Abstract 2368
Background
Depth of response (DepOR; max % reduction from baseline in sum of target lesion diameters), has shown prognostic value for long-term survival in multiple malignancies. Among aRCC patients (pts) in CheckMate 214, objective response and complete response rates were higher and more durable, and overall survival (OS) was greater (intention-to-treat: HR 0.71, P = 0.0003; intermediate/poor-risk pts: HR 0.66, P < 0.0001), for nivolumab + ipilimumab (N+I) vs sunitinib (S) at 30-mo min follow-up. This exploratory analysis evaluated the relationship between DepOR and OS in CheckMate 214 to determine a potential DepOR threshold predictive of long-term OS with N+I.
Methods
Pts with previously untreated aRCC were randomized 1:1 to N+I (3 mg/kg + 1 mg/kg IV) Q3W for 4 doses, followed by N (3 mg/kg IV) Q2W, or S 50 mg/day orally for 4 wk (6-wk cycles). An exploratory analysis of OS by DepOR quartiles was conducted (Q0, no reduction; Q1, >0–≤25%; Q2, >25–≤50%; Q3, >50–≤75%; Q4, >75–≤100%).
Results
Of 550 and 546 pts randomized to N+I or S, 479 and 459, respectively, had postbaseline target lesion measurements. Overall, greater DepOR was associated with improved OS (Table). Pts on N+I with >50–≤75% (Q3) tumor reduction had similar OS as those with >75% (Q4) reduction, whereas only Q4 pts achieved comparable OS with S (203/550 [37%] N+I vs 46/546 [8%] S randomized pts). Receiver operating characteristic analysis supported a > 50% DepOR threshold for greatest OS benefit with N+I. Additional analyses of the relationship between DepOR and outcomes across arms will be presented.Table:
950P
DepOR | N+I N = 479 | S N = 459 | ||||
---|---|---|---|---|---|---|
n (%) | Median OS, mo (95% CI) | OS probability vs Q0, HR (95% CI) | n (%) | Median OS, mo (95% CI) | OS probability vs Q0, HR (95% CI) | |
Q0a | 105 (22) | 26.9 (18.6–NE) | – | 94 (20) | 12.4 (9.5–15.0) | – |
Q1 | 107 (22) | NR (29.9–NE) | 0.63 (0.43–0.93)b | 137 (30) | 31.9 (22.1–37.8) | 0.48 (0.35–0.67)b |
Q2 | 64 (13) | NR (26.1–NE) | 0.65 (0.42–1.01)b | 109 (24) | NR (NE) | 0.21 (0.14–0.32)b |
Q3 | 96 (20) | NR (NE) | 0.22 (0.13–0.38)b | 73 (16) | NR (NE) | 0.18 (0.11–0.29)b |
Q4 | 107 (22) | NR (NE) | 0.18 (0.11–0.32)b | 46 (10) | NR (NE) | 0.08 (0.03–0.17)b |
Among Q0 pts, median OS was longer and OS probabilities were notably higher with N+I vs S.
bP < 0.0001 when compared with Q0 in the same arm. CI, confidence interval; HR, hazard ratio; NE, not estimable; NR, not reached.
Conclusions
The relationships between DepOR and OS are distinct for N+I vs S, with a greater percentage of N+I pts having prolonged OS. Similar notable OS benefits in N+I DepOR Q3 and Q4 suggest that a DepOR threshold >50% may be a useful indicator of potential for long-term survival with N+I in aRCC pts. Prospective analyses to determine clinical applications are needed.
Clinical trial identification
NCT02231749.
Editorial acknowledgement
Jen Tyson, PhD, and Lawrence Hargett of Parexel.
Legal entity responsible for the study
Bristol-Myers Squibb.
Funding
Bristol-Myers Squibb and ONO Pharmaceutical Company Limited.
