LBA52 EMPOWER-Lung 1: Phase III first-line (1L) cemiplimab monotherapy vs platinum-doublet chemotherapy (chemo) in advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50%

Sezer, Ahmet; Kılıçkap, Saadettin; Gümüş, Mahmut; Бондаренко, И. Н.; Özgüroǧlu, Mustafa; Gogishvili, Miranda; Türk, Hacı Mehmet; Çiçin, İrfan; Bentsion, Dmitry; Gladkov, Oleg; Clingan, Philip R.; Sriuranpong, Virote; Rizvi, Naiyer A.; Li, S.; Lee, S.; Gullo, Giuseppe; Lowy, Israel; Rietschel, Petra

doi:10.1016/j.annonc.2020.08.2285

Cited by 21 publications

(35 citation statements)

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“…We then checked the titles and abstracts, and 4,715 studies were excluded because they were not in line with the inclusion criteria. After screening the full-text of the remaining 36 potentially eligible studies, we identified 14 relevant clinical trials for the final analysis (4,(6)(7)(8)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30). Of these, one trial (26) reported two treatment arms with different regimens (durvalumab plus platinumetoposide with or without tremelimumab).…”

Section: Search Resultsmentioning

confidence: 99%

“…There were 11 trials (78.6%) with patients with NSCLC (4, 6, 7, 21-25, 27, 29, 30), and three (27.3%) with those with SCLC (8,26,28). Most studies (71.4%) evaluated immunotherapy in the first-line setting (7,8,22,23,(25)(26)(27)(28)(29)(30), whereas four trials (28.6%) assessed the efficacy in the second-or later-line setting (4,6,21,24). Seven trials (50%) included the immunotherapy-chemotherapy combination vs. SOC alone (7,8,(25)(26)(27)(28)30), both of which recruited patients with advanced or metastatic disease.…”

Section: Main Characteristics Of the Identified Trialsmentioning

confidence: 99%

“…The median follow-up duration varied between 8.8 months and 29.3 months, and most trials (78.6%) had a more than 12-months median follow-up (4, 6-8, 21-23, 26-29). Seven studies (50%) evaluated OS as the primary endpoint (4,6,21,22,24,26,27), three (23,25,30) assessed OS as the secondary endpoint (the primary endpoint was PFS), and four (7,8,28,29) chose OS and PFS as dual primary endpoints. Moreover, 50% of the included studies allowed patients who presented disease progression in the control group to crossover to the immunotherapy group.…”

Section: Main Characteristics Of the Identified Trialsmentioning

confidence: 99%

“…Ten of the 14 RCTs were included in the pooled estimation because they had available PFS data according to the BM status (4,7,8,21,(23)(24)(25)(28)(29)(30). As shown in Figure 3, BM patients treated with immunotherapy experienced a significantly lower risk of progression as compared with those treated with SOC systemic therapies (HR, 0.68; 95% CI, 0.52-0.87; P = 0.003).…”

Section: The Relationship Between Bm Status and Pfs Outcomesmentioning

confidence: 99%

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Brain Metastases Status and Immunotherapy Efficacy in Advanced Lung Cancer: A Systematic Review and Meta-Analysis

Zhu

et al. 2021

Front. Immunol.

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BackgroundBrain metastases (BMs) indicate poor outcomes and are commonly excluded in immunotherapy clinical trials in advanced lung cancer; moreover, the effect of BM status on immunotherapy efficacy is inconsistent and inconclusive. Therefore, we conducted a meta-analysis to assess the influence of BM status on immunotherapy efficacy in advanced lung cancer.MethodsElectronic databases and all major conference proceedings were searched without language restrictions according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. We extracted randomized clinical trials on lung cancer immunotherapy that had available overall survival (OS) and/or progression-free survival (PFS) data based on the BM status. All analyses were performed using random effects models.ResultsFourteen randomized clinical trials with 9,089 patients were identified. Immunotherapy conferred a survival advantage to BM patients [OS-hazard ratio (HR), 0.72; 95% confidence interval (CI), 0.58–0.90; P = 0.004; and PFS-HR, 0.68; 95% CI, 0.52–0.87, P = 0.003]. Non-BM patients could also derive a survival benefit from immunotherapy (OS-HR, 0.76; 95% CI, 0.71–0.80; P <0.001; and PFS-HR, 0.68; 95% CI, 0.56–0.82, P <0.001). The pooled ratios of OS-HRs and PFS-HRs reported in BM patients versus non-BM patients were 0.96 (95% CI, 0.78–1.18; P = 0.72) and 0.97 (95% CI, 0.79–1.20; P = 0.78), respectively, indicating no statistically significant difference between them. Subsequent sensitivity analyses did not alter the results. Subgroup analyses according to tumor type, line of therapy, immunotherapy type, study design, and representation of BM patients reconfirmed these findings.ConclusionWe demonstrated that BM status did not significantly influence the immunotherapy efficacy in lung cancer, suggesting that both BM and non-BM patients could obtain comparable benefits.Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/, identifier (CRD42020207446).

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Section: Search Resultsmentioning

confidence: 99%

Section: Main Characteristics Of the Identified Trialsmentioning

confidence: 99%

Section: Main Characteristics Of the Identified Trialsmentioning

confidence: 99%

Section: The Relationship Between Bm Status and Pfs Outcomesmentioning

confidence: 99%

See 2 more Smart Citations

Brain Metastases Status and Immunotherapy Efficacy in Advanced Lung Cancer: A Systematic Review and Meta-Analysis

Zhu

et al. 2021

Front. Immunol.

