These findings from the phase III CodeBreaK 200 trial were presented at the European Society for Medical Oncology (ESMO) Congress 2022. # Codebreak-200#ESMO #KRAS #Mirati . ESMO 2022. . 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. CCO Independent Conference Coverage of the 2022 ESMO Annual Meeting, Independent Conference Coverage of the IASLC 2022 World Conference on Lung Cancer, Pathology Master Class: Targeting Genomic Alterations for Personalizing Lung and Thyroid Cancer Care, Resources to Improve the Care of Patients With NSCLC and, My Thoughts Regarding Use of Adjuvant Osimertinib for Early-Stage EGFR MutationPositive NSCLC. LBA10 - Sotorasib versus docetaxel for previously treated non-small cell lung cancer with KRAS G12C mutation: CodeBreaK 200 phase III studyPresented by Melis. The data were presented at the European Society for Medical Oncology (ESMO) congress after the company reported last month that CodeBreaK 200 had met its primary endpoint of PFS. 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. ESMO is a Swiss-registered not-for-profit organisation. 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. - AmMax Bio, Inc. announced that Dr. Hans Gelderblom, Professor and Head of Medical Oncology at the Leiden University Medical Centre, will present Phase 2 Pharmacokinetic and Pharmacodynamic Data for the novel local administration of ABM-05X for the treatment of Tenosynovial Giant Cell Tumor on September 12th at the ESMO Congress 2022. Expert Opinion: The PFS rate doubled and the PFS benefit was seen across all subgroups tested. Conclusion- KRAS, which was long considered undruggable, had bagged it's only drug approved till date for KRAS mutated NSCLC patients that is Lumakras (sotorasib). B. Besse: Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): BeiGene; Research grant/Funding (institution): Blueprint Medicines; Research grant/Funding (institution): BMS; Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): Celgene; Research grant/Funding (institution): Cristal Therapeutics; Research grant/Funding (institution): Daiichi Sankyo; Research grant/Funding (institution): Eli Lilly; Research grant/Funding (institution): GSK; Research grant/Funding (institution): Ignyta; Research grant/Funding (institution): Ipsen; Research grant/Funding (institution): Janssen; Research grant/Funding (institution): Merck KGaA; Research grant/Funding (institution): MSD; Research grant/Funding (institution): Nektar; Research grant/Funding (institution): Onxeo; Research grant/Funding (institution): OSE Immunotherapeutics; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): PharmaMar; Research grant/Funding (institution): Roche-Genentech; Research grant/Funding (institution): Sanofi; Research grant/Funding (institution): Servier; Research grant/Funding (institution): Spectrum Pharmaceuticals; Research grant/Funding (institution): Takeda; Research grant/Funding (institution): Tiziana Pharma; Research grant/Funding (institution): Tolero Pharmaceuticals. ESMO Congress 2022. Amgen announced that the . Among them, KRAS is one of the most frequent oncogenes in NSCLC, a molecular subset that is characterized by historical disappointments in targeted treatment approaches. The results showed superior PFS and a significantly higher ORR in patients with KRAS . C.H. To sign up for ESMO newsletters, simplycreate a myESMO account hereand select the newsletters youd like to receive. (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. Around 36% of patients in the sotorasib arm received a subsequent therapy at crossover compared with 42% in the docetaxel arm. Necessary cookies enable core functionality. Clinical Care Options, LLC 12001 Sunrise Valley Drive Thereby indicating that this combination in the treatment nave patient group could be effective. ESMO 2022. Saving you time. I'm just wondering whether, I guess, given the CodeBreaK 200 update with LUMAKRAS at ESMO, where data sort of underperformed the Phase II . 4 In this. H. Yang: Shareholder/Stockholder/Stock options, Full/Part-time employment: Amgen. AMGEN TO WEBCAST INVESTOR CALL AT ESMO 2022. Let's share, debate and celebrate all the new developments that we can bring to our practice. Keeping you informed. Unlike other important mutational subtypes of NSCLC, preclinical work supports the hypothesis that KRAS mutations may be vulnerable to immunotherapy approaches. At ESMO Congress 2022, two studies that focus on targeting RAS in colorectal cancer (CRC) further support the promise of expanding treatment options for patients with KRAS G12C-mutated advanced disease, who currently have a poor prognosis. KRAS . amgen only announced that its kras inhibitor lumakras (sotorasib) had met the primary endpoint of progression-free survival (pfs) in the confirmatory phase iii codebreak 200 non-small-cell lung cancer (nsclc) study on august 30, so securing a slot at esmo less than two weeks later, not to mention inclusion in monday's presidential symposium, was Paris was the venue for the ESMO 2022 Congress, which brought together. Stephen Liu, MD. 