LBA25 Results from the phase II biomarker driven trial with nivolumab (N) and ipilimumab or VEGFR tyrosine kinase inhibitor (TKI) in naïve metastatic kidney cancer (m-ccRCC) patients (pts): The BIONIKK trial

Vano, Yann-Alexandre; Elaidi, R.T.; Bennamoun, Mostefa; Chevreau, Christine; Borchiellini, Delphine; Pannier, Diane; Maillet, Denis; Gross‐Goupil, Marine; Tournigand, Christophe; Laguerre, Brigitte; Barthélémy, Philippe; Joly, Florence; Gravis, Gwénaëlle; Caruso, Stefano; Sun, Chao; Verkarre, Virginie; Wh, Fridman; Zucman–Rossi, Jessica; Sautès-Fridman, Catheriné; Оудард, С.

doi:10.1016/j.annonc.2020.08.2254

Cited by 30 publications

(28 citation statements)

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“…The main objective was the overall response rates by the treatment arm and molecular group. The main results were reported at the last ESMO (virtual) meeting and confirmed the hypotheses describe above: nivolumab provided a comparable ORR to nivolumab-ipilimumab in ccrcc4 but not in ccrcc1, whereas the ORR were comparable between the TKI and nivolumab-ipilimumab in ccrcc2 [ 110 ]. A huge biomarker program is ongoing, including the evaluation of the mRNA signatures described earlier in this review.…”

Section: Perspectives: the Bionikk Trial As An Example Of Integratsupporting

confidence: 64%

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Tumor Microenvironment Features as Predictive Biomarkers of Response to Immune Checkpoint Inhibitors (ICI) in Metastatic Clear Cell Renal Cell Carcinoma (mccRCC)

Simonaggio

Epaillard

Pobel

et al. 2021

Cancers

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Renal cell carcinoma (RCC) is the seventh most frequently diagnosed malignancy with an increasing incidence in developed countries. Despite a greater understanding of the cancer biology, which has led to an increase of therapeutic options, metastatic clear cell renal cell carcinoma (mccRCC) still have a poor prognosis with a median five-years survival rate lower than 10%. The standard of care for mccRCC has changed dramatically over the past decades with the emergence of new treatments: anti-VEGFR tyrosine kinase inhibitors, mTOR Inhibitors and immune checkpoint inhibitors (ICI) such as anti-Programmed cell-Death 1 (PD-1) and anti-anti-Programmed Death Ligand-1 (PD-L1) used as monotherapy or as a combination with anti CTLA-4 or anti angiogenic therapies. In the face of these rising therapeutic options, the question of the therapeutic sequences is crucial. Predictive biomarkers are urgently required to provide a personalized treatment for each patient. Disappointingly, the usual ICI biomarkers, PD-L1 expression and Tumor Mutational Burden, approved in melanoma or non-small cell lung cancer (NSCLC) have failed to distinguish good and poor mccRCC responders to ICI. The tumor microenvironment is known to be involved in ICI response. Innovative technologies can be used to explore the immune contexture of tumors and to find predictive and prognostic biomarkers. Recent comprehensive molecular characterization of RCC has led to the development of robust genomic signatures, which could be used as predictive biomarkers. This review will provide an overview of the components of the RCC tumor microenvironment and discuss their role in disease progression and resistance to ICI. We will then highlight the current and future ICI predictive biomarkers assessed in mccRCC with a major focus on immunohistochemistry markers and genomic signatures.

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Section: Perspectives: the Bionikk Trial As An Example Of Integratsupporting

confidence: 64%

“…BIONIKK (NCT02960906) was the first prospective clinical trial studying the personalization of treatments according to tumor molecular characteristics in mccRCC [ 110 , 111 ]. Molecular characteristics are assessed by the CIT classification, described in Section 4 .…”

Section: Perspectives: the Bionikk Trial As An Example Of Integratmentioning

confidence: 99%

Tumor Microenvironment Features as Predictive Biomarkers of Response to Immune Checkpoint Inhibitors (ICI) in Metastatic Clear Cell Renal Cell Carcinoma (mccRCC)

