetaxel, reported Melissa Johnson (Sarah Cannon Research Institute, Tennessee, Nashville, USA) at the ESMO Congress 2022 in Paris, France. The median time to response was 1.4 months vs. 2.8 for sotorasib and docetaxel, respectively. CodeBreak 200. Saving you time. Dr. Myriam Chalabi, from the Netherlands, presented data for response to one dose of immunotherapy for stage III colon cancer patients with MSI. TRAEs leading to discontinuation were experienced by 9.5% of patients in the sotorasib arm compared with 11.3% with docetaxel. OBR Oncology | 526 followers on LinkedIn. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences. PRESS RELEASE PR Newswire . Please enable JavaScript on your browser, so that you can use all features of this website. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. C.H. The most common any-grade TRAEs between sotorasib and docetaxel, respectively, were diarrhea (33.7% vs. 18.5%), nausea (14.2% vs. 19.9%), alanine aminotransferase (ALT) increase (10.1% vs. 0%), aspartate aminotransferase (AST) increase (10.1% vs. 0%), and fatigue (6.5% vs. 25.2%). A lesser known result: The study also . Dr Alfredo Addeo - NSCLC Both the phase 3 CodeBreaK 200 and IPSOS trials were positive, respectively showing that sotorasib improved PFS vs SoC chemotherapy after CIT, and that first-line atezolizumab improved OS vs single-agent chemotherapy in patients who are ineligible for platinum-doublet chemotherapy Dr Thomas Winder - CRC Suite 300 ESMO 2022. These findings supported the initiation of a phase 3 trial of sotorasib versus docetaxel. Reston, VA 20191, From Clinical Care Options (CCO), experts review key data in lung cancers presented at the IASLC 2022 World Conference on Lung Cancer, Video featuring pathology experts discussing molecular testing in lung and thyroid cancers, from Clinical Care Options (CCO), Free expert video featuring a comprehensive overview of EGFR-mutated NSCLC, from Clinical Care Options (CCO), Expert commentary on adjuvant osimertinib for the treatment of resectable, early-stage EGFR+ NSCLC, from Clinical Care Options (CCO). Key eligibility criteria include age of 18 years, locally-advanced and unresectable or metastatic NSCLC, KRAS p.G12C mutation confirmed by central molecular testing, progression on at least 1 prior systemic therapy, past treatment with platinum-based doublet chemotherapy and checkpoint inhibitor given either as one line of therapy or as individual lines, and performance status ECOG 0/1. Key secondary endpoints include overall survival, objective response rate as assessed per RECIST v1.1, and patient-reported outcomes as assessed by EORTC QLQ-LC13 and QLQ-C30. THOUSAND OAKS, Calif., Nov. 3, 2022 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the third quarter of 2022. Via Ginevra 4, 6900 Lugano - CH Copyright 2022 European Society for Medical Oncology All rights reserved worldwide. Here we report the primary analysis of the phase 3 CodeBreaK 200 trial comparing sotorasib vs docetaxel in KRAS G12C-mutated NSCLC. (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. vs adjuvant pembrolizumab in resected stage III-IV melanoma:SWOG S1801. 2022Lumakras4800 . For the study, patients were randomized to receive either oral sotorasib at 960 mg per day (n = 171) or intravenous (IV) docetaxel at 75 mg/m2every 3 weeks (n = 174). 10.1016/annonc/annonc283, CodeBreak 200: A phase III multicenter study of sotorasib (AMG 510), a KRAS(G12C) inhibitor, versus docetaxel in patients with previously treated advanced non-small cell lung cancer (NSCLC) harboring KRAS p.G12C mutation, Targeted Therapies and Precision Oncology, Interpreting Oncological Study Publications, Cancer Diagnosis and Treatment Evaluation, Cancer Treatment in Special Clinical Situations, Clinical Pharmacology of Anti-Cancer Agents, International Prognostic Index Tools for Lymphoma, Anti-Cancer Agents and Biological Therapy, Drug-Drug Interactions with Kinase Inhibitors, PARP inhibition and DNA Damage Response (DDR), Cancer Aetiology, Epidemiology and Prevention, Cancer in Special situations (pregnancy, young, elderly, hereditary), Multikinase Inhibitor-Related Skin Toxicity, Precision Medicine and Validated Biomarkers, ESMO Recommendations in Precision Medicine. 