| As the number of hematology/oncology related FDA approvals, clinical trials, pipeline products, and genetic markers grows quickly, so does the need for up-to-date clinical information targeted for oncology professionals. Phil Taylor September 12, 2022 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. Stephen Liu, MD. Sotorasib versus docetaxel for previously treated non-small cell lung cancer with KRAS G12C mutation: CodeBreaK 200 phase III study. When also considering patients with stable disease, the overall DCR was 82.5% for sotorasib compared with 60.3% with docetaxel. Unlike other important mutational subtypes of NSCLC, preclinical work supports the hypothesis that KRAS mutations may be vulnerable to immunotherapy approaches. All rights reserved. Approximately 650 pts will be enrolled in the study globally. Receive information and updates on ESMOs scientific and educational resources, events, members activities. de la Porte de Versailles75015 ParisFrance. Presented by Melissa Johnson. 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 . Current filters: 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 ESMO 2022. THOUSAND OAKS, Calif., Nov. 3, 2022 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the third quarter of 2022. Ann Oncol. Table: 000LBA10 . 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. 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. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences. Robert Motzer, MD. The most common type of KRAS mutation is KRAS G12C. . Dr West begins by discussing CodeBreak 200, . 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. 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. The median percent change in tumor size for responders was 58.8% with sotorasib vs. 48.5% with docetaxel. 13 September, 2022 11:30. ESMO 2022 Trial Phase 3, CodeBreak 200. Saving you time. vs adjuvant pembrolizumab in resected stage III-IV melanoma:SWOG S1801. Overall survival (OS) did not differ significantly between the two treatment arms, at medians of 10.6 and 11.3months with sotorasib and docetaxel, respectively. For the trial, 345individuals with KRAS G12C-mutated NSCLC that had progressed after platinum-based chemotherapy and a checkpoint inhibitor were randomly assigned to receive oral sotorasib 960mg/day (n=171) or intravenous docetaxel 75mg/m2 every 3weeks (n=174). J. 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These findings supported the initiation of a phase 3 trial of sotorasib versus docetaxel. 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. 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 October 05, 2022. . The most common grade 3 or greater TRAEs with sotorasib were diarrhea (11.8%), ALT increase (7.7%), and AST increase (5.3%). 14 September, 2022 10:45. Sotorasib has previously been shown to provide antitumor activity and a manageable safety profile, for which it received FDA accelerated approval in this setting. 15 Blood samples were prospectively collected from 511 cancer patients and 470 non-cancer controls. ; Honoraria (self), Research grant/Funding (institution): Janssen Pharmaceutical K.K. The study was originally designed to enroll 650. ESMO 2022; ASCO 2022; ASH; EULAR 2022; AAIC 2022; EASD 2022; ERS 2022; Forthcoming Events; Top Conferences Stories. ESMO is a Swiss-registered not-for-profit organisation. 92022ESMOLumakras3CodeBreak 200 . 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. 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%. Hi, good evening. 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. Cancer Trial Results. 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. Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly. For more detailed information on the cookies we use, please check our Privacy Policy. Slides and webcasts are available to registered delegates. This site uses cookies. This is a prospective multicentre case-control study to assess the performance of a multi-omics approach including ctDNA methylation, mutations, and protein biomarkers in the early detection of nine cancer, including CRC, lung, and ovary tumours. H. 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Nicoletta Colombo, MD. OBR Oncology | 526 followers on LinkedIn. CodeBreak 200 is a global, randomized, open label, study of sotorasib versus docetaxel in NSCLC pts with KRAS p.G12C mutation. ESMO 2022. Highlights from ESMO 2022. The Company generated $2.8 billion of free cash flow for the third quarter versus $2.2 billion in the third quarter of 2021. Abstract LBA10. US biotech major Amgen reported its quarterly financial results late Thursday. Few months back, Amgen gave a first look at Lumakras-Keytruda data in NSCLC which showed high discontinuation rates which raised questions around the viability of the combination. 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). 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. ESMO 2022 is wrapped and two studies in particular have caught our eyes: NICHE-2: neoadjuvant Nivo/Ipi in MMR . A. Spira: Advisory/Consultancy, Research grant/Funding (institution): Amgen. 9/12/2022. With a question mark? C. Obiozor: Shareholder/Stockholder/Stock options, Full/Part-time employment: Amgen. 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 Annals of Oncology (2020) 31 (suppl_4): S754-S840. S.S. 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Treatment-nave patients with advanced clear cell RCC showed anti-tumor promising activity. 