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Proffered Paper - GU, non prostate 2

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

Date

21 Sep 2020

Session

Proffered Paper - GU, non prostate 2

Presenters

Yann Vano

Citation

Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325

Authors

Y. Vano1, R.T. Elaidi2, M. Bennamoun3, C.M. Chevreau4, D. Borchiellini5, D. Pannier6, D. Maillet7, M. Gross-Goupil8, C. Tournigand9, B. Laguerre10, P. Barthélémy11, F. Joly12, G. Gravis13, S. Caruso14, C. Sun15, V. Verkarre16, W. Fridman15, J. Zucman-Rossi14, C. Sautès-Fridman15, S. Oudard17

Author affiliations

  • 1 Medical Oncology, Hôpital Européen Georges Pompidou, APHP.Centre – Université de Paris, Paris, France; Centre de Recherche des Cordeliers, INSERM, Université de Paris, Sorbonne Université, Paris, France, 75015 - Paris/FR
  • 2 Medical Oncology, ARTIC - Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie; Hôpital Européen Georges Pompidou, APHP.Centre – Université de Paris, Paris, France, 75015 - Paris/FR
  • 3 Medical Oncology, Institut Mutualiste Montsouris, 75014 - Paris/FR
  • 4 Medical Oncology, Institut Universitaire du Cancer -Toulouse- Oncopole, 31300 - Toulouse/FR
  • 5 Medical Oncology, Centre Anticancer Antoine Lacassagne, 6100 - Nice/FR
  • 6 Medical Oncology, Centre Oscar Lambret, 59020 - Lille/FR
  • 7 Medical Oncology, Centre Hospitalier Lyon Sud, 69495 - Pierre Bénite/FR
  • 8 Medical Oncology, Centre Hospitalier Universitaire de Bordeau - Hôpital Saint-André, 33000 - Bordeaux/FR
  • 9 Medical Oncology, Centre hospitalier universitaire Henri-Mondor, 94010 - Créteil/FR
  • 10 Medical Oncology, Centre Eugene - Marquis, 35042 - Rennes/FR
  • 11 Medical Oncology, Hôpitaux Universitaires de Strasbourg/ Institut de Cancérologie Strasbourg Europe, Strasbourg/FR
  • 12 Medical Oncology, Centre François Baclesse, Caen/FR
  • 13 Medical Oncology, Institut Paoli Calmettes, Institut Paoli-Calmettes, Aix-Marseille Université, Marseille/FR
  • 14 Functional Genomics Of Solid Tumors, Centre de Recherche des Cordeliers, INSERM, Université de Paris, Sorbonne Université, Paris, France, 75006 - Paris/FR
  • 15 Inflammation, Complement And Cancer, Centre de Recherche des Cordeliers, INSERM, Université de Paris, Sorbonne Université, Paris, France, 75006 - Paris/FR
  • 16 Pathology, Hôpital Européen Georges Pompidou, APHP.Centre – Université de Paris, Paris, France, 75015 - Paris/FR
  • 17 Medical Oncology, Hôpital Européen Georges Pompidou, APHP.Centre – Université de Paris; Immunotherapy and anti-angiogenic therapy in oncology, Université de Paris, INSERM, PARCC, Paris, France, 75015 - Paris/FR
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Abstract LBA25

Background

Nivolumab-ipilimumab (NI) and sunitinib/pazopanib (TKI) are indicated in m-ccRCC pts with IMDC intermediate/poor and good risk groups, respectively. Based on unsupervised analysis of genes expressed in m-ccRCC, we identified 4 groups (ccrcc1-4) with immune and angiogenic high/low features which could allow to better identify responders to either N, NI or TKI. We here report final analysis results of the BIONIKK trial.

Methods

BIONIKK is an open-label, French multicenter randomized phase 2 trial evaluating N vs. NI vs. TKI in upfront m-ccRCC according to ccrcc1-4 (35-gene signature, CITsig). ccrcc1,4 and ccrcc2,3 pts were randomized to receive N vs. NI and NI vs. TKI respectively. Primary endpoint (PE): objective response rate (ORR, RECIST1.1) per treatment and group. Secondary endpoints: progression-free survival (PFS), overall survival (OS) and tolerability. 150 pts were expected in target cohort (TC). An additional cohort was included to assess inter-platform variability.