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. You are now leaving the CCO site. With a question mark? This Editorial aims to present the current status of regulatory approval and the supporting clinical . 04-11-2022. October 7th, 2022 CodeBreak 200 Trial Results from the phase 3 CodeBreak 200 trial support sotorasib as a new second-line standard of care in patients with KRASG12C -mutated NSCLC, according to study presenter Melissa L. Johnson, MD, of the Sarah Cannon Research Institute in Nashville, Tennessee. This was a global, open-label, randomized phase III trial evaluating the efficacy of sotorasib versus docetaxel in KRAS mutant NSCLC patients who progressed after prior platinum-based chemotherapy and a checkpoint inhibitor. Joaquim Bellmunt, MD. Triple therapy improves PFS in aRCC versus dual therapy Presented By Dr Toni Choueiri, Dana-Farber Cancer Institute, MA, USA . M. Boyer: Advisory/Consultancy, Leadership role, Research grant/Funding (institution), Advisory Board member: Merck Sharpe & Dohme; Advisory/Consultancy, Leadership role, Research grant/Funding (institution), Advisory Board member: AstraZeneca; Advisory/Consultancy, Leadership role, Research grant/Funding (institution), Advisory Board member: Roche; Advisory/Consultancy, Leadership role, Research grant/Funding (institution), Advisory Board member: Bristol-Myers Squibb; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): Eli Lilly; Research grant/Funding (institution): Janssen; Research grant/Funding (institution): Ascentage Pharma. All funding for this site is provided directly by ESMO. Amgen added that the objective response rate (ORR), a key secondary goal of the study, was significantly higher for Lumakras than chemotherapy at rates of 28.1% and 13 . Data from Phase III CodeBreak200 study showed superior PFS of Lumakras over docetaxel in previously treated non-small cell lung cancer (NSCLC) patients, Sep 12, 2022 Sotorasib is a first-in-class small molecule that specifically and irreversibly inhibits KRASG12C by locking it in its inactive GDP-bound state. 2022 ; 17:20:00 - 17:40:00 ; " Safety findings are summarized (table). 2 min read THOUSAND OAKS, Calif., Sept. 7, 2022 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will host a webcast call for the investment community in conjunction with the. The global phase 3 CodeBreaK 200 study enrolled 345 patients with locally advanced, unresectable, or metastatic KRAS G12C-mutated NSCLC. ESMO 2022. CodeBreaK 200 phase III study - imageId : 258550. Author: Shreeya Nanda. September 01, 2022 Esmo 2022 - last-minute Kras entry takes centre stage Jacob Plieth Amgen's confirmatory Codebreak-200 trial will feature as a surprising late-breaker at Esmo's presidential session. Amgen announced detailed results from the global Phase III CodeBreaK 200 trial, which showed once-daily oral Lumakras/Lumykras (sotorasib) led to significantly superior progression-free survival (PFS; primary endpoint) and a significantly higher objective response rate (ORR; a key secondary endpoint) in patients with KRAS G12C-mutated non small cell lung cancer (NSCLC), compared with . Johnson ML, de Langen AJ, Waterhouse DM, et al. ESMO Congress 2022. H. Yang: Shareholder/Stockholder/Stock options, Full/Part-time employment: Amgen. But, despite all these concerns, Amgen is moving forward with a low 240-mg dose of Lumakras before adding Keytruda in a dose-expansion phase of the early-stage study in treatment-nave NSCLC patients. Treatment-nave patients with advanced clear cell RCC showed anti-tumor promising activity. Highlights from ESMO 2022. ESMO 2022. CodeBreak 200 POSEIDON Melissa Johnson, MD, Sarah Cannon Research Institute, Nashville, TN, provides an overview of the Phase III CodeBreaK 200 trial (NCT04303780), which compared sotorasib, an irreversible KRAS G12C inhibitor, with docetaxel in patients with KRAS G12C-mutatant advanced non-small cell lung cancer (NSCLC). Esmo 2022 Double Trouble Lumakras September 12, 2022 Esmo 2022 - double trouble for Lumakras Jacob Plieth Key data omitted from Codebreak-200's late-breaking abstract reveal cases of drug-induced liver injury, and overall survival that points the wrong way. 2022 Clinical Care Options, LLC. 