Abstract 714P
Background
Nivolumab + ipilimumab (N+I) demonstrated superior overall survival (hazard ratio [HR], 0.66; P < 0.0001) versus sunitinib (S) as first-line treatment for intermediate/poor (I/P)-risk patients (pts) with aRCC in CheckMate 214. Prior results of pt-reported outcomes (PRO) demonstrated delayed time to first deterioration (TFD) for N+I pts. Here, we present further analysis of PRO data at 42 months minimum follow-up (49 months median follow-up), including both TFD and time to confirmed deterioration (TCD), along with sensitivity analyses (SA).
Methods
1096 pts were randomized to N+I (I/P risk, 425; favorable [F] risk, 125) and S (I/P risk, 422; F risk, 124) in CheckMate 214. The NCCN/Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19), Functional Assessment of Cancer Therapy-General (FACT-G), and EQ-5D-3L instruments were administered in the study. For these instruments, TFD and TCD were analyzed using a stratified log-rank test and stratified Cox regression model. SA were performed to assess different thresholds to determine deterioration events and to assess different rules for censoring.
Results
PRO assessment completion rates were >80% in the first 193 weeks. TFD and TCD were delayed with N+I versus S in both I/P-risk pts and intention-to-treat (ITT) pts (Table). Median TFD in I/P pts was 2.2 (N+I) versus 1.0 months (S) and TCD was 7.2 (N+I) versus 2.9 months (S) for FKSI-19 total score. N+I pts had decreased risk of deterioration versus S based on all FKSI-19 scale scores (Table). Similar TFD and TCD results were observed for the FACT-G and EQ-5D-3L. Results of the SA were consistent with these results for all instruments.
Conclusions
With extended follow-up, compared to pts treated with S, N+I pts had delayed deterioration in health-related quality of life. These results were consistent across different thresholds for deterioration and censoring rules, and confirm the treatment benefit previously reported both in I/P risk and ITT pts. Table: 714P
| FKSI-19 domain | TFD, HR (95% CI) | TCD, HR (95% CI) | ||
| Risk | I/P | ITT | I/P | ITT |
| Total | 0.54 (0.46–0.63)* | 0.54 (0.47–0.63)* | 0.64 (0.54–0.77)* | 0.64 (0.55–0.74)* |
| DRS | 0.67 (0.56–0.79)* | 0.64 (0.55–0.74)* | 0.72 (0.59–0.87)* | 0.74 (0.62–0.88)* |
| DRS-physical | 0.58 (0.49–0.69)* | 0.57 (0.49–0.67)* | 0.58 (0.47–0.71)* | 0.65 (0.54–0.77)* |
| Functional well-being | 0.77 (0.66–0.91)* | 0.76 (0.66–0.88)* | 0.79 (0.66–0.94)* | 0.78 (0.66–0.91)* |
| DRS-emotional | 0.90 (0.72–1.12) | 0.89 (0.73–1.08) | 0.90 (0.69–1.18) | 0.84 (0.66–1.07) |
| Treatment side effects | 0.45 (0.38–0.53)* | 0.42 (0.36–0.49)* | 0.50 (0.42–0.59)* | 0.49 (0.42–0.57)* |
HR <1 favors N+I vs S. *P<0.01. DRS, disease-related symptoms.
Clinical trial identification
NCT02231749.
Editorial acknowledgement
Professional medical writing assistance was provided by Nicolette Belletier, PhD, of Parexel, funded by Bristol-Myers Squibb Company.
Legal entity responsible for the study
Bristol-Myers Squibb Company.
Funding
Bristol-Myers Squibb Company.
Disclosure
D. Cella: Advisory/Consultancy: Bristol-Myers Squibb; Leadership role: FACIT.org. B. Escudier: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy: Ipsen; Honoraria (self), Advisory/Consultancy: EUSA Pharma; Honoraria (self): Roche/Genentech. S.S. Saggi: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bristol Myers Squibb. S. Blum: Full/Part-time employment: Bristol Myers Squibb. F. Ejzykowicz: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bristol Myers Squibb. C. Ivanescu: Advisory/Consultancy: Bristol Myers Squibb.