Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial

Gogishvili, Miranda; Melkadze, Tamar; Makharadze, Tamta; Giorgadze, Davit; Dvorkin, Mikhail; Penkov, Konstantin; Лактионов, К. К.; Nemsadze, Gia; Nechaeva, Marina; Rozhkova, Irina; Kalinka, Ewa; Geßner, Christian; Moreno‐Jaime, Brizio; Passalacqua, Rodolfo; Li, Siyu; McGuire, Kristina; Kaul, M; Paccaly, Anne; Quek, Ruben G.W.; Gao, Bo; Seebach, Frank; Weinreich, David M.; Yancopouloš, George D.; Lowy, Israel; Gullo, Giuseppe; Rietschel, Petra

doi:10.1038/s41591-022-01977-y

Cited by 155 publications

(98 citation statements)

References 11 publications

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“…At this regard, new clinical trials with ICIs in NSCLC allow the enrollment of patients with HIV infection. For example, phase 3 randomized clinical trials with cemiplimab alone or in combination with chemotherapy for advanced NSCLC did include patients with controlled HIV infection, but results in the HIV-positive population have not been reported yet ( 10 , 11 ).…”

Section: Discussionmentioning

confidence: 99%

Chemo-immunotherapy for metastatic non-squamous NSCLC in a patient with HIV infection: A case report

Inno

Lattuada²,

Foti³

et al. 2023

Front. Oncol.

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Activity and safety data of chemo-immunotherapy for patients with metastatic NSCLC and known HIV infection are still limited, since HIV-positive patients were generally excluded from clinical trials. Here we report the case of a metastatic NSCLC patient with HIV infection and undetectable viral load treated with first-line chemo-immunotherapy (pembrolizumab, carboplatin and pemetrexed), achieving a meaningful and durable objective response, with no treatment-related adverse events and no HIV-related complications. This report suggests that NSCLC patients with virologically controlled HIV infection can be safely treated with chemo-immunotherapy and should not be excluded from this treatment based on their viral infection only.

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Section: Discussionmentioning

confidence: 99%

Chemo-immunotherapy for metastatic non-squamous NSCLC in a patient with HIV infection: A case report

Inno

Lattuada²,

Foti³

et al. 2023

Front. Oncol.

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“…Better median PFS and OS (18.6 vs. 13.9 months) and RR (49.2% vs. 31.9%) were observe in the combination arm compared with the chemotherapy alone group [ 36 ]. An additional combination based on cemiplimab plus platinum-doublet chemotherapy has been evaluated in the phase III EMPOWER-Lung 3 study, as first-line treatment for advanced NSCLC, irrespective of PD-L1 expression or histology [ 50 ]. Cemiplimab plus chemotherapy recorded a median OS of 21.9 months compared to 13.0 months with chemotherapy alone and has been accepted for review by the FDA.…”

Section: Current Role Of Immunotherapy In Lung Cancermentioning

confidence: 99%

“…TIGIT is a protein composed of an extracellular Ig variable domain, a transmembrane domain and a short intracellular domain endowed with one immunoreceptor tyrosine-based inhibitory motif (ITIM) and one immunoglobulin tyrosine tail (ITT)-like motif [ 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , …”

Section: Newly Immune Checkpointsmentioning

confidence: 99%

“…TIGIT belongs to the family of Poliovirus Receptor (PVR)-like proteins and shares sequence homology with other members of the PVR-like family [ 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , ...…”

Section: Newly Immune Checkpointsmentioning

confidence: 99%

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Lung Cancer Immunotherapy: Beyond Common Immune Checkpoints Inhibitors

