First-line nivolumab plus ipilimumab with two cycles of chemotherapy versus chemotherapy alone (four cycles) in metastatic non-small cell lung cancer: CheckMate 9LA 2-year patient-reported outcomes

Reck, Martin; Ciuleanu, Tudor-Eliade; Cobo, Manuel; Schenker, Michael; Żurawski, Bogdan; Menezes, J.; Richardet, Eduardo; Bennouna, Jaafar; Felip, Enriqueta; Juan, Óscar; Alexandru, Aurelia; Cheng, Ying; Paz‐Ares, Luis; Lü, Shun; John, Thomas; Sun, Xiaowu; Moisei, A.; Taylor, Fiona; Lawrance, R.; Zhang, Xiaoqing; Sylvester, Judi; Yuan, Yong; Blum, Steven I.; Penrod, John R.; Carbone, David P.

doi:10.1016/j.ejca.2023.01.015

Cited by 10 publications

(6 citation statements)

References 35 publications

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“…Ten additional RCTs were identified in the latest literature search that spanned from February 6 to October 30, 2023. [12][13][14][15][16][17][18][19][20][21] Most of these studies were either confirmatory studies or long-term follow-up data. Results from these studies did not necessitate a change to the recommendations; however, the quality of the evidence rating in some recommendations was modified to reflect the accumulated evidence.…”

Section: Characteristics Of Studies Identified In the Updated Literat...mentioning

confidence: 99%

Therapy for Stage IV Non–Small Cell Lung Cancer Without 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-non-da-living-guideline . PURPOSE To provide evidence-based recommendations for patients with stage IV non–small cell lung cancer (NSCLC) without 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. Ten 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 without driver alterations. Additional information is available at www.asco.org/living-guidelines .

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Section: Characteristics Of Studies Identified In the Updated Literat...mentioning

confidence: 99%

Therapy for Stage IV Non–Small Cell Lung Cancer Without Driver Alterations: ASCO Living Guideline, Version 2023.3

Jaiyesimi,

Leighl,

Ismaila

et al. 2024

JCO

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“…Combined immunotherapies involving CTLA-4 and PD-1 have shown promise in non-small cell lung cancer 4,5 and melanoma 6,7 but the use of immunoglobulins carries the risk of side effects and adverse events triggered by the immune system 8-10 . Applying methods that eliminate immunoglobulin triggered adverse events, while targeting CTLA-4 and PD-1 receptor expression, would be an enhancement to a proven therapeutic target.…”

Section: )mentioning

confidence: 99%

Magnetic Field Emulations of Small Inhibitor RNA: Effects on Implanted GL261 Tumors in C57BL/6 Immune Competent Mice

Figueroa,

Vogeli,

Butters

2023

Preprint

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Background: EMulate Therapeutics has developed a system for emulating the effects of small solvated molecules via their magnetic field recordings. Recordings of magnetic field emissions of select small inhibitor RNAs (siRNAs; murine targeting CTLA-4 and murine targeting PD-1) were tested on C57Bl/6 mice implanted subcutaneously with the GL261 murine tumor cell line. Methods: A signal composed of the concatenated recordings of siRNA molecules targeting the murine CTLA-4 and PD-1 receptors (labeled A2) was used in immune competent C57Bl/6 mice. The mice were flank implanted with the murine glioblastoma cell line GL261. Mice were exposed to the signal continuously (24 hours a day) until tumor volumes reached the designated volume limit. Tumors were excised and analyzed via PAGE/Western blot for the expression of CTLA-4, PD-1, Ki67, Caspase 3, CD4 and CD8. Terminal blood draws were used for CBCs. Results: We report the down regulation of the checkpoint inhibitors CTLA-4 in the exposed mice. Significant tumor volume reduction was observed in mice exposed to the siRNA signal compared to control mice; no adverse events were recorded. Cell blood counts (CBC) and protein expression patterns were observed to correlate with the expected function of protein expression inhibition of the targets. Conclusions: The effect of the magnetic field emission targeting CTLA-4 and PD-1 demonstrates the ability to emulate the effects of siRNA and support previously published work using this technology.

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“…Broadly, this study demonstrated a significant benefit in PFS and OS as well as durable responses in patients with both PD-L1 > 1% and PD-L1 < 1% NSCLCs, and is approved as a 'chemotherapy-free' option in the first-line treatment for patients with advanced PD-L1 > 1% NSCLC [27]. In addition, a novel regimen from the Checkmate 9LA trial incorporating two doses of platinum-doublet chemotherapy in addition to ipilimumab and nivolumab also resulted in both PFS and OS benefits for this combination compared with chemotherapy alone, and is also an approved treatment option for first-line advanced NSCLC in all-comers for PD-L1 status [57]. This regimen is thought to potentially provide the 'neoantigen release' of cytotoxic chemotherapy alongside the long-term durable outcomes seen with ipilimumab and nivolumab.…”

Section: Immunotherapy For Advanced Stage Nsclcmentioning

confidence: 99%

Immunotherapy through the Lens of Non-Small Cell Lung Cancer

Stanley

Flanagan

Reilly

et al. 2023

Cancers

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Immunotherapy has revolutionised anti-cancer treatment in solid organ malignancies. Specifically, the discovery of CTLA-4 followed by PD-1 in the early 2000s led to the practice-changing clinical development of immune checkpoint inhibitors (ICI). Patients with lung cancer, including both small cell (SCLC) and non-small cell lung cancer (NSCLC), benefit from the most commonly used form of immunotherapy in immune checkpoint inhibitors (ICI), resulting in increased survival and quality of life. In NSCLC, the benefit of ICIs has now extended from advanced NSCLC to earlier stages of disease, resulting in durable benefits and the even the emergence of the word ‘cure’ in long term responders. However, not all patients respond to immunotherapy, and few patients achieve long-term survival. Patients may also develop immune-related toxicity, a small percentage of which is associated with significant mortality and morbidity. This review article highlights the various types of immunotherapeutic strategies, their modes of action, and the practice-changing clinical trials that have led to the widespread use of immunotherapy, with a focus on ICIs in NSCLC and the current challenges associated with advancing the field of immunotherapy.

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First-line nivolumab plus ipilimumab with two cycles of chemotherapy versus chemotherapy alone (four cycles) in metastatic non-small cell lung cancer: CheckMate 9LA 2-year patient-reported outcomes

Cited by 10 publications

References 35 publications

Therapy for Stage IV Non–Small Cell Lung Cancer Without Driver Alterations: ASCO Living Guideline, Version 2023.3

Therapy for Stage IV Non–Small Cell Lung Cancer Without Driver Alterations: ASCO Living Guideline, Version 2023.3

Magnetic Field Emulations of Small Inhibitor RNA: Effects on Implanted GL261 Tumors in C57BL/6 Immune Competent Mice

Immunotherapy through the Lens of Non-Small Cell Lung Cancer

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