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Poster Discussion – Genitourinary tumours, non-prostate

4707 - NIVOREN GETUG-AFU 26 translational study:CD8 infiltration and PD-L1 expression are associated with outcome in patients (pts) with metastatic clear cell renal cell carcinoma (mccRCC) treated with nivolumab (N).

Date

29 Sep 2019

Session

Poster Discussion – Genitourinary tumours, non-prostate

Presenters

Yann Vano

Citation

Annals of Oncology (2019) 30 (suppl_5): v356-v402. 10.1093/annonc/mdz249

Authors

Y. Vano1, N. Rioux-Leclercq2, C. Dalban3, C. Sautès-Fridman4, A. Bougoüin5, N. Chaput6, S. Chouaib7, B. Beuselinck8, C.M. Chevreau9, M. Gross-Goupil10, S. Negrier11, B. Laguerre12, D. Borchiellini13, I. Colina-Moreno5, W.H. Fridman4, S. Chabaud3, F. Tantot14, J. Barros Monteiro14, B. Escudier15, L. Albiges15

Author affiliations

  • 1 Medical Oncology, Hôpital Européen Georges Pompidou, Assistance Publique - Hôpitaux de Paris, Université de Paris, Université Paris Descartes, 75015 - Paris/FR
  • 2 Service Anatomie Et Cytologie Pathologiques, CHU, Université de Rennes, France, Rennes/FR
  • 3 Clinical Research Department - Biostatistics Unit, Centre de lutte contre le cancer - Centre Léon Bérard, Lyon/FR
  • 4 Team Inflammation, Complement And Cancer, INSERM U1138, Centre de Recherche des Cordeliers, Sorbonne Université, Université de Paris, 75006 - Paris/FR
  • 5 Inserm U1138, Team Inflammation, Complement and Cancer, Centre de Recherche des Cordeliers, Sorbonne Université, Université de Paris, 75006 - Paris/FR
  • 6 Immuno-oncology Laboratory, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 7 Inserm U1186, Immunologie Intégrative Et Oncogénétique, Institut Gustave Roussy, Univ. Paris-Sud, Université Paris-Saclay, Villejuif/FR
  • 8 General Medical Oncology, University Hospitals Leuven, 3000 - Leuven/BE
  • 9 Medical Oncology, Institut Universitaire du Cancer -Toulouse- Oncopole, 31059 - Toulouse/FR
  • 10 Medical Oncology, CHU de Bordeaux, 33000 - Bordeaux/FR
  • 11 Medical Oncology, Centre Léon Bérard, University of Lyon, 69008 - Lyon/FR
  • 12 Medical Oncology, Centre Eugene - Marquis, 35042 - Rennes/FR
  • 13 Medical Oncology, Centre Anticancer Antoine Lacassagne, 06100 - Nice/FR
  • 14 Research And Development, Unicancer, 75654 - PARIS/FR
  • 15 Medical Oncology, Gustave Roussy - Cancer Campus, 94805 - Villejuif/FR

Resources

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Abstract 4707

Background

The NIVOREN GETUG-AFU 26 study reported safety and efficacy of N in mccRCC pts in a “real world setting”. A translationnal research program was launched to characterize immune cell populations in and around the tumor by immunohistochemistry (IHC) and correlate them with outcome on N.

Methods

All pts treated with N in the GETUG AFU 26 NIVOREN trial who consented for translational program and with available archived paraffin-embedded (FFPE) tumor tissue samples were eligible. Tumor were centrally reviewed. Densities of CD3-, CD8- and CD20-cells and tertiary lymphoid structures (TLS) were estimated by IHC. PD-L1 expression was quantified as percentage of positive tumor cells (TC) and immune cells (IC).

Results

Overall 324 pts were included. Pts had similar baseline characteristics (IMDC Good, Intermediate, Poor in 18%, 60% and 22%, respectively) than overall trial population. Median PFS was 4.5 (2.9-5.2) months and median OS 25.4 (23.6-NE) months. Highest density of CD8 T cells at the invasive margin (IM) was associated with worse PFS (2.3 vs 4.6 months, HR = 3.96 (1.84-8.51), p = 0.0001) and OS (8.6 vs 25.4 months, HR = 2.43 (0.99-5.95), p = 0.0451). PD-L1 expression on TC (³1%) was associated with worse OS (22.7 vs 29.1 months, HR = 1.51 (1.06-2.15), p = 0.0232) but not PFS (3.5 vs 4.6 months, p = 0.5121). PD-L1 expression on IC (³1%) was associated with numerically shorter median OS (24.7 months vs NR, HR = 1.34 (0.95-1.88), p = 0.0955). CD8 densities, either in the T or at the IM were associated with high PD-L1 expression (>1%) by TC or by IC (all p < 0.0001). Densities of CD3, CD20 and TLS were not significantly associated with OS or PFS. More data such as response rates and combinations of markers will be presented at the meeting.

Conclusions

We report the largest translational analysis supporting that highest CD8 density at the IM is associated with worse OS and PFS while PD-L1 expression by ³1% TC or IC is associated with worse OS in pts with mccRCC receiving N.

Clinical trial identification

NCT03013335.

Editorial acknowledgement

Legal entity responsible for the study

UNICANCER.

Funding

Institut National du Cancer, Direction Générale de l’Offre de Soins, Bristol-Myers-Squibb.

Disclosure

Y. Vano: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy: Pfizer; Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy: Merck; Travel / Accommodation / Expenses: Janssen-Cilag; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (self), Advisory / Consultancy: Astellas. N. Rioux-Leclercq: Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Janssen-Cilag; Honoraria (self), Advisory / Consultancy: Ipsen. B. Beuselinck: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): BMS. M. Gross-Goupil: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Ipsen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: GSK. S. Negrier: Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy: Eusa Pharma. D. Borchiellini: Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): MSD; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Janssen-Cilag; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Astellas; Honoraria (self), Advisory / Consultancy: Sanofi. B. Escudier: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy: Eusa Pharma; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Aveo. L. Albiges: Honoraria (institution), Advisory / Consultancy: Pfizer; Honoraria (institution), Advisory / Consultancy: BMS; Honoraria (institution), Advisory / Consultancy: Ipsen; Honoraria (institution), Advisory / Consultancy: Roche; Honoraria (institution), Advisory / Consultancy: MSD; Honoraria (institution), Advisory / Consultancy: AstraZeneca; Honoraria (institution), Advisory / Consultancy: Novartis. All other authors have declared no conflicts of interest.

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