Fig. 1 –

Kaplan-Meier curves for (A) OS ^a and (B) PFS per IRRC using RECIST version 1.1 ^b in patients without prior nephrectomy and with an evaluable primary tumor, and (C) maximum reduction in target renal tumors in all response-evaluable patients without prior nephrectomy and with an evaluable primary tumor. ^c–g BOR = best overall response; CI = confidence interval; HR = hazard ratio; IRRC = independent radiology review committee; NIVO + IPI = nivolumab plus ipilimumab; OS = overall survival; PFS = progression-free survival; RECIST = Response Evaluation Criteria in Solid Tumors; SUN = sunitinib.

^a Median (95% CI) OS was 26.1 (14–35) mo with NIVO + IPI versus 14.3 (9.7–23) mo with SUN (HR 0.63, 95% CI 0.40–1.0); there were 37 events/53 patients versus 44 events/55 patients, respectively.

^b Median (95% CI) PFS was 8.1 (5.5–21) mo with NIVO + IPI versus 11.9 (8.4–18) mo with SUN (HR 0.99, 95% CI 0.59–1.7); there were 33 events/53 patients versus 29 events/55 patients, respectively.

^c Patients with a primary tumor at baseline and one or more on-treatment tumor assessments were included.

^d Of the 108 patients without nephrectomy, 49/53 patients in the NIVO + IPI arm and 41/55 patients in the SUN arm had a primary tumor at baseline and one or more on-treatment tumor assessments.

^e Two patients (3.8%) patients in the NIVO + IPI arm versus three (5.5%) in the SUN arm had more than one evaluable target renal tumor.

^f Best reduction shown is the maximum reduction in the sum of the diameters of target renal tumors (a negative value indicates a true reduction; a positive value indicates an increase only observed over time). The horizontal reference line at +20% indicates a 20% increase and the horizontal reference line at −30% indicates a 30% reduction, both consistent with a RECIST version 1.1 response.

^g Different colored bars represent overall systemic responses (including but not limited to responses in the primary tumor) according to RECIST version 1.1.