OBJECTIVES

: Nivolumab+ipilimumab (N+I) demonstrated superior efficacy and safety outcomes compared with sunitinib (S) as first-line treatment of intermediate-/poor-risk advanced or metastatic renal cell carcinoma (1L RCC) in the CheckMate 214 trial (CM-214; NCT02231749). This study estimated the number needed to treat (NNT) and number needed to harm (NNH) for N+I versus S in 1L RCC.

METHODS

: Rates of overall survival (OS), objective response (ORR) per investigator, and treatment-related grade 3/4 adverse events (AEs) over 12, 24 and 36 months were calculated using patient-level data from CM-214 (minimum follow-up: 30 months). NNTs were calculated for OS and ORR as the inverse of the absolute risk reduction between N+I and S among all randomized patients (N+I: 425; S: 422). Similarly, the NNHs were calculated for grade 3/4 AEs among all treated patients (N+I: 423; S: 416).

RESULTS

: At 12 months, one death would be prevented if 12.67 (95% CI: 7.36-45.30) patients were treated with N+I instead of S, which reduced to 9.00 patients treated (95% CI: 5.55-23.83) at 36 months. The NNT to achieve one additional responder with N+I versus S was 7.06 (95%CI: 4.88-12.76) at month 12. For every 4.13 (95% CI: 3.14-6.05) patients treated with S instead of N+I, one additional patient would have experienced a treatment-related grade 3/4 AE over 12 months.

In Spain and Portugal (PT), there are an estimated 2,582 and 526 patients with 1L RCC eligible for treatment with N+I, respectively. If all eligible patients in Spain (and PT) were treated with N+I instead of S, there would be 204 (PT=42) fewer deaths, 366 (PT=74) additional objective responders, and 624 (PT=127) fewer treatment-related grade 3/4 AEs by 12 months.

CONCLUSIONS

: The NNT/NNH analysis showed that N+I provides consistent improved clinical benefits and lower risks of grade 3/4 AEs compared with S among patients with 1L RCC.