Lumakras (sotorasib) / Amgen 
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  • ||||||||||  Krazati (adagrasib) / Mirati, Lumakras (sotorasib) / Amgen
    Review, Journal, Metastases:  KRAS G12C in advanced NSCLC: Prevalence, co-mutations, and testing. (Pubmed Central) -  Sep 9, 2023   
    Where available, next-generation sequencing is recommended to facilitate simultaneous testing of potentially actionable biomarkers in a single run to conserve tissue. Results from molecular testing should inform clinical decisions in treating patients with KRAS G12C-mutated advanced NSCLC.
  • ||||||||||  Lumakras (sotorasib) / Amgen
    Journal:  Cryo-EM structure determination of small therapeutic protein targets at 3  (Pubmed Central) -  Sep 8, 2023   
    Importantly, a structure for the key G12C mutant bound to an inhibitor drug (AMG510) reveals significant conformational differences compared to prior data in the crystalline state. The findings highlight the promise of cryo-EM scaffolds for advancing the design of drug molecules against small therapeutic protein targets in cancer and other human diseases.
  • ||||||||||  Lumakras (sotorasib) / Amgen
    Review, Journal, IO biomarker:  Small molecular inhibitors for KRAS-mutant cancers. (Pubmed Central) -  Sep 7, 2023   
    Other KRAS inhibitors are on the way to block KRAS-mutant cancers. In this review, we summarize the progress and promise of small-molecule inhibitors in clinical trials, including direct inhibitors of KRAS, pan-RAS inhibitors, inhibitors of RAS effector signaling, and immune checkpoint inhibitors or combinations with RAS inhibitors, to improve the prognosis of tumors with RAS mutations.
  • ||||||||||  Lumakras (sotorasib) / Amgen
    Trial primary completion date, Monotherapy:  CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) -  Sep 7, 2023   
    P1b/2,  N=1143, Recruiting, 
    In this review, we summarize the progress and promise of small-molecule inhibitors in clinical trials, including direct inhibitors of KRAS, pan-RAS inhibitors, inhibitors of RAS effector signaling, and immune checkpoint inhibitors or combinations with RAS inhibitors, to improve the prognosis of tumors with RAS mutations. Trial primary completion date: Jan 2025 --> May 2026
  • ||||||||||  Krazati (adagrasib) / Mirati, Lumakras (sotorasib) / Amgen
    Review, Journal:  Resistance to KRAS G12C Inhibition in Non-small Cell Lung Cancer. (Pubmed Central) -  Sep 4, 2023   
    In a fraction of patients, histologic transformation can also contribute to the development of acquire resistance. We provided a comprehensive overview of the mechanisms that limit the efficacy of this G12i and reviewed potential strategies to overcome and possibly delay the development of resistance in patients receiving KRAS directed targeted therapies.
  • ||||||||||  Krazati (adagrasib) / Mirati, Lumakras (sotorasib) / Amgen
    Journal, Metastases:  KRAS mutation in metastatic colorectal cancer: a new target. (Pubmed Central) -  Aug 25, 2023   
    In addition, we identified novel crosstalks between KRAS and its effector pathways including the AKT and JAK-STAT signalling modules. No abstract available
  • ||||||||||  Lumakras (sotorasib) / Amgen
    Journal:  Molecular Tumor Board Case Series: Targeting KRAS G12C in Lung Cancer. (Pubmed Central) -  Aug 23, 2023   
    Molecular tumor boards (MTB) not only aid in identifying targetable gene mutations by carefully reviewing NGS data, they can also take lead in creating patient access to the appropriate targeted therapy. Here we describe two patients with Kirsten Rat Sarcoma (KRAS) G12C mutation positive lung adenocarcinoma for whom MTB was able to procure AMG510 or sotorasib, a covalent KRAS G12C inhibitor, by expanded access program ahead of FDA approval.
  • ||||||||||  Safety and Efficacy of Stereotactic Radiosurgery with Concurrent Targeted Systemic Therapy for Brain Metastases (Hall B2; In Person Only; Screen: 11) -  Aug 22, 2023 - Abstract #ASTRO2023ASTRO_663;    
    Although heterogeneous, patients treated with SRS/SRT and ongoing CNS-active targeted systemic therapies have on average >6 month intracranial PFS and little evidence of significant toxicity. We observed <6% G2+ radiation necrosis for this cohort, and no particular class of agent was associated with a significantly higher rate of G2+ radiation necrosis.
