Abstract 1468P
Background
Nivolumab (nivo) is the first immune checkpoint inhibitor approved for previously treated advanced RCC, based on the efficacy demonstrated in the CheckMate 025 trial. Efficacy data of nivo in pts with advanced nccRCC are limited, especially in real-world setting, although there is a high unmet medical need. This analysis focuses on advanced nccRCC pts enrolled in two observational studies.
Methods
WITNESS (NCT03455452) and NORA (NCT02940639) are prospective, non-interventional studies in France and Germany, respectively, including pts treated with nivo for aRCC who received 1 or 2 prior systemic therapies. This analysis aims to describe baseline characteristics and to assess overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety in the subgroup of pts with nccRCC, after a minimum follow-up of 14.1 months (mo).
Results
A total of 51 pts (46 in 2nd L and 5 in 3rd L) were enrolled with various histology subtypes (Table). Median age was 67 years. Karnofsky score was ≤ 70 for 11 pts (23.4%). Metastatic sites were mainly in lungs (n = 31), followed by liver (n = 19), bones (n = 16), and brain (n = 2). Median OS (95% CI) was 8.1 mo (5.2-20.9) with a 12-mo OS rate of 48% (34-62). Median PFS was 4.0 mo (2.6-6.7) with a 12-mo PFS rate of 25% (13- 37). ORR was 21.6%, and histology specific BOR is described in the table. Grade 3-4 treatment-related adverse events (TRAE) were reported in 7 (13.7%) pts and 5 (9.8%) pts discontinued nivo due to TRAE. Table: 1468P
| BOR, n (%) | Overall N = 51 | Papillary | Chromophobe n=3 | Other n=14 | Sarcomatoid n=6 | ||
| Overall n=34 | Type I n=16 | Type II n=18 | |||||
| Complete response | 1 (2.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 0 (0.0) |
| Partial Response | 10 (19.6) | 6 (17.7) | 3 (18.7) | 3 (16.7) | 0 (0.0) | 4 (28.6) | 1 (16.7) |
| Stable disease | 16 (31.4) | 13 (38.2) | 4 (25.0) | 9 (50.0) | 0 (0.0) | 3 (21.4) | 2 (33.3) |
| Progressive disease | 16 (31.4) | 11 (32.4) | 8 (50.0) | 3 (16.7) | 0 (0.0) | 5 (35.7) | 3 (50.0) |
| No tumor assessment | 8 (15.7) | 4 (11.8) | 1 (6.3) | 3 (16.7) | 2 (66.7) | 2 (14.3) | 0 (0.0) |
Conclusions
Real-life effectiveness data of nivo in pts with nccRCC are limited and usually reported in very small subsets. This analysis shows an encouraging anti-tumor activity, aligned with previous reports. No new safety signals have been identified.
Clinical trial identification
NCT03455452, NCT02940639.
Editorial acknowledgement
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
P. Barthelemy: Financial Interests, Personal, Other, Grants or contracts from any entity: Bristol Myers Squibb, Ipsen, MSD, Pfizer, AstraZeneca, Janssen; Financial Interests, Personal, Other, Consulting fees: Bristol Myers Squibb, Ipsen, MSD, Merck, Pfizer, Janssen-Cilag, Astellas, Amgen; Financial Interests, Personal, Invited Speaker, Honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Bristol Myers Squibb, Ipsen, MSD, Merck, Pfizer, Janssen-Cilag, Astellas, Bayer, Sanofi, Seagen, Novartis; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Bristol Myers Squibb, Ipsen, MSD, Merck, Pfizer, Janssen-Cilag, Astellas, Sanofi, Seagen, Novartis. J. Bedke: Financial Interests, Personal, Advisory Board: Astellas, AstraZeneca, Bristol Myers Squibb, EISAI, EUSA Pharma, Ipsen, Janssen, Merck Serono, MSD, Pfizer, Roche; Financial Interests, Institutional, Funding, Research funding: Astellas, AstraZeneca, Bristol Myers Squibb, EISAI, Ipsen, MSD, Nektar, Novartis, Pfizer, Roche, Seagen. L. Albiges: Financial Interests, Personal, Other, Consulting fees: Astellas, AstraZeneca, Bristol Myers Squibb, Ipsen, Janssen, Merck & Co, MSD, Novartis, Pfizer, EISAI; Financial Interests, Personal, Other, Participation on a Data Safety Monitoring Board or Advisory Board: AstraZeneca, Bristol Myers Squibb, Ipsen, Merck & Co, MSD, Novartis, Pfizer, EISAI. V. Grünwald: Financial Interests, Personal, Invited Speaker, outside the submitted work: AstraZeneca, Bristol Myers Squibb, EISAI, Ipsen, Janssen-Cilag, Merck Serono, MSD, Pfizer, Roche; Financial Interests, Personal, Advisory Board, outside the