Catalano

Shabani

Venturini

et al. 2022

Cancers

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Immunotherapy is an ever-expanding field in lung cancer treatment research. Over the past two decades, there has been significant progress in identifying immunotherapy targets and creating specific therapeutic agents, leading to a major paradigm shift in lung cancer treatment. However, despite the great success achieved with programmed death protein 1/ligand 1 (PD-1/PD-L1) monoclonal antibodies and with anti-PD-1/PD-L1 plus anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4), only a minority of lung cancer patients respond to treatment, and of these many subsequently experience disease progression. In addition, immune-related adverse events sometimes can be life-threatening, especially when anti-CTLA-4 and anti-PD-1 are used in combination. All of this prompted researchers to identify novel immune checkpoints targets to overcome these limitations. Lymphocyte activation gene-3 (LAG-3), T cell immunoglobulin (Ig) and Immunoreceptor Tyrosine-Based Inhibitory Motif (ITIM) domain (TIGIT), T cell immunoglobulin and mucin-domain containing-3 (TIM-3) are promising molecules now under investigation. This review aims to outline the current role of immunotherapy in lung cancer and to examine efficacy and future applications of the new immune regulating molecules.

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“…Drugs that inhibit PD-1 or PD-L1 (PD-(L)1 blockade) have transformed the treatment landscape for patients with advanced non-small cell lung cancer (NSCLC) without targetable driver mutations. In 2022, there are several US Food and Drug Administration-approved first-line PD-(L)-1 blockade regimens alone (IO) or in combination with platinum-doublet chemotherapy (Chemotherapy-IO), all of which demonstrated clinical benefit compared to chemotherapy [1][2][3][4][5][6][7] . The increased breadth of treatment options in newly diagnosed advanced lung cancer and lack of published head-to-head trials makes regimen selection challenging.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of PD-(L)1 blockade monotherapy compared to PD-(L)1 blockade plus chemotherapy in first-line PD-L1-positive advanced lung adenocarcinomas: A cohort study

Elkrief

Alessi

Ricciuti

et al. 2022

Preprint

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Importance: Single-agent PD-(L)1 blockade (IO) alone or in combination with chemotherapy (Chemotherapy-IO) are approved first-line therapies in patients with advanced lung adenocarcinomas (LUADs) with PD-L1 expression >1%. These regimens have not been compared prospectively. Objectives: The primary objective was to compare first-line efficacies of single-agent IO to Chemotherapy-IO in patients with advanced LUADs. Secondary objectives were to explore if clinical, pathologic, and genomic features were associated with differential response to Chemotherapy-IO vs IO. Setting: Multicenter retrospective cohort study. Participants: Patients with advanced LUADs with tumor PD-L1 >1% treated with first-line Chemotherapy-IO or IO. Exposures: Chemotherapy-IO vs IO therapy. Main outcomes: Objective response rate (ORR), progression-free survival (PFS) and overall survival (OS). Results: The cohort analyzed included 874 patients who received first-line treatment for PD-L1-positive advanced LUAD without sensitizing EGFR or ALK alterations. Relative to IO, Chemotherapy-IO was associated with improved ORR (44% vs 35%, p=0.005) and PFS in patients with tumor PD-L1>1% (HR 0.75, 95% CI 0.0.61-0.92, p=0.005) or PD-L1>50% (ORR 55% vs 38%, p<0.001; PFS HR 0.74 95%CI 0.56-0.97, p=0.032). Using propensity-adjusted analyses, only never smokers in the PD-L1 >50% subgroup derived a differential survival benefit from Chemotherapy-IO vs IO (p=0.03). Among patients with very high tumor PD-L1 expression (>90%) there were no differences in outcome between treatment groups. No genomic factors conferred differential survival benefit to Chemotherapy-IO vs IO. Conclusions and Relevance: While the addition of chemotherapy to PD-(L)1 blockade increases the probability of initial response, never-smokers with tumor PD-L1 >50% comprise the only population identified that derived an apparent survival benefit with treatment intensification.

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Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial

Cited by 155 publications

References 11 publications

Chemo-immunotherapy for metastatic non-squamous NSCLC in a patient with HIV infection: A case report

Chemo-immunotherapy for metastatic non-squamous NSCLC in a patient with HIV infection: A case report

Lung Cancer Immunotherapy: Beyond Common Immune Checkpoints Inhibitors

Efficacy of PD-(L)1 blockade monotherapy compared to PD-(L)1 blockade plus chemotherapy in first-line PD-L1-positive advanced lung adenocarcinomas: A cohort study

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