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“…(Sidhu & Tam, 2019). Ongoing clinical trials have shown that cemiplimab treatment results in high ORR and durable responses for patients with metastatic and locally advanced CSCC, and also results in high ORR and confers significant survival benefits for patients with locally advanced or metastatic NSCLC compared to platinum‐doublet chemotherapy (Migden et al, 2018; Sezer, 2020).…”

Section: Indirect Targeting Of Metastasismentioning

confidence: 99%

Targeting cancer metastasis with antibody therapeutics

Hui-lin

Smith

Spangler

2021

WIREs Nanomed Nanobiotechnol

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Cancer metastasis, the spread of disease from a primary to a distal site through the circulatory or lymphatic systems, accounts for over 90% of all cancer related deaths. Despite significant progress in the field of cancer therapy in recent years, mortality rates remain dramatically higher for patients with metastatic disease versus those with local or regional disease. Although there is clearly an urgent need to develop drugs that inhibit cancer spread, the overwhelming majority of anticancer therapies that have been developed to date are designed to inhibit tumor growth but fail to address the key stages of the metastatic process: invasion, intravasation, circulation, extravasation, and colonization. There is growing interest in engineering targeted therapeutics, such as antibody drugs, that inhibit various steps in the metastatic cascade. We present an overview of antibody therapeutic approaches, both in the pipeline and in the clinic, that disrupt the essential mechanisms that underlie cancer metastasis. These therapies include classes of antibodies that indirectly target metastasis, including anti‐integrin, anticadherin, and immune checkpoint blocking antibodies, as well as monoclonal and bispecific antibodies that are specifically designed to interrupt disease dissemination. Although few antimetastatic antibodies have achieved clinical success to date, there are many promising candidates in various stages of development, and novel targets and approaches are constantly emerging. Collectively, these efforts will enrich our understanding of the molecular drivers of metastasis, and the new strategies that arise promise to have a profound impact on the future of cancer therapeutic development. This article is categorized under: Therapeutic Approaches and Drug Discovery > Nanomedicine for Oncologic Disease

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Association of Anticancer Immune Checkpoint Inhibitors With Patient-Reported Outcomes Assessed in Randomized Clinical Trials

et al. 2022

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ImportanceThe association of immune checkpoint inhibitors (ICIs) with patient quality of life has been poorly explored.ObjectiveTo evaluate patient-reported outcomes (PROs) assessed in randomized clinical trials (RCTs) of immunotherapy-based treatments.Data SourcesThis systematic review and random-effects meta-analysis used RCTs identified in PubMed, MEDLINE, Embase, and Scopus from database inception to June 1, 2021.Study SelectionA total of 2259 RCTs were identified that assessed ICIs as monotherapy or in combination with chemotherapy or combined with another ICI and/or targeted therapy vs control groups not containing immunotherapy in patients with advanced solid tumors. Studies were reviewed independently by 2 authors.Data Extraction and SynthesisThis meta-analysis followed the PRISMA guidelines and recommendations of the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium.Main Outcomes and MeasuresThe coprimary aims of the meta-analysis were (1) pooled differences between treatment groups in the mean change of PRO score from baseline to 12 and 24 weeks of follow-up and (2) pooled differences between treatment groups in the time to deterioration of PRO score. For each end point, RCTs have been analyzed according to the type of treatment administered in the experimental group: ICIs given as monotherapy, ICIs combined with chemotherapy, or ICIs in association with another ICI and/or with targeted therapies.ResultsOf the 2259 identified RCTs, 34 (18 709 patients) met the selection criteria and were analyzed. In the group of 19 RCTs testing ICIs as monotherapy, the pooled between-groups difference of mean change from baseline to 12 weeks of follow-up was 4.6 (95% CI, 2.8-6.4), and the mean change from baseline to 24 weeks of follow-up was 6.1 (95% CI, 4.2-8.1), significantly favoring ICIs. The pooled difference was 1.4 (95% CI, −0.4 to 3.2) at week 12 and 2.5 (95% CI, −0.8 to 5.9) at week 24 in the group of 8 RCTs testing ICIs combined with chemotherapy and 2.1 (95% CI, −0.8 to 5.0) at week 12 and 2.1 (95% CI, −0.4 to 4.5) at week 24 in the group of 8 RCTs testing other ICI-containing combinations. The time to deterioration was significantly longer in the immunotherapy-containing groups compared with control groups in all 3 groups of RCTs evaluated (hazard ratios of 0.80 [95% CI, 0.70-0.91] for ICIs as monotherapy, 0.89 [95% CI, 0.78-1.00] for ICIs plus chemotherapy, and 0.78 [95% CI, 0.63-0.96] for other ICI-containing combinations).Conclusions and RelevanceImmune checkpoint inhibitors as monotherapy appear to have a favorable association with patient-reported quality of life and can be combined with other classes of anticancer drugs without worsening this quality of life.

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LBA52 EMPOWER-Lung 1: Phase III first-line (1L) cemiplimab monotherapy vs platinum-doublet chemotherapy (chemo) in advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50%

Cited by 21 publications

References 0 publications

Brain Metastases Status and Immunotherapy Efficacy in Advanced Lung Cancer: A Systematic Review and Meta-Analysis

Brain Metastases Status and Immunotherapy Efficacy in Advanced Lung Cancer: A Systematic Review and Meta-Analysis

Targeting cancer metastasis with antibody therapeutics

Association of Anticancer Immune Checkpoint Inhibitors With Patient-Reported Outcomes Assessed in Randomized Clinical Trials

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