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ePoster Display

679P - Final results on efficacy and patient reported outcomes (PRO) of a randomized phase II trial investigating nivolumab switch-maintenance after TKI induction in metastatic clear cell renal cell carcinoma (mRCC) patients (NIVOSWITCH)

Date

16 Sep 2021

Session

ePoster Display

Topics

Tumour Site

Renal Cell Cancer

Presenters

Christopher Darr

Citation

Annals of Oncology (2021) 32 (suppl_5): S678-S724. 10.1016/annonc/annonc675

Authors

C. Darr1, S. Zschäbitz2, P. Ivanyi3, M. Wirth4, P. Staib5, M. Schostak6, L. Müller7, M. Metz8, L. Bergmann9, T. Steiner10, A. Lorch11, P. Schütt12, M. Rafiyan13, E. Hellmis14, A. Hinke15, M. Mänz16, J. Meiler17, T. Kretz18, A. Flörcken19, V. Grünwald20

Author affiliations

  • 1 Urology, University Hospital Essen, 45147 - Essen/DE
  • 2 Department Of Medical Oncology, National Center for Tumor Disease (NCT), University Hospital, Heidelberg, Heidelberg/DE
  • 3 Hematology, Hemostaseology, Oncology And Stem Cell Transplant, Hannover Medical School, 30625 - Hannover/DE
  • 4 Urology, Universitaetsklinikum Carl Gustav Carus Dresden, 01307 - Dresden/DE
  • 5 Oncology, St. Antonius-Hospital, 52249 - Eschweiler/DE
  • 6 Urology, University of Magdeburg, 39120 - Magdeburg/DE
  • 7 Onkologie & Hämatologie, Onkologie UnterEms, Emden/DE
  • 8 Onkologie, Onkologische Schwerpunktpraxis, 37073 - Göttingen/DE
  • 9 Medical Clinic Ii, Oncology, Universitätsklinikum Frankfurt (Johannes-Wolfgang Goethe Institute), 60590 - Frankfurt am Main/DE
  • 10 Urology, Helios Klinikum Erfurt, 99089 - Erfurt/DE
  • 11 Klinik Für Medizinische Onkologie Und Hämatologie Department, USZ - University Hospital Zürich, 8091 - Zurich/CH
  • 12 Onkologie, Onkologische Gemeinschaftspraxis, 33332 - Gütersloh/DE
  • 13 Onkologie, Nordwest-Krankenhaus, 60488 - Frankfurt am Main/DE
  • 14 Urologie, Urologicum-Duisburg - Praxis Walsum, 47179 - Duisburg/DE
  • 15 Research Consulting, CCRC - Cancer Clinical Research Consulting, 40595 - Düsseldorf/DE
  • 16 Aio-studien-ggmbh, AIO-Studien-gGmbH, 14057 - Berlin/DE
  • 17 Onkologie, Klinik Dr. Hancken, 21680 - Stade/DE
  • 18 Uro-oncology Dept., Urologische Gemeinschaftspraxis Heinsberg, 52525 - Heinsberg/DE
  • 19 Universitätsmedizin Berlin, Corporate Member Of Freie Universität Berlin, Humboldt-universität Zu Berlin, Department Of Hematology, Oncology, And Tumor Immunology, Campus Virchow-klinikum, Berlin, Germany, Charité-Universitätsmedizin Berlin, 13353 - Berlin/DE
  • 20 Interdisciplinary Gu Oncology, West-German Cancer Center Essen, University Hospital Essen, Essen/DE

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Abstract 679P

Background

In mRCC patients (pts) combinations of tyrosine kinase inhibitors (TKI) and checkpoint inhibitors (CPI) are considered standards of care. Our study investigated whether a 1st line switch-maintenance approach (CPI after TKI) improved outcome in mRCC.

Methods

49 mRCC pts. with partial remission (PR) or stable disease (SD) after 12 weeks TKI induction therapy were 1:1 randomized to receive either TKI continuation (24 pts.) or nivolumab (NIVO; 25 pts.; 240 or 480 mg IV q2-4wk). Objective response rate (ORR) (according to RECIST 1.1), progression free survival (PFS) and adverse events (AE, according to CTCAE v4.03) were assessed from time of randomization. KM plots/log-Rank analyses were used for time to event analyses. PRO were assessed by the FACT Kidney Symptom Index (FKSI-15). Time to deterioration (TTD) was defined as time between randomization to PRO decrease ≥3 points. Data base was closed on December 2020.

Results

Median age was 65 years, 82% were male and 4% had ECOG 2. Main metastatic sites were lung (47%), lymph nodes (27%) and liver (24%). MSKCC risk was favorable in 31%, intermediate in 65% and poor in 4%. Response to TKI induction therapy was PR in 59% and SD in 41% of pts. ORR from randomization favored TKI continuation (16 vs. 48%; P=0.03). After a median follow-up of 26.3 mo (1.3-45.6), 40 PFS events and 17 deaths occurred. PFS was 3.0 vs. 11.9 mo. (HR = 2.57 [95% CI: 1.36 – 4.89]) in favor for TKI continuation. Median OS was not reached. 2-year OS was 64% for NIVO and 66% for TKI treatment (HR = 1.12 [95% CI: 0.43 – 2.89]; P=0.82). AEs for NIVO vs. TKI occurred in 96% vs. 100%, grade 3-5: 56% vs. 71% and serious AE (SAE): 48% and 50%, respectively. Median FKSI15 score at therapy initiation to end of therapy showed no significant difference, 46 and 47 for NIVO as well as for TKI with 42 and 43. Median TTD favoured NIVO (NR) vs. TKI (6.9 mo), but difference remained insignificant (P=0.16).