Disclosure
V. Grünwald: Research grant / Funding (institution), Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Non-remunerated activity/ies: MSD; Research grant / Funding (institution), Travel / Accommodation / Expenses, Non-remunerated activity/ies: Novartis; Research grant / Funding (institution), Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options: AstraZeneca; Research grant / Funding (institution), Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Non-remunerated activity/ies: BMS; Travel / Accommodation / Expenses, Non-remunerated activity/ies: Merck Serono; Travel / Accommodation / Expenses, Non-remunerated activity/ies: Roche; Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Travel / Accommodation / Expenses: Lilly; Travel / Accommodation / Expenses, Non-remunerated activity/ies: PharmaMar; Travel / Accommodation / Expenses: Nanobiotix; Travel / Accommodation / Expenses: Janssen; Travel / Accommodation / Expenses, Non-remunerated activity/ies: Eisai; Research grant / Funding (institution), Travel / Accommodation / Expenses, Non-remunerated activity/ies: Ipsen; Research grant / Funding (institution), Travel / Accommodation / Expenses: Eusa Pharm. T.K. Choueiri: Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bayer; Honoraria (self), Research grant / Funding (self), Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Cerulean; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Eisai; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Foundation Medicine Inc; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Exelixis; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Genentech; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: GlaxoSmithKline; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Merck; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Peloton; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Prometheus Labs; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Corvus; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: IPSEN; Research grant / Funding (institution): Tracon; Research grant / Funding (institution): Astellas. B.I. Rini: Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy, Research grant / Funding (institution): GNE/Roche; Advisory / Consultancy, Research grant / Funding (institution): Peloton; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): BMS; Advisory / Consultancy, Research grant / Funding (institution): Aveo; Advisory / Consultancy: Novartis; Advisory / Consultancy: Synthorx; Advisory / Consultancy: Compugen; Advisory / Consultancy: Merck; Advisory / Consultancy: Corvus; Advisory / Consultancy: Exelixis; Shareholder / Stockholder / Stock options: PTC Therapeutics. T. Powles: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Merck; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Ipsen; Research grant / Funding (institution): Exelixis. S. George: Research grant / Funding (institution), Travel / Accommodation / Expenses: Bayer; Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Research grant / Funding (institution): Novartis; Travel / Accommodation / Expenses: Exelixis; Travel / Accommodation / Expenses: Janssen; Research grant / Funding (institution), Travel / Accommodation / Expenses: Corvus; Travel / Accommodation / Expenses: Genentech; Travel / Accommodation / Expenses: Sanofi/Genzyme; Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Research grant / Funding (institution): Acceleron; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Agensys; Research grant / Funding (institution): Eisai; Travel / Accommodation / Expenses: EMD Serono. M. Grimm: Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Travel / Accommodation / Expenses: Pfizer; Travel / Accommodation / Expenses: Bayer HealthCare; Travel / Accommodation / Expenses: Astellas; Travel / Accommodation / Expenses: Intuitive Surgical; Travel / Accommodation / Expenses: Sanofi Aventis; Travel / Accommodation / Expenses: Hexal; Travel / Accommodation / Expenses: Apogepha; Travel / Accommodation / Expenses: Amgen; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: MSD; Travel / Accommodation / Expenses: Janssen Cilag; Travel / Accommodation / Expenses: Ono Pharma; Travel / Accommodation / Expenses: IPSEN. M.B. McHenry: Shareholder / Stockholder / Stock options, Full / Part-time employment: Bristol-Myers Squibb. M. Maurer: Shareholder / Stockholder / Stock options, Full / Part-time employment: Bristol-Myers Squibb. R.J. Motzer: Research grant / Funding (institution): BMS; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Research grant / Funding (institution): Eisai; Advisory / Consultancy, Research grant / Funding (institution): Exelixis; Advisory / Consultancy, Research grant / Funding (institution): Genentech/Roche; Advisory / Consultancy: Merck; Travel / Accommodation / Expenses: Incyte; Advisory / Consultancy: Lilly. H.J. Hammers: Advisory / Consultancy, Research grant / Funding (institution): BMS; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Exelixis; Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy: Armo Biosciences; Advisory / Consultancy: Novartis. N.M. Tannir: Advisory / Consultancy, Research grant / Funding (institution): BMS; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Nektar Therapeutics; Advisory / Consultancy: Oncorena; Advisory / Consultancy, Research grant / Funding (institution): Exelixis; Advisory / Consultancy: Eisai; Research grant / Funding (institution): Calithera Bioscience; Advisory / Consultancy: Ono Pharmaceutical. L. Albiges: Advisory / Consultancy: BMS; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Novartis; Advisory / Consultancy: Ipsen; Advisory / Consultancy: MSD; Advisory / Consultancy: Roche; Advisory / Consultancy: AstraZeneca.
Resources from the same session
3073 - 1 patient 3 different advance Ca nurse’s roles: symptom management&continuum care through a joint approach in a clinical case
Presenter: Catarina Almeida
Session: Poster Display session 3
Resources:
Abstract
4527 - Identification of malnutrition risk factors in patients with cancer in the first nursing visit
Presenter: Amaia Valverde
Session: Poster Display session 3
Resources:
Abstract
2904 - Engaging Cancer Survivors, Healthcare Providers and Advocates in The Development of a Colorectal Cancer Survivorship Information Resource: A Participatory Action Research Study
Presenter: Amanda Drury
Session: Poster Display session 3
Resources:
Abstract
3435 - Medical nurses’ experiences of the care-needs of adult patients with a primary brain tumour
Presenter: Jamila Mohammed
Session: Poster Display session 3
Resources:
Abstract
857 - Feasibility and acceptability of a mHealth intervention to increase colonoscopy uptake among Chinese first-degree relatives: a pilot cluster randomized controlled trial
Presenter: Yang Bai
Session: Poster Display session 3
Resources:
Abstract
1087 - Cancer patient participation and compliance in microbiome sample collection: an oncology research nurse’s experience
Presenter: Julie Malo
Session: Poster Display session 3
Resources:
Abstract
2783 - Implementing Digital Individual Care plans for Patients with Head and Neck cancer- Challenges and opportunities
Presenter: Helena Ullgren
Session: Poster Display session 3
Resources:
Abstract
1152 - The Effect of the Short-term and Long-term Compassion Fatigue Resiliency Program on the Quality of Life, Perceived Stress and Psychological Resilience of Oncology-Hematology Nurses
Presenter: Tugba Pehlivan
Session: Poster Display session 3
Resources:
Abstract
1172 - Competing risk analyses of overall survival and cancer-specific survival in patients with orbital rhabdomyosarcoma after surgery: a large cohort study
Presenter: Yu Zhang
Session: Poster Display session 3
Resources:
Abstract
5949 - Communication of genetic information to family members in hereditary cancers and healthcare providers’ role
Presenter: Carla Pedrazzani
Session: Poster Display session 3
Resources:
Abstract