  • ||||||||||  Lumakras (sotorasib) / Amgen
    Trial completion date, Trial primary completion date, Monotherapy:  CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) -  Aug 14, 2023   
    P1b/2,  N=1143, Recruiting, 
    Drugs such as sotorasib (targeting KRAS G12C) and immune checkpoint inhibitors, targeting the increased mutational load and higher neo-antigen hydrophobicity/immunogenicity merit investigation in MUTYH-mutated malignancies. Trial completion date: Jan 2029 --> Jul 2027 | Trial primary completion date: Jul 2026 --> Jan 2025
  • ||||||||||  Lumakras (sotorasib) / Amgen, ladarixin (DF-2156A) / Dompe
    Enrollment change, Trial withdrawal, Metastases:  Ladarixin With Sotorasib in Advanced NSCLC - Phase II (clinicaltrials.gov) -  Aug 14, 2023   
    P2,  N=0, Withdrawn, 
    Trial completion date: Jan 2029 --> Jul 2027 | Trial primary completion date: Jul 2026 --> Jan 2025 N=28 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  Lumakras (sotorasib) / Amgen, ladarixin (DF-2156A) / Dompe
    Enrollment open, Phase classification, Metastases:  Ladarixin With Sotorasib in Advanced NSCLC (clinicaltrials.gov) -  Aug 9, 2023   
    P1/2,  N=40, Recruiting, 
    N=28 --> 0 | Not yet recruiting --> Withdrawn Not yet recruiting --> Recruiting | Phase classification: P1 --> P1/2
  • ||||||||||  Lumakras (sotorasib) / Amgen
    Clinical guideline:  Canadian Consensus Recommendations on the Management of KRAS G12C-Mutated NSCLC. (Pubmed Central) -  Aug 1, 2023   
    Sotorasib, a first-in-class specific small molecule that irreversibly inhibits KRAS G12C, has since obtained Health Canada approval...Preliminary data indicate the activity of KRAS G12C inhibitors in brain metastases; however, the evidence is insufficient to make specific recommendations. Regular liver function monitoring is recommended when patients are prescribed KRAS G12C inhibitors due to risk of hepatotoxicity.
  • ||||||||||  Lumakras (sotorasib) / Amgen
    A Rare Event of Acute Hepatic Failure Due to Sotorasib: A Case Report (Exhibit Hall) -  Jul 29, 2023 - Abstract #ACG2023ACG_4422;    
    Liver toxicity can also be treated with symptomatically with discontinuation of the offending agent, but corticosteroids can also be used [1]. Sotorasib-induced hepatotoxicity is not well known but clinicians need to be aware of the side effect and promptly discontinue the medication to avoid fulminant hepatic failure.
  • ||||||||||  Lumakras (sotorasib) / Amgen
    So Long, Sotorasib: Drug-Induced Liver Injury Due to KRAS Inhibitor (Exhibit Hall) -  Jul 29, 2023 - Abstract #ACG2023ACG_4381;    
    Figure: Figure A: CK7 stain showing bile duct proliferation. Figure B: H&E stain (high power) showing lobular inflammation with prominent lymphocytes and scattered eosinophils.
  • ||||||||||  ASN007 / Asana BioSci, Erasca, UT MD Anderson Cancer Center, ERAS-601 / Erasca
    Trial completion, Enrollment change, Trial completion date, Metastases:  HERKULES-2: A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC (clinicaltrials.gov) -  Jul 27, 2023   
    P1b,  N=24, Completed, 
    Further studies are needed to clarify the potential benefits of immunotherapy in KRAS-mutated NSCLC patients and to identify potential biomarkers that may help predict response to therapy. Active, not recruiting --> Completed | N=200 --> 24 | Trial completion date: Mar 2024 --> Apr 2023
  • ||||||||||  Lumakras (sotorasib) / Amgen
    Real-world routine KRAS testing practices in France for patients (pts) with advanced or metastatic (AM) non-small cell lung cancer (NSCLC): Data from the ESME cohort () -  Jul 27, 2023 - Abstract #ESMO2023ESMO_2894;    
    Background Sotorasib is available in France since 2019 in clinical trials and now early access program for KRAS G12C AM NSCLC pts who progressed after ?1 treatment line...KRAS positive pts (n=3668) were tested on tumor (72.1%), metastasis (26.6%) and blood (3%). We described the main differences in pts characteristics overall as no difference was observed between pts tested for KRAS before L1 and after L1 / before L2 Table: 1402P Conclusions Approximately half of AM NSCLC pts were not tested for KRAS, without evolution between 2015-2018 and 2019-2021.The emergence of KRAS G12C inhibitors should lead to an increase in AM NSCLC pts testing according to guidelines.