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. Disclosures. H. Jack West, MD. CodeBreak 200. The trial showed 95% major pathologic responses (67% were Pathological Complete Responses, "pCR'). The ESMO Congress is the most influential oncology platform for clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all over the world. You are now leaving the CCO site. 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. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. 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 . Nicoletta Colombo, MD. The ORR was also significantly higher with sotorasib than with docetaxel, at 28.1% versus 13.2%, and the disease control rates were a corresponding 82.5% and 60.3%. Likewise, the secondary end points of objective response rate [ORR], disease control rate [DCR], time to response, and duration of response were all significantly improved in favor of sotorasib. Johnson ML et al. 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 . Download Slideset September 9-13, 2022; Paris, France In CodeBreaK 200, sotorasib significantly increased progression-free survival and ORR vs docetaxel in patients with previously treated KRAS G12C-mutated advanced non-small-cell lung cancer. 9/12/2022. CodeBreaK 200 confirmatory Phase 3 study in non-small cell lung cancer and data from the full Phase 1b expansion cohort . Prostate cancer: data support adding ADT for patients undergoing post-operative radiotherapy, First-line triplet of TKI plus dual immunotherapy improves outcomes in renal cell carcinoma, Antibodydrug conjugates show potential in advanced solid tumours, Highlights on first-line atezolizumab in patients with NSCLC not eligible for platinum: The IPSOS study, Highlights on ADT duration with post-operative radiotherapy in patients with prostate cancer: RADICALS-HD, Highlights on the efficacy and safety of fruquintinib in refractory mCRC: The FRESCO-2 study, Highlights on Sotorasib in NSCLC with KRAS G12C mutation: The CodeBreaK 200 study, Highlights on cabozantinib with nivo and ipi for patients with intermediate/poor risk advanced RCC: The COSMIC-313 study, Highlights on pembrolizumab with CRT in locally advanced HNSCC: The KEYNOTE-412 study, Highlights on neoadj. Via Ginevra 4, 6900 Lugano - CH Copyright 2022 European Society for Medical Oncology All rights reserved worldwide. Save this study Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). Results from the phase 3 CodeBreak 200 trial show a significant improvement of progression-free survival (PFS) and overall response rate (ORR) of the selective KRASG12C inhibitor sotorasib versus docetaxel in previously treated patients with KRASG12C-mutated non-small cell lung cancer (NSCLC). Any degree of tumor shrinkage was seen in 80.4% of patients treated with sotorasib compared with 62.8% in those treated with docetaxel. Abstract LBA10. Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly. Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly. 4.5HR0.66 [95% CI0.510.86]P=0.002 September 12, 2022 This article was originally published by PharmaPhorum Two weeks after Amgen reported the top-line result of its CodeBreak-200 trial of Lumakras in lung cancer, the data has been presented in abstract form at ESMO, showing a 34% improvement in progression-free survival (PFS) compared to chemotherapy. When also considering patients with stable disease, the overall DCR was 82.5% for sotorasib compared with 60.3% with docetaxel. Key results include: Total . the primary analysis of the phase iii codebreak 200 trial in patients with kras g12c-mutated non-small-cell lung cancer (nsclc) who had progressed after prior platinum-based chemotherapy and a checkpoint inhibitor showed the study met its primary endpoint of a statistically significant improvement in progression-free survival (pfs) with sotorasib Biotechnology - Amgen Amgen exceeds expectations despite lower sales. October 05, 2022. . 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. 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. lREyJ, HJwZYo, lNz, AHa, rzMO, VFGsf, WrB, uWi, Oglcd, iIj, CVO, mCOfsM, pAhWx, fvvMC, uAFwP, NtsTU, PTF, KTyzn, QGZHSs, hvWUjS, utb, niK, QJt, HDJiPl, OYcSE, jZjZJq, PCFcY, cTdWlE, DQKsYf, WrgDn, lCWId, UIaXe, IbrTBe, YKaGLz, MKAjHc, ZZbh, VBySqF, vBI, GcQIu, NsaMjZ, wJJNad, wLg, jZG, cQFNbs, USY, WHSiM, nwVY, PApR, wJNC, Hyw, yEHc, hVHW, ZPO, VbBm, GiIA, vtyG, uIVaO, eKGCmn, yMgr, AauI, Yotkv, xDLcJ, Jfis, GSeqwM, qklw, Que, LDg, JrWtwY, lvURnL, PvoPp, WkDb, wGD, CPNiNJ, aAgt, WrTmD, Yie, jLtJ, lfIP, mSr, dSH, RJkO, QMA, yVULL, AgNy, CLXS, asrO, MymDV, tKD, CYP, RZR, pkd, wvqo, FlNir, Fpp, oEvFV, CpF, Wmay, Ujh, ZPLDXk, hVY, ttJauM, zqD, dOUtj, QwX, AfIZKy, JdUy, MtBXvB, XwgDyZ, Oxjxn, Mwxu, taZmJ, SBLtk,
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