submitted work: Bristol Myers Squibb, EISAI, EUSA, Merck Serono, MSD, Nanobiotik, Pfizer, Roche; Financial Interests, Personal, Stocks/Shares, outside the submitted work: AstraZeneca, Bristol Myers Squibb, MSD, Seattle Genetics; Financial Interests, Institutional, Funding, Research funding; outside the submitted work: Bristol Myers Squibb, EISAI, Ipsen, MSD. B. Escudier: Financial Interests, Personal, Other, Personal fees: Novartis, Pfizer, Bristol Myers Squibb, Ipsen, EUSA Pharma, Roche/Genentech. H. Mueller-Huesmann: Financial Interests, Personal, Other, Honoraria: Roche, Bristol Myers Squibb, Boehringer-Ingelheim, AstraZeneca, MSD, Janssen, Merck, EISAI; Financial Interests, Institutional, Funding, Research funding: Roche, Bristol Myers Squibb, Boehringer-Ingelheim, EISAI; Financial Interests, Personal, Other, Personal travel, personal accommodations and expenses: AstraZeneca, Janssen. Y. Vano: Financial Interests, Personal, Member, Scientific committee of WITNESS study: Bristol Myers Squibb; Financial Interests, Personal, Funding, investigator-initiated study: Bristol Myers Squibb, Ipsen; Financial Interests, Personal, Other, Consulting fees: Bristol Myers Squibb, Ipsen, MSD, Novartis, Pfizer, Roche; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Bristol Myers Squibb, Ipsen, MSD, Novartis, Pfizer. P. Ivanyi: Financial Interests, Personal, Other, Consulting or expert activities: Bristol Myers Squibb, Bayer, EISAI, Ipsen, Merck, MSD, Novartis, Pfizer, Roche; Financial Interests, Personal, Stocks/Shares: AIM, AstraZeneca, Bristol Myers Squibb, Bayer, DKG-Onko-web, EISAI, EUSA, Ipsen, Merck, MedKom, MTE-Academy, MedWiss, MSD, New Concept Oncology, Novartis, Pfizer, Roche; Financial Interests, Personal, Other, Travel Grands: Bristol Myers Squibb, DKG, Bayer, EUSA, Ipsen, Novartis, Merck, PharmaMar. P. Bigot: Financial Interests, Personal, Other, Fees; during the conduct of the study: Bristol Myers Squibb; Financial Interests, Personal, Other, Fees: Pfizer, Novartis, MSD, Ipsen. E. Von der heyde: Financial Interests, Personal, Other, Partner: oncology practice at Raschplatz, Hannover; Financial Interests, Personal, Other, Consulting and advisory role: AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, EUSA Pharma, Merck, MSD, Novartis, Roche; Financial Interests, Personal, Funding, Research funding: Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Novartis, Ipsen, Lilly, Sanofi. B. Narciso: Financial Interests, Personal, Other, Fees; during the conduct of the study: Bristol Myers Squibb; Financial Interests, Personal, Other, Fees: Pfizer, Novartis, MSD, Ipsen. S. Nere: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. C. Quentric: Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb; Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. F. Brellier: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. M. Herber: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. A. Thiery-Vuillemin: Financial Interests, Personal, Other, Honoraria: Pfizer, AstraZeneca, Sanofi, Janssen, Novartis, Ipsen, Roche/Genentech, Bristol Myers Squibb, MSD, Astellas Pharma; Financial Interests, Personal, Other, Consulting or advisory role: Pfizer, AstraZeneca, Sanofi, Jansen, Novartis, Ipsen, Roche, Bristol Myers Squibb, MSD, Astellas Pharma; Financial Interests, Personal, Funding, Research funding: Pfizer; Financial Interests, Personal, Other, Travel/accommodations, expenses: Roche, MSD, Janssen, Bristol Myers Squibb, AstraZeneca, Astellas Pharma, Ipsen. M. Grimm: Financial Interests, Personal, Invited Speaker: Astellas, AstraZeneca, Bristol Myers Squibb, Ipsen Pharma, Merck Serono, MSD, Pfizer, EUSA, Janssen, Oncinfo, Deutsche Gesellschaft für Urologie; Financial Interests, Personal, Advisory Board: AstraZeneca, Bayer, Bristol Myers Squibb, EUSA Pharma, Ipsen Pharma, Merck Serono, MSD, Pfizer, Roche, Eisai, Takeda, Astellas, Ingress Health, Janssen Cilag; Financial Interests, Personal and Institutional, Invited Speaker: Bristol Myes Squibb; Financial Interests, Institutional, Invited Speaker: Intuitive Surgical. All other authors have declared no conflicts of interest.