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 G. Goss: Advisory/Consultancy, Travel/Accommodation/Expenses, Advisory Board member: AstraZeneca; Advisory/Consultancy, Advisory Board member: Pfizer; Advisory/Consultancy, Advisory Board member: Bristol-Myers Squibb; Advisory/Consultancy, Advisory Board member: Celgene. C. Obiozor: Shareholder/Stockholder/Stock options, Full/Part-time employment: Amgen. Patients with active brain metastases or significant cardiovascular disease will be excluded. 13 September, 2022 11:30. Sotorasib versus docetaxel for previously treated non-small cell lung cancer with KRAS G12C mutation: CodeBreaK 200 phase III study. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences. 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. Could anti-PD-L1 be the best choice as front-line therapy in platinum-ineligible patients with NSCLC? AMGEN TO WEBCAST INVESTOR CALL AT ESMO 2022. Biotechnology - Amgen Amgen exceeds expectations despite lower sales. After a median 17.7months of follow-up, median PFS was 5.6months in the sotorasib group and 4.3months in the docetaxel group, giving a statistically significant hazard ratio of 0.66 in favor of sotorasib. US biotech major Amgen reported its quarterly financial results late Thursday. Based on the results from the phase 1/2 CodeBreaK 100 safety and tolerability study, on May 28, 2021, the US Food and Drug Administration (FDA) granted accelerated approval for sotorasib for adults with advanced NSCLC and KRAS G12C mutation. For more detailed information on the cookies we use, please check our Privacy Policy. All patients had received prior platinum-based chemotherapy and a checkpoint inhibitor either concurrently or sequentially. Furthermore, individuals in the sotorasib arm had a faster median time to response than those in the docetaxel arm (1.4 vs 2.8months) and a longer median duration of response (8.6 vs 6.8months). Breast Cancer Sep 13 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. She told delegates that the findings support sotorasib as an important treatment option in this setting and reinforce the importance of [next-generation sequencing] testing for KRAS G12C.. The KRAS G12C . The median PFS was 5.6 months vs. 4.5 months (Hazard Ratio: 0.66 [95% CI: 0.51, 0.86]). 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. MISSISSAUGA, ON, Feb. 1, 2021 /CNW/ - Amgen has announced results from the Phase 2 cohort of the CodeBreaK 100 clinical study evaluating investigational sotorasib (AMG 510) in 126 patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC).These results were presented during the Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC) 2020 . 1 Sotorasib was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in May 2021 for patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, based on findings from the . In early September 2022, the oncology community was able to resume one of their most awaited annual in-person events. CodeBreak 300 (NCT05198934) is evaluating sotorasib plus panitumumab versus investigator's choice of . Published: 1st Sep 2022 Share. 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 . Cancer Trial Results. 3 However, thought leaders largely consider these results disappointing, as sotorasib was expected to perform better - for instance, no OS benefit was demonstrated. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Receive information and updates on ESMOs scientific and educational resources, events, members activities. 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 Preliminary results of the CodeBreak 200 trial were presented at ESMO 2022. 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