Abstract 674P
Background
Based on the survival benefits and favorable safety profile demonstrated in the phase III CheckMate (CM) 025 trial, nivolumab was approved in Europe in 2016 for patients (pts) with aRCC who have received prior therapy. Data from a large real-world population can provide important insights. The objective of this analysis is to describe the clinical characteristics of aRCC pts treated with nivolumab in France and to assess its efficacy and safety.
Methods
WITNESS (NCT03455452) is a prospective, non-interventional study that enrolled 330 pts treated with nivolumab in 2nd or 3rd line setting for aRCC in 62 institutions throughout France. The minimum follow-up was 14 months (mo). The main objective of the study is to assess overall survival (OS) at 3 years. Secondary objectives include progression-free survival (PFS) and overall response rate (ORR) assessed by the investigator; safety and description of socio-demographic, clinical characteristics, and management of pts. This interim analysis also focuses on pts receiving baseline concomitant medication.
Results
Among the 325 evaluable pts, 95% had clear-cell RCC subtype and 86% were IMDC intermediate- or poor-risk. Median age was 71 years, 32% of pts were ≥75, 39% had a Karnofsky score <80%, 70% had prior nephrectomy and 78% received nivolumab as 2nd line. Median PFS was 5.2 mo (4.5; 5.9) with a 12-mo PFS rate of 30.3% (25; 35.6). The 12-mo OS rate was 67.8% (62.5; 73.1). ORR was 28.3% and the median duration of response was 14.1 mo (11.3; 20). Treatment-related serious adverse events occurred in 37 (11%) pts. 10 pts were exposed to corticosteroids (≥ 10 mg/day of prednisone equivalents) at baseline and had shorter PFS and OS. Additional results regarding pts receiving other concomitant medications of interest at baseline with nivolumab will be presented during the congress.
Conclusions
These preliminary overall efficacy and safety results from WITNESS provide reassuring real-world evidence and were comparable to those observed in the CM 025 study. Concomitant medications at baseline may impact patients’ outcome and additional evidence is of key interest.
Clinical trial identification
NCT03455452.
Editorial acknowledgement
Legal entity responsible for the study
Bristol Myers Squibb France.
Funding
Bristol Myers Squibb France.
Disclosure
A. Thiery-Vuillemin: Financial Interests, Personal, Advisory Board, outside the submitted work: Pfizer; Financial Interests, Personal, Research Grant, outside the submitted work: Pfizer; Financial Interests, Personal, Advisory Board, outside the submitted work: Roche; Financial Interests, Personal, Other, outside the submitted work: Roche; Financial Interests, Personal, Advisory Board, outside the submitted work: MSD; Financial Interests, Personal, Other, outside the submitted work: MSD; Financial Interests, Personal, Advisory Board, outside the submitted work: Janssen; Financial Interests, Personal, Other, outside the submitted work: Janssen; Financial Interests, Personal, Advisory Board, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board, outside the submitted work: AstraZeneca; Financial Interests, Personal, Other, outside the submitted work: AstraZeneca; Financial Interests, Personal, Advisory Board, outside the submitted work: Sanofi; Financial Interests, Personal, Advisory Board, outside the submitted work: Novartis; Financial Interests, Personal, Advisory Board, outside the submitted work: Ipsen; Financial Interests, Personal, Other, outside the submitted work: Ipsen; Financial Interests, Personal, Advisory Board, outside the submitted work: Astellas Pharma; Financial Interests, Personal, Other, outside the submitted work: Astellas Pharma. L. Albiges: Financial Interests, Personal, Other, outside the submitted work: Astellas; Financial Interests, Personal, Other, outside the submitted work: AstraZeneca; Financial Interests, Personal, Other, outside the submitted work: Bellerophon; Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Other, outside the submitted work: Corvus Pharmaceuticals; Financial Interests, Personal, Other, outside the submitted work: Ipsen; Financial Interests, Personal, Other, outside the submitted work: Janssen; Financial Interests, Personal, Other, outside the submitted work: Merck; Financial Interests, Personal, Other, outside the submitted work: MSD; Financial Interests, Personal, Other, outside the submitted work: Novartis; Financial Interests, Personal, Other, outside the submitted work: Pfizer; Financial Interests, Personal, Other, outside the submitted work: Springer Healthcare. B. Escudier: Financial Interests, Personal, Other, outside the submitted work: Novartis; Financial Interests, Personal, Other, outside the submitted work: Pfizer; Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Other, outside the submitted work: Ipsen; Financial Interests, Personal, Other, outside the submitted work: EUSA Pharma; Financial Interests, Personal, Other, outside the submitted work: Roche/Genentech. P. Bigot: Financial Interests, Personal, Research Grant, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Other, outside the submitted work: Pfizer; Financial Interests, Personal, Other, outside the submitted work: Novartis; Financial Interests, Personal, Other, outside the submitted work: MSD; Financial Interests, Personal, Other, outside the submitted work: Ipsen. J. Eymard: Financial Interests, Personal, Research Grant, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Other, outside the submitted work: Pfizer; Financial Interests, Personal, Other, outside the submitted work: Ipsen. F. Calcagno: Financial Interests, Personal, Research Grant, outside the submitted work: ESAI; Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Other, outside the submitted work: Ipsen; Financial Interests, Personal, Other, outside the submitted work: Novartis - AAA. F. Schlürmann: Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Other, outside the submitted work: Pfizer; Financial Interests, Personal, Other, outside the submitted work: Ipsen; Financial Interests, Personal, Other, outside the submitted work: MSD. J. Barthomeuf: Other, Personal and Institutional, Officer, BMS employee: Bristol Myers Squibb. C. Quentric: Other, Personal and Institutional, Officer, BMS employee: Bristol Myers Squibb. Y. Vano: Non-Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb; Non-Financial Interests, Personal, Other, outside the submitted work: Pfizer; Financial Interests, Personal, Other, outside the submitted work: Novartis; Financial Interests, Personal, Other, outside the submitted work: MSD; Financial Interests, Personal, Other, outside the submitted work: Janssen; Financial Interests, Personal, Other, outside the submitted work: Sanofi; Financial Interests, Personal, Other, outside the submitted work: Astellas; Financial Interests, Personal, Other, outside the submitted work: Roche; Financial Interests, Personal, Other, outside the submitted work: Merck; Financial Interests, Personal, Other, outside the submitted work: Ipsen. P. Barthelemy: Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Other, outside the submitted work: EusaPharma; Financial Interests, Personal, Other, outside the submitted work: MSD; Financial Interests, Personal, Other, outside the submitted work: Pfizer; Financial Interests, Personal, Other, outside the submitted work: Janssen Cilag; Financial Interests, Personal, Other, outside the submitted work: Astellas; Financial Interests, Personal, Other, outside the submitted work: Novartis. All other authors have declared no conflicts of interest.