Conclusions

Our data does not support the use of a switch-maintenance approach in mRCC. Although a lower degree of grade ≥3 AEs for NIVO was observed, a PRO benefit was not detected. A major limitation is the small sample size and the selection of TKI-sensitive pts.

Clinical trial identification

EudraCT 2016-002170-13; NCT02959554.

Editorial acknowledgement

Legal entity responsible for the study

AIO-Studien-gGmbH, Berlin.

Funding

Bristol-Myers Squibb.

Disclosure

P. Ivanyi: Non-Financial Interests, Personal, Expert Testimony: BMS; Non-Financial Interests, Personal, Expert Testimony: Bayer; Non-Financial Interests, Personal, Expert Testimony: EISAI; Non-Financial Interests, Personal, Expert Testimony: Ipsen; Non-Financial Interests, Personal, Expert Testimony: Merck; Non-Financial Interests, Personal, Expert Testimony: MSD; Non-Financial Interests, Personal, Expert Testimony: Novartis; Non-Financial Interests, Personal, Expert Testimony: Pfizer; Non-Financial Interests, Personal, Expert Testimony: Roche; Financial Interests, Personal, Invited Speaker: AIM; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Invited Speaker: DKG Onko Web; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Invited Speaker: EUSA; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Merck; Financial Interests, Personal, Invited Speaker: MedKom; Financial Interests, Personal, Invited Speaker: MTE-Academy; Financial Interests, Personal, Invited Speaker: MedWiss; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: NewConceptOncology; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: StreamUP!; Financial Interests, Personal, Invited Speaker: Solution Academy; Financial Interests, Personal, Invited Speaker: Onkowissen-tv.de; Financial Interests, Personal, Invited Speaker: Think Wired!; Non-Financial Interests, Personal and Institutional, Principal Investigator: BMS; Non-Financial Interests, Personal and Institutional, Principal Investigator: Bayer; Non-Financial Interests, Personal and Institutional, Principal Investigator: Ipsen; Non-Financial Interests, Personal and Institutional, Principal Investigator: Eisai; Non-Financial Interests, Personal and Institutional, Principal Investigator: Lilly; Non-Financial Interests, Personal and Institutional, Principal Investigator: Merck; Non-Financial Interests, Personal and Institutional, Principal Investigator: Novartis; Non-Financial Interests, Personal and Institutional, Principal Investigator: Pfizer; Non-Financial Interests, Personal and Institutional, Principal Investigator: MSD; Non-Financial Interests, Personal and Institutional, Principal Investigator: AstraZeneca; Non-Financial Interests, Personal and Institutional, Principal Investigator: Roche; Non-Financial Interests, Personal and Institutional, Principal Investigator: Ipsen; Financial Interests, Personal, Other, travel frand: BMS; Financial Interests, Personal, Other, Travel grand: DKG; Financial Interests, Personal, Other, travel grand: Bayer; Financial Interests, Personal, Other, travel grand: EUSA; Financial Interests, Personal, Other, travel grand: Ipsen; Financial Interests, Personal, Other, travel grand: Novartis; Financial Interests, Personal, Other, travel grand: Merck; Financial Interests, Personal, Other, travel grand: Pharmamar. P. Staib: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Janssen-Cilag; Financial Interests, Personal, Invited Speaker: Celgene; Financial Interests, Personal, Invited Speaker: Abbvie; Financial Interests, Personal, Invited Speaker: Amgen. M. Metz: Financial Interests, Personal, Invited Speaker: Sanofi Genzyme; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Biotest; Financial Interests, Personal, Invited Speaker: Medac; Financial Interests, Personal, Invited Speaker: Abbvie; Financial Interests, Personal, Invited Speaker: Celgene; Financial Interests, Personal, Invited Speaker: Hexal; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Octapharm; Financial Interests, Personal, Invited Speaker: Lilly. L. Bergmann: Non-Financial Interests, Personal, Advisory Board: EUSA Pharm; Non-Financial Interests, Personal, Advisory Board: Pfizer; Non-Financial Interests, Personal, Advisory Board: Roche; Non-Financial Interests, Personal, Advisory Board: Ipsen; Non-Financial Interests, Personal, Advisory Board: BMS. T. Steiner: Non-Financial Interests, Personal, Advisory Board: BMS; Non-Financial Interests, Personal, Advisory Board: Eisai; Non-Financial Interests, Personal, Advisory Board: Ipsen; Non-Financial Interests, Personal, Advisory Board: Novartis; Non-Financial Interests, Personal, Advisory Board: Pfizer; Non-Financial Interests, Personal, Advisory Board: EUSA. A. Lorch: Non-Financial Interests, Personal, Advisory Board: Pfizer; Non-Financial Interests, Personal, Advisory Board: Bayer; Non-Financial Interests, Personal, Advisory Board: Astellas; Non-Financial Interests, Personal, Advisory Board: BMS; Non-Financial Interests, Personal, Advisory Board: Ipsen; Non-Financial Interests, Personal, Advisory Board: MSD; Non-Financial Interests, Personal, Advisory Board: Merck; Non-Financial Interests, Personal, Advisory Board: Janssen; Non-Financial Interests, Personal, Advisory Board: Sanofi. A. Hinke: Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Roche. A. Flörcken: Financial Interests, Personal, Other, travel grant: Ipsen; Financial Interests, Personal, Other, travel grant: PharmaMar. All other authors have declared no conflicts of interest.

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