Safety and efficacy of nivolumab in metastatic renal cell carcinoma (mRCC): Final analysis from the NIVOREN GETUG AFU 26 study.

Authors

Laurence Albiges

Laurence Albiges

Medical Oncology, Gustave Roussy, Université Paris-Saclay, Villejuif, France, Villejuif, France

Laurence Albiges , Sylvie Negrier , Cécile Dalban , Christine Chevreau , Gwenaelle Gravis , Stephane Oudard , Brigitte Laguerre , Philippe Barthelemy , Delphine Borchiellini , Marine Gross-Goupil , Lionnel Geoffrois , Frederic Rolland , Antoine Thiery-Vuillemin , Florence Joly , Sylvain Ladoire , Florence Tantot , Bernard Escudier

Organizations

Medical Oncology, Gustave Roussy, Université Paris-Saclay, Villejuif, France, Villejuif, France, Centre Léon Bérard, Lyon, France, IUCT-Oncopôle Institut Claudius Regaud, Toulouse, France, Medical Oncology, Institut Paoli-Calmettes, Marseille, France, Hopital Europeen Georges Pompidou, Paris, France, Centre Eugène Marquis, Rennes, France, Medical Oncology, Hôpitaux Universitaires de Strasbourg, Strasbourg, France, Centre Antoine Lacassagne, Nice, France, Oncology Department, Centre Hospitalier Universitaire Saint-Andre, Bordeaux, Aquitaine, France, Bordeaux, France, Department of Medical Oncology, Institut de Cancérologie de Lorraine, Vandœuvre-Lès-Nancy, France, Department of Medical Oncology, Institut de Cancérologie de l'Ouest, Nantes, France, University Hospital Jean Minjoz, Besançon, France, Centre Francois Baclesse, Caen, France, Department of Medical Oncology, Center GF Leclerc, Dijon Cedex, France, UNICANCER, Kremlin Bicetre, France, U1015 INSERM, Gustave Roussy Cancer Campus, Paris Saclay University, Villejuif, France

Research Funding

Pharmaceutical/Biotech Company

Background: NIVOREN GETUG AFU 26 study, is a French multicenter prospective study to evaluate safety and efficacy of Nivolumab (N) in a broad “real world setting” in mRCC after failure of 1 or 2 tyrosine kinase inhibitors. Methods: Between February 2016 and June 2017, 729 pts have been enrolled across 27 institutions. Primary objective of the trial was safety assessed by grade ≥ 3 treatment related adverse event (TRAE). Results: Overall, 720 patients treated with N were included in this final analysis. All pts had clear cell mRCC. Median age was 64 years old, 77.4% were male, 84.7% had prior nephrectomy. ECOG PS was >1 in 15.0%, 21.3% pts had received prior everolimus, 22.4% pts had received more than 2 previous lines, IMDC risk groups were 18.3%/56.2%/25.5% for good/intermediate and poor risk respectively. Brain Metastasis at screening was noted in 83 (12.3%) pts. With a median follow up of 20.9 months (mo), median duration of treatment was 5.2 mo (0.5; 28.1) with 15% of pts still on therapy. Median PFS was 3.2 IC 95% [2.9; 4.6] mo. At the time of this analysis, 316 pts have died and 12 mo OS rate was 69% IC 95% [66; 73]. Objective response rate was 20.8% (1.2% CR, 19.6%PR). Stable disease was seen in 31.6% and PD in 47.6%. Noteworthy, 46.1% of pts were treated beyond progression. Overall, 123 pts (17.1%) have presented at least one grade ≥ 3 TRAE, including asthenia (2.4%), metabolic disorders (2.1%), gastro-intestinal disorders (1 .9%), musculoskeletal (1.7%), renal disorders (1.3%), hematologic (1.3%). 6 patients have developed grade 5 toxicity (2 cardiac failure, 1 macrophage activation syndrom, 1 Cerebral hemorrhage, 1 unknown). Treatment discontinuation due to any grade TRAE occurred in 54 pts (7.5%). Interestingly, pts with grade ≥ 3 TRAE had longer PFS than pts without grade ≥ 3 TRAE (HR 0.69 [0.55-0.87]). Conclusions: We report the primary objective analysis of the largest prospective real world setting study of N in mRCC. NIVOREN study demonstrates that N safety and efficacy in a “real world” prospective study are similar to the pivotal study. Grade ≥ 3 TRAE was associated with longer PFS. Clinical trial information: NCT03013335

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2019 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Renal Cell Cancer

Track

Renal Cell Cancer

Sub Track

Renal Cell Cancer

Clinical Trial Registration Number

NCT03013335

Citation

J Clin Oncol 37, 2019 (suppl 7S; abstr 542)

DOI

10.1200/JCO.2019.37.7_suppl.542

Abstract #

542

Poster Bd #

D3

Abstract Disclosures