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Proffered Paper 2 – Genitourinary tumours, non-prostate

3057 - Tailored ImmunoTherapy Approach with Nivolumab in advanced Renal Cell Carcinoma (TITAN-RCC)

Date

28 Sep 2019

Session

Proffered Paper 2 – Genitourinary tumours, non-prostate

Topics

Tumour Site

Renal Cell Cancer

Presenters

Marc-Oliver Grimm

Citation

Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394

Authors

M. Grimm1, M. Schmidinger2, I. Duran Martinez3, G. Schinzari4, E. Esteban5, M. Schmitz6, U. Schumacher7, G. Baretton8, P. Barthelemy9, B. Melichar10, N. Charnley11, D. Schrijvers12, L. Albiges13

Author affiliations

  • 1 Urology Department, Universitaetsklinikum Jena, 07747 - Jena/DE
  • 2 Department Of Internal Medicine I, Vienna General Hospital (AKH) - Medizinische Universität Wien, 1090 - Vienna/AT
  • 3 Despacho 271, Hospital Universitario Marques de Valdecilla, 39008 - Santander/ES
  • 4 Policlinico Universitario A. Gemelli, Università Cattolica del Sacro Cuore, 00168 - Rome/IT
  • 5 Departamento De Oncología Médica, Hospital Universitario Central de Asturias, 33006 - Oviedo/ES
  • 6 Institut Für Immunologie, Medizinische Fakultät Carl Gustav Carus der TU Dresden, 01307 - Dresden/DE
  • 7 Center For Clinical Studies, Universitaetsklinikum Jena, 07747 - Jena/DE
  • 8 Institut Für Pathologie, Universitätsklinik Carl Gustav Carus, 01307 - Dresden/DE
  • 9 Medical Oncology Department, C.H.U. Strasbourg-Nouvel Hopital Civil, 67000 - Strasbourg/FR
  • 10 Oncology, University Hospital Olomouc, 77520 - Olomouc/CZ
  • 11 Cancer Services, Royal Preston Hospital-Lancashire Teaching Hospitals NHS Foundation Trust, PR2 9HT - Preston/GB
  • 12 Medical Oncology, Ziekenhuisnetwerk Antwerpen-Middelheim, 2020 - Antwerp/BE
  • 13 Medical Oncology, Gustave Roussy, 94805 - Villejuif/FR

Resources

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Abstract 3057

Background

Nivolumab (N) + ipilimumab (I) has been approved for the 1st line treatment of IMDC intermediate and poor risk advanced RCC. However, administration of N+I in a fixed regimen with 4 induction cycles may result in more treatment related adverse events (AEs) compared with N alone. It is hypothesized that a tailored approach starting treatment with N alone and using N+I as immunotherapeutic boost will improve efficacy outcomes as compared to N alone and reduce AEs.

Methods

This multicentric European study enrolled 258 1st and 2nd line (after TKI) pts with IMDC intermediate and poor risk, advanced clear cell RCC between Oct. 2016 and Dec. 2018. Pts started with N 240 mg Q2W induction. Pts with early significant PD (week 8) or either SD or PD at week 16 received 2-4 N+I boost cycles. Responders (PR/CR) to N monotherapy continued with maintenance with N+I boosts only for progression. The primary endpoint is confirmed investigator assessed objective response rate (ORR) per RECIST independent in 1st and 2nd line. Secondary endpoints include activity of N monotherapy, remission rate with N+I boosts, safety, overall survival and QoL.

Results

108 1st and 99 2nd line pts were analyzed for efficacy. Median age was 65 y (range 20-87). 70 % were intermediate and 27 % poor risk. Confirmed ORR with 1st line N monotherapy was 28.7 % (95 % CI 20 - 38). Best overall response (BOR) after N induction ± N+I boosts was 37 % (95 % CI 28 - 47) and 28 % (95 % CI 20 - 38) in 1st and 2nd line, respectively. 102 pts received N+I boosts for either SD (n = 35) or PD (n = 67) until week16. Of these, 12 (12 %) and 54 (53%) had a PR/CR and SD, respectively. Two (6%) pts entering boosts for SD had PD afterwards compared to 51% with early PD. Treatment-related AEs will be presented.Table:

LBA57

1st line (n = 108)2nd line (n = 99)
n (%)Nivo mono ORRN ± N+I BORNivo mono ORRN ± N+I BOR
Complete response2 (1.9)2 (1.9)04 (4.0)
Partial response29 (26.9)38 (35.2)18 (18.2)24 (24.2)
Stable disease26 (24.1)26 (24.1)23 (23.2)25 (25.3)
Progressive disease13 (12.0)38 (35.2)16 (16.2)43 (43.4)
Early PD/Boost W822 (20.4)26 (26.3)
Not evaluable*16 (14.8)4 (3.7)16 (16.2)3 (3.0)
*

Including patients with early end of study e.g. due to death or immune related AEs

Conclusions

TITAN–RCC is the first study to assess the impact of a tailored approach using N+I as an immunotherapeutic boost. In 1st line, this significantly improved ORR compared to N mono. Further follow-up is ongoing to characterize duration and depth of response.

Clinical trial identification

EudraCT: 2016-002307-26.

Editorial acknowledgement

Legal entity responsible for the study

AIO-Studien-gGmbH, Berlin, Germany.

Funding

Bristol-Myers Squibb GmbH & Co.KGaA.

Disclosure

M. Grimm: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (self): Amgen; Honoraria (self): Apogepha; Honoraria (self): Astellas; Honoraria (self): AstraZeneca; Honoraria (self): Bayer HealthCare; Honoraria (self): Hexal; Honoraria (self), Advisory / Consultancy: Intuitive Surgical; Honoraria (self): Janssen Cilag; Honoraria (self): Ipsen Pharma; Honoraria (self): Medac; Honoraria (self): MSD; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: ONO Pharma; Honoraria (self): Pfizer; Honoraria (self): Sanofi Aventis. M. Schmidinger: Honoraria (self): Astellas; Honoraria (self): BMS; Honoraria (self): EISAI; Honoraria (self): Eusa Pharma; Honoraria (self): Exelexis; Honoraria (self): Ipsen; Honoraria (self): MSD; Honoraria (self): Pfizer; Honoraria (self): Roche. I. Duran Martinez: Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Non-remunerated activity/ies: Ipsen; Honoraria (self), Research grant / Funding (self), Travel / Accommodation / Expenses: Roche Genentech; Honoraria (self), Research grant / Funding (self), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy: Pharmacyclyc; Honoraria (self), Advisory / Consultancy: Janssen; Honoraria (self), Advisory / Consultancy: MSD. G. Baretton: Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): BMS; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Roche; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): MSD; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Pfizer. P. Barthelemy: Advisory / Consultancy: Pfizer; Advisory / Consultancy: Ipsen; Advisory / Consultancy: Novartis; Advisory / Consultancy: BMS; Advisory / Consultancy: Roche; Advisory / Consultancy: MSD; Advisory / Consultancy: Janssen Cilag; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Astellas. B. Melichar: Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Merck Serono; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Janssen; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy: Astellas; Honoraria (self), Advisory / Consultancy: Servier; Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: Pfizer. L. Albiges: Honoraria (institution): Pfizer; Honoraria (institution): Novartis; Honoraria (institution): BMS; Honoraria (institution): Ipsen; Honoraria (institution): Roche; Honoraria (institution): MSD; Honoraria (institution): AstraZeneca. All other authors have declared no conflicts of interest.

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