  • ||||||||||  Lumakras (sotorasib) / Amgen
    SHERLOCK: Phase II Trial of Upfront Sotorasib with Chemotherapy and Bevacizumab for Advanced NSCLC with KRASG12C Mutation (Exhibit Hall) -  Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_2325;    
    SHERLOCK is a phase II, single arm, open-label, multicentre, clinical trial collaboration between the Thoracic Oncology Group of Australasia and the National Health and Medical Research Council Clinical Trials Centre, University of Sydney...A total of 52 participants will be recruited to account for dropout. The SHERLOCK trial commenced recruitment in August 2022 and the study is currently ongoing.
  • ||||||||||  elesclomol (STA-4783) / Madrigal Pharma
    Targeting ATP7A by Elesclomol-Copper Derived Endoplasmic Reticulum Stress to Mediate Cuproptosis in KRAS-G12 Mutant LUAD (Exhibit Hall) -  Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_1946;    
    Elesclomol transports exogenous copper ions into LUAD cells, activates endoplasmic reticulum stress by inducing the accumulation of misfolded proteins, and upregulates the expression of E3 ligase RNF207, which induces ubiquitination and degradation of ATP7A and further increases the retention of copper ions in cells, ultimately mediating cuproptosis of KRASG12 mutant LUAD cells. In summary, targeting copper metabolism may break through the bottleneck of KRASG12 mutant LUAD treatment.
  • ||||||||||  Krazati (adagrasib) / Mirati, ARS-1620 / Kura Oncology, J&J, Araxes Pharma, Lumakras (sotorasib) / Amgen
    Synergism of KRAS G12C Inhibitor and mTOR Inhibitor in Lung Adenocarcinoma and Squamous Cell Carcinoma (Exhibit Hall) -  Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_1213;    
    Combination of KRAS G12C inhibitor (AMG-510, MRTX849, and ARS-1620) and mTOR inhibitor (Everolimus) showed synergism in both adenocarcinoma and squamous cell carcinoma cell lines. The targetable somatic variant G12C in KARS should be explored in squamous cell carcinoma as well as in adenocarcinoma.
  • ||||||||||  Lumakras (sotorasib) / Amgen
    Enrollment change, Trial withdrawal:  Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA NSCLC (clinicaltrials.gov) -  Jul 17, 2023   
    P2,  N=0, Withdrawn, 
    Thus, if we consider these iridoids to be KRAS G12C inhibitors, they will be a boon to mankind. N=25 --> 0 | Recruiting --> Withdrawn
  • ||||||||||  zotatifin (eFT226) / eFFECTOR Therap
    Enrollment change, Trial completion date, Trial primary completion date:  Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies (clinicaltrials.gov) -  Jul 17, 2023   
    P1/2,  N=30, Recruiting, 
    N=25 --> 0 | Recruiting --> Withdrawn N=228 --> 30 | Trial completion date: Sep 2023 --> Mar 2025 | Trial primary completion date: Jul 2023 --> Dec 2024
  • ||||||||||  Lumakras (sotorasib) / Amgen, Tarlox (tarloxotinib bromide) / Pathos
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  Tarlox and Sotorasib in Patients With KRAS G12C Mutations (clinicaltrials.gov) -  Jul 12, 2023   
    P1/2,  N=5, Active, not recruiting, 
    N=228 --> 30 | Trial completion date: Sep 2023 --> Mar 2025 | Trial primary completion date: Jul 2023 --> Dec 2024 Recruiting --> Active, not recruiting | N=30 --> 5 | Trial completion date: Dec 2024 --> Dec 2023 | Trial primary completion date: Dec 2023 --> Jul 2023