Results

From 06/2017 to 07/2019: screened=308, randomized=202 (ALL), evaluable for PE=187 with TC=154. No correlation between ccrcc1-4 and IMDC risk groups (p=0.14). ORR (TC): N=30%, NI=44%, TKI=50%, with differences according to ccrcc1-4 (table1). ORR for NI were comparable across all groups. In ccrcc1 ORR for N was half that of NI while both were comparable in ccrcc4. In ccrcc2, ORR for TKI was as high as for NI. After a median (m) FU of 16 months (mo), mPFS (TC, mo): N=4.9, NI=10.4, TKI=NR, with again observed differences according to ccrcc1-4. OS data are not mature (events:16%). No new safety signal emerged compared to published data. CITsig in frozen and FFPE samples will be presented at the meeting. Table: LBA25

ccrcc groups 1 4 2 3
N NI N NI NI TKI NI TKI
N= (ALL, 202) 43 41 18 18 37 36 5 4
N= (TC, 154) 29 33 14 17 29 26 4 2
ORR, % (TC) 21 39 50 53 48 54 25 0
CR 0 6 7 12 14 0 0 0
PR 21 33 43 41 34 54 25 0
SD 34 37 7 18 34 31 50 100
PD 45 24 43 29 18 15 25 0

Conclusions

We demonstrate for the 1st time in m-ccRCC pts that gene expression signatures may enable to enrich response rates. An extensive translational program is planned to identify new biomarkers.

Clinical trial identification

EudraCT: 2016-003099-28; NCT029609. Release date: November 10, 2016.

Editorial acknowledgement

Legal entity responsible for the study

Association pour la Recherche des Thérapeutiques Innovantes en Cancérologie.

Funding

Association pour la Recherche des Thérapeutiques Innovantes en Cancérologie - Bristol Myers Squibb.

Disclosure

Y. Vano: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Ipsen; Honoraria (institution), Advisory/Consultancy: Sanofi; Honoraria (institution), Advisory/Consultancy: Astellas; Travel/Accommodation/Expenses: Janssen. M. Bennamoun: Honoraria (institution), Advisory/Consultancy: Bristol Myers Squibb; Honoraria (institution), Advisory/Consultancy: Janssen; Honoraria (institution), Advisory/Consultancy: Sanofi; Honoraria (institution): Astellas. C.M. Chevreau: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Honoraria (self), Advisory/Consultancy: Novartis. D. Borchiellini: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy: Ipsen; Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy: MSD. D. Pannier: Travel/Accommodation/Expenses: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Advisory/Consultancy: Janssen. D. Maillet: Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen. M. Gross-Goupil: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen. C. Tournigand: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Research grant/Funding (self): Roche; Honoraria (self), Research grant/Funding (self): MSD; Honoraria (self), Travel/Accommodation/Expenses: Bayer; Honoraria (self), Research grant/Funding (self): Amgen. B. Laguerre: Honoraria (self): Bristol Myers Squibb; Honoraria (self): Ipsen; Honoraria (self): MSD; Honoraria (self): Roche; Travel/Accommodation/Expenses: Pfizer. P. Barthélémy: Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers Squibb; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: MSD; Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Travel/Accommodation/Expenses: Astellas; Advisory/Consultancy: Eusa Pharma. F. Joly: Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers Squibb; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (institution), Advisory/Consultancy: Astellas; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Honoraria (institution), Advisory/Consultancy: Bayer; Advisory/Consultancy, Travel/Accommodation/Expenses: GSK; Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy: Clovis. G. Gravis: Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers Squibb; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (institution), Travel/Accommodation/Expenses: MSD; Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (institution): Astellas; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Honoraria (institution), Advisory/Consultancy: Bayer; Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen. S. Oudard: Honoraria (self): Bristol Myers Squibb; Honoraria (self): Pfizer; Honoraria (self): Novartis; Honoraria (self): Merck; Honoraria (self): Sanofi; Honoraria (self): Astellas; Honoraria (self): Janssen. All other authors have declared no conflicts of interest.

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