P2.14-24 An Open-Label Randomized Phase II Study of Combining Osimertinib With and Without Ramucirumab in TKI-Naïve EGFR-Mutant Metastatic NSCLC

Le, Xiuning; Zhu, Viola W.; Saltos, Andreas; Nikolinakos, Petros; Mileham, Kathryn F.; Velcheti, Vamsidhar; Husain, Hatim; Nilsson, Monique B.; Tran, Ha Xuan; Roarty, Emily; Kim, E.; Ou, S.-H.I.; Sanborn, Rachel E.; Gray, J.E.; Wong, Kah Keng; Hanna, N.H.; Papadimitrakopoulou, V.; Heymach, John V.

doi:10.1016/j.jtho.2019.08.1809

Cited by 2 publications

(2 citation statements)

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“…Additional combination regimens have been presented in abstract form including combination amivantamab, a bispecific antibody against EGFR and MET, plus lazertinib, a third-generation EGFR kinase inhibitor, as well as osimertinib plus ramucirumab, a vascular endothelial growth factor receptor (VEGFR) monoclonal antibody. 32 Both of these combinations demonstrated improvement in PFS compared to osimertinib alone at the cost of increased toxicity, although peer-reviewed publications were pending at the time of this update. Thus, although combination therapies may prolong PFS, the lack of clear OS benefit and greater associated toxicity…”

Section: Literature Review Update and Clinical Interpretationmentioning

confidence: 99%

Therapy for Stage IV Non–Small Cell Lung Cancer With Driver Alterations: ASCO Living Guideline, Version 2023.3

Jaiyesimi,

Leighl,

Ismaila

et al. 2024

JCO

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Living guidelines are developed for selected topic areas with rapidly evolving evidence that drives frequent change in recommended clinical practice. Living guidelines are updated on a regular schedule by a standing expert panel that systematically reviews the health literature on a continuous basis, as described in the ASCO Guidelines Methodology Manual . ASCO Living Guidelines follow the ASCO Conflict of Interest Policy Implementation for Clinical Practice Guidelines . Living Guidelines and updates are not intended to substitute for independent professional judgment of the treating provider and do not account for individual variation among patients. See complete disclaimer in Appendix 1 and Appendix 2 for more. Updates are published regularly and can be found at https://ascopubs.org/nsclc-da-living-guideline . PURPOSE To provide evidence-based recommendations for patients with stage IV non–small cell lung cancer with driver alterations. METHODS This ASCO living guideline offers continually updated recommendations based on an ongoing systematic review of randomized clinical trials (RCTs), with the latest time frame spanning February to October 2023. An Expert Panel of medical oncology, pulmonary, community oncology, research methodology, and advocacy experts were convened. The literature search included systematic reviews, meta-analyses, and randomized controlled trials. Outcomes of interest include efficacy and safety. Expert Panel members used available evidence and informal consensus to develop evidence-based guideline recommendations. RESULTS This guideline consolidates all previous updates and reflects the body of evidence informing this guideline topic. Eight new RCTs were identified in the latest search of the literature to date. RECOMMENDATIONS Evidence-based recommendations were updated to address first, second, and subsequent treatment options for patients based on targetable driver alterations. Additional information is available at www.asco.org/living-guidelines .

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Section: Literature Review Update and Clinical Interpretationmentioning

confidence: 99%

Therapy for Stage IV Non–Small Cell Lung Cancer With Driver Alterations: ASCO Living Guideline, Version 2023.3

Jaiyesimi,

Leighl,

Ismaila

et al. 2024

JCO

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“…Compared to osimertinib there was improvement in PFS (23.7 vs. 16.6 months, HR: 0.70 (95% CI 0.58–0.85, p < 0.001), including in patients with a history of brain metastases. Lastly, the phase 2 RAMOS trial evaluated patients with metastatic EGFRm NSCLC who were treated with osimertinib plus ramucirumab 10 mg/kg via intravenous infusion every 3 weeks compared to osimertinib alone and showed an improved PFS with combination therapy (24.8 vs. 15.6 months (HR, 0.55; 95% CI, 0.32–0.93; p = 0.023) [ 63 ]. Although these approaches demonstrate improved PFS, improvement in OS remains to be seen and these regimens will need to be carefully balanced with the increased toxicity and costs associated with these combination therapies.…”

Section: Role Of Ctdna In Advanced Egfrm Nsclcmentioning

confidence: 99%

ctDNA for the Evaluation and Management of EGFR-Mutant Non-Small Cell Lung Cancer

Desai,

Vázquez,

Arce

et al. 2024

Cancers

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Circulating tumor DNA (ctDNA) offers a new paradigm in optimizing treatment strategies for epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC). Its potential spans early-stage disease, influencing adjuvant therapy, to advanced disease, where it aids in identifying genomic markers and resistance mechanisms. This review explores the evolving landscape of utilizing liquid biopsies, specifically circulating tumor DNA (ctDNA), in the management of NSCLC with EGFR mutations. While tissue-based genomic testing remains the cornerstone for clinical decision-making, liquid biopsies offer a well-validated, guideline-recommended alternative approach. Ongoing trials integrating ctDNA for EGFR-mutant NSCLC management are also discussed, shedding light on the potential of ctDNA in early-stage disease, including its applications in prognostication, risk stratification, and minimal residual disease detection post-curative intent treatment. For advanced disease, the role of ctDNA in identifying resistance mechanisms to EGFR tyrosine kinase inhibitors (TKIs) is explored, providing insights into disease progression and guiding treatment decisions. This review also addresses the challenges, including the limitations in sensitivity of current assays for disease recurrence detection, and calls for future studies to refine treatment approaches, standardize reporting, and explore alternative biofluids for enhanced sensitivity. A systematic approach is crucial to address barriers to ctDNA deployment, ensuring equitable access, and facilitating its integration into routine clinical practice.

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P2.14-24 An Open-Label Randomized Phase II Study of Combining Osimertinib With and Without Ramucirumab in TKI-Naïve EGFR-Mutant Metastatic NSCLC

Cited by 2 publications

References 0 publications

Therapy for Stage IV Non–Small Cell Lung Cancer With Driver Alterations: ASCO Living Guideline, Version 2023.3

Therapy for Stage IV Non–Small Cell Lung Cancer With Driver Alterations: ASCO Living Guideline, Version 2023.3

ctDNA for the Evaluation and Management of EGFR-Mutant Non-Small Cell Lung Cancer

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