Simonaggio

Epaillard

Pobel

et al. 2021

Cancers

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“…All these heterogeneity sources can explain why some markers can be found to be significantly associated with survival in some studies and not in others. In this context, it is important to note that some markers, notably the ccrcc1-4 molecular subtyping, proved to be related to older therapies, notably antiangiogenic drugs ( 158 ), but their predictive power is being considered also for more recent immunotherapies with immune checkpoint inhibitors, as illustrated in clinical trials [BIONIKK trial, NCT02960906 ( 167 )].…”

Section: Resultsmentioning

confidence: 99%

Review of Prognostic Expression Markers for Clear Cell Renal Cell Carcinoma

et al. 2021

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Context: The number of prognostic markers for clear cell renal cell carcinoma (ccRCC) has been increasing regularly over the last 15 years, without being integrated and compared.Objective: Our goal was to perform a review of prognostic markers for ccRCC to lay the ground for their use in the clinics.Evidence Acquisition: PubMed database was searched to identify RNA and protein markers whose expression level was reported as associated with survival of ccRCC patients. Relevant studies were selected through cross-reading by two readers.Evidence Synthesis: We selected 249 studies reporting an association with prognostic of either single markers or multiple-marker models. Altogether, these studies were based on a total of 341 distinct markers and 13 multiple-marker models. Twenty percent of these markers were involved in four biological pathways altered in ccRCC: cell cycle, angiogenesis, hypoxia, and immune response. The main genes (VHL, PBRM1, BAP1, and SETD2) involved in ccRCC carcinogenesis are not the most relevant for assessing survival.Conclusion: Among single markers, the most validated markers were KI67, BIRC5, TP53, CXCR4, and CA9. Of the multiple-marker models, the most famous model, ClearCode34, has been highly validated on several independent datasets, but its clinical utility has not yet been investigated.Patient Summary: Over the years, the prognosis studies have evolved from single markers to multiple-marker models. Our review highlights the highly validated prognostic markers and multiple-marker models and discusses their clinical utility for better therapeutic care.

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“…Auch wenn die Überlebensdaten der BIONIKK Studie bezüglich des Gesamtüberlebens noch nicht reif sind, konnten die Autoren ihre Hypothese bestätigen, da Sunitinib der Checkpointinhibition in Cluster 2 nicht unterlegen war. In Cluster 4, nicht aber in Cluster 1, war Nivolumab alleine gegenüber Nivolumab + Ipililumab vergleichbar [46].…”

Section: Molekulare Grundlagen Der Klarzelligen Nierenzellkarzinomeunclassified

Biomarker: der Weg zur individualisierten Therapie bei Nierenzelltumoren

2021

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ZusammenfassungIn den letzten drei Jahrzehnten wurden Nierentumore, basierend auf histopathologischen und molekularen Merkmalen, immer umfassender differenziert. Dies hat inzwischen eine zunehmend größere Bedeutung für die klinische Praxis, da differenzierte Therapieoptionen sowohl für die organbegrenzten als auch für die metastasierten Nierenzelltumore zur Verfügung stehen. Die Kenntnis der molekularen Veränderungen ist Voraussetzung für die Entwicklung, aber auch für die differenzierte Anwendung zielgerichteter systemischer Therapieverfahren. Diese Arbeit gibt einerseits einen Überblick über die molekulare Differenzierung der Nierentumore, andererseits werden molekulare Biomarker zur Diagnose, Prognosebewertung und Therapieentscheidung vorgestellt und kritisch diskutiert.

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LBA25 Results from the phase II biomarker driven trial with nivolumab (N) and ipilimumab or VEGFR tyrosine kinase inhibitor (TKI) in naïve metastatic kidney cancer (m-ccRCC) patients (pts): The BIONIKK trial

Cited by 30 publications

References 0 publications

Tumor Microenvironment Features as Predictive Biomarkers of Response to Immune Checkpoint Inhibitors (ICI) in Metastatic Clear Cell Renal Cell Carcinoma (mccRCC)

Tumor Microenvironment Features as Predictive Biomarkers of Response to Immune Checkpoint Inhibitors (ICI) in Metastatic Clear Cell Renal Cell Carcinoma (mccRCC)

Review of Prognostic Expression Markers for Clear Cell Renal Cell Carcinoma

Biomarker: der Weg zur individualisierten Therapie bei Nierenzelltumoren

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