2022 total revenues guidance revised to $26.0 - $26.3 billion; EPS . 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 . Necessary cookies enable core functionality. 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. ESMO is a Swiss-registered not-for-profit organisation. Suite 300 Listing a study does not mean it has been evaluated by the U.S. Federal Government. Treatment-related adverse events (TRAEs) of grade 3 or worse occurred in 33.1% of participants who received sotorasib and 40.4% of those given docetaxel, with serious TRAEs reported in a respective 10.7% and 22.5%. Highlights from ESMO 2022 Skip to main content . H. Yang: Shareholder/Stockholder/Stock options, Full/Part-time employment: Amgen. 2022Lumakras4800 . The results showed superior PFS and a significantly higher ORR in patients with KRAS . OBR is an oncology-focused digital media company that provides news and information resources to oncology professionals. and will survival data for Amgen's CodeBreaK 200 in 2L+ NSCLC threaten Mirati's accelerated approval filing for . 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. C.H. SoundCloud ESMO 2022 - NICHE-2 and Codebreak 200 by OncoPharmPod published on 2022-09-15T19:48:21Z. In addition, patients receiving sotorasib also experienced a significant reduction in the risk of progression or death, according to data from the phase 3 CodeBreak 200 trial (NCT04303780), presented at the 2022 ESMO Congress. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. 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). Putting research into context. 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. Kidney cancer: 100 seconds ENG ESMO 2022. I/II CodeBreaK 100 22 sotorasib KRAS G12C . Format: Microsoft PowerPoint (.ppt) File Size: 273 KB Released: September 22, 2022 Acknowledgements ESMO 2022. 2022 Clinical Care Options, LLC. On September 12, 2022, at the European Society for Medical Oncology (ESMO) Congress meeting, the results were reported from the phase 3 CodeBreaK 200 randomized, controlled clinical trial (NCT04303780) . Sotorasib versus docetaxel for previously treated non-small cell lung cancer with KRAS G12C mutation: CodeBreaK 200 phase III study. 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 . . Thanks for taking the questions. 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. These findings from the phase III CodeBreaK 200 trial were presented at the European Society for Medical Oncology (ESMO) Congress 2022. The median PFS was 5.6 months vs. 4.5 months (Hazard Ratio: 0.66 [95% CI: 0.51, 0.86]). Image for ESMO 2022: Sotorasib versus docetaxel for previously treated non-small cell lung cancer with KRAS G12C mutation: CodeBreaK 200 phase III study - imageId : 258552 . Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly. K. Park: Advisory/Consultancy: Amgen. The KRAS G12C . F. Griesinger: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Amgen; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Blueprint; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Boehringer Ingelheim; Advisory/Consultancy, Speaker Bureau/Expert testimony: Chugai; Advisory/Consultancy, Speaker Bureau/Expert testimony: Janssen; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Takeda; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Siemens; Advisory/Consultancy, Speaker Bureau/Expert testimony: AbbVie. 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). 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). 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. 304 S. Jones Blvd #2432, Las Vegas NV 89107, 428, Corporate Park, Sector-21, Dwarka, New Delhi-110077, India. Disclosures. Trial design CodeBreak 200 is a global, randomized, open label, study of sotorasib versus docetaxel in NSCLC pts with KRAS p.G12C mutation. Summary: Preliminary data from the CodeBreaK 200 trial shows that sotorasib provides significant PFS, ORR, and DCR benefit over docetaxel with fewer AEs. A qualified healthcare professional should be consulted before using any therapeutic product discussed. ESMO 2022 (Late-Breaking, Proffered Paper, Symposia) . 12001 Sunrise Valley Drive ; Honoraria (self), Research grant/Funding (institution): Kyowa Hakko Kirin Co., Ltd; Honoraria (self), Research grant/Funding (institution): Life Technologies; Honoraria (self), Research grant/Funding (institution): Lilly; Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self): Nippon Kayaku; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self), Research grant/Funding (institution): Ono Pharmaceutical; Honoraria (self), Advisory/Consultancy: Otsuka Pharmaceutica; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self), Research grant/Funding (institution): Taiho Pharmaceutical; Honoraria (self), Research grant/Funding (institution): Takeda; Advisory/Consultancy, Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Eisai; Research grant/Funding (institution): Ignyta; Research grant/Funding (institution): Loxo; Research grant/Funding (institution): Medical & Biological Laboratories Co., Ltd; Research grant/Funding (institution): Merck Serono; Research grant/Funding (institution): Riken Genesis; Research grant/Funding (institution): Sumitomo Dainippon; Research grant/Funding (institution): Sysmex Corporation; Research grant/Funding (institution): Xcoo.
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