CABOMETYX® (cabozantinib) aRCC data in combination with OPDIVO® (nivolumab)

Explore data for the #1 prescribed TKI + IO in 1L aRCC

Based on IQVIA BrandImpact data as of December 2024. Subject to change without notice.¹

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CheckMate-9ER study design and baseline characteristics

Median follow-up was 18.1 months (range: 10.6-30.6 months) with an extended follow-up analysis at 67.6 months (range 60.2-80.2 months).^2,3

CheckMate-9ER: A Phase 3, randomized, head-to-head trial^2,4

An open-label trial vs sunitinib in patients with previously untreated aRCC^2,4

1:1 randomization²
(N=651)
Patients had previously untreated aRCC with a clear-cell component²
Enrollment of patients with favorable IMDC risk score limited to 25% of population^2,5

CABOMETYX 40 mg PO once daily
+ OPDIVO 240 mg IV every 2 weeks
(n=323)⁴

sunitinib 50 mg PO once daily
for 4 weeks, followed by 2 weeks off, per cycle
(n=328)⁴

Treatment until disease progression or unacceptable toxicity⁴*

Primary endpoint^4,6
PFS^†

Secondary endpoints^4,6
OS
ORR^†
Safety

Exploratory endpoint^2‡
HRQoL

Excluded patients with autoimmune disease or other medical conditions requiring systemic immunosuppression⁴
Primary analysis included a median follow-up of 18.1 months (range: 10.6-30.6 months)^2,3
Pre-planned final OS analysis was conducted at a median follow-up of 32.9 months (range: 25.4-45.4 months) after observing 271 events^4,7,8
Extended 5-year minimum follow-up analysis was conducted with a median follow-up of 67.6 months (range: 60.2-80.2 months)³

Stratification factors⁴

IMDC risk group (favorable vs intermediate vs poor)
PD-L1 tumor expression (≥1% vs <1% or indeterminate)
Geographic region (United States, Canada, and Western and Northern Europe vs rest of world)^§

The starting dose of CABOMETYX was 40 mg in CheckMate-9ER⁴

*: Tumor assessments were performed at baseline, after randomization at Week 12, then every 6 weeks until Week 60, and then every 12 weeks thereafter. Treatment beyond RECIST v1.1–defined disease progression was permitted if the patient was clinically stable and considered to be deriving clinical benefit by the investigator. OPDIVO dosing was not to exceed a total of 2 years (from cycle 1).^4,9
^†: PFS and ORR were assessed by BICR.⁴
^‡: Other exploratory endpoints included biomarkers, PK, immunogenicity, and PFS-2.^2,5
^§: Western and Northern European countries included: Czechia, Germany, Greece, Italy, Poland, Romania, Russian Federation, Spain, and the United Kingdom of Great Britain and Northern Ireland.³

Baseline characteristics were balanced across treatment arms^2,3

CheckMate-9ER included 78% of patients who were intermediate/poor risk²

	No. (%)
	CABOMETYX + OPDIVO (n=323)	sunitinib (n=328)
Age (years)²
<65	191 (59.1)	210 (64.0)
≥65	132 (40.9)	118 (36.0)
Geographic region³
US/Canada/W. Europe/N. Europe^‖	158 (48.9)	161 (49.1)
Rest of world	165 (51.1)	167 (50.9)
Karnofsky performance status³
70	14 (4.3)	18 (5.5)
80	52 (16.1)	67 (20.4)
90	110 (34.1)	112 (34.1)
100	147 (45.5)	129 (39.3)
Not reported	0	2 (0.6)
Baseline IMDC prognostic score²
Favorable	74 (22.9)	72 (22.0)
Only 22% were IMDC favorable risk²
Intermediate	188 (58.2)	188 (57.3)
Poor	61 (18.9)	68 (20.7)
78% were IMDC intermediate/poor risk²
Time from diagnosis to randomization³
<1 year	210 (65.0)	214 (65.2)
≥1 year	112 (34.7)	111 (33.8)
Not reported	1 (0.3)	3 (0.9)
Prior nephrectomy²
Yes	222 (68.7)	233 (71.0)
No	101 (31.3)	95 (29.0)
30% had primary tumor intact²(no prior nephrectomy)
Prior radiotherapy³
Yes	46 (14.2)	45 (13.7)
No	277 (85.8)	283 (86.3)
PD-L1+ status³
≥1%	81 (25.1)	81 (24.7)
<1% or indeterminate	232 (71.8)	240 (73.2)
Not reported	10 (3.1)	7 (2.1)
Sarcomatoid features³
Yes	34 (10.5)	41 (12.5)
No	279 (86.4)	278 (84.8)
Not reported	10 (3.1)	9 (2.7)
Stage at initial diagnosis³
Stage IV	167 (51.7)	173 (52.7)
Non-stage IV	150 (46.4)	148 (45.1)
Not reported	6 (1.9)	7 (2.1)
No. of metastatic sites^2¶
1	63 (19.5)	69 (21.0)
≥2	259 (80.2)	256 (78.0)
~80% had ≥2 organs with metastases²
Most common sites of metastasis²
Lung	238 (73.7)	249 (75.9)
75% had lung metastases²
Lymph node	130 (40.2)	131 (39.9)
Bone	78 (24.1)	72 (22.0)
23% had bone metastases²
Liver	73 (22.6)	53 (16.2)
19% had liver metastases²
Adrenal gland	36 (11.1)	36 (11.0)

CheckMate-9ER studied a range of patients, including those with a high burden of disease²

^‖: Western and Northern European countries included: Czechia, Germany, Greece, Italy, Poland, Romania, Russian Federation, Spain, and the United Kingdom of Great Britain and Northern Ireland.³
^¶: Data are for tumor sites defined at baseline by the investigators according to RECIST v1.1. The number of target or nontarget lesions at baseline was not reported for 1 patient in the CABOMETYX + OPDIVO group and for 3 patients in the sunitinib group.²

See Safety Data

Progression-free survival (PFS), primary endpoint^4,6

PFS doubled in the primary analysis⁴

Primary analysis in the ITT population⁴

data chart compares primary analysis PFS data for CABOMETYX® (cabozantinib) + OPDIVO® (nivolumab) vs sunitinib

Median follow-up time of 18.1 months; range: 10.6-30.6 months²

PFS was assessed by BICR⁴

Consistent results for PFS were observed across the prespecified subgroup of IMDC risk categories⁴

PFS 5-year minimum follow-up analysis³

5-YEAR MINIMUM FOLLOW-UP ANALYSIS

data chart compares extended followup PFS data for CABOMETYX® (cabozantinib) + OPDIVO® (nivolumab) vs sunitinib

Median follow-up time of 67.6 months; range: 60.2-80.2 months³

Longest available follow-up for CheckMate-9ER

Median PFS was 16.4 months with CABOMETYX + OPDIVO vs 8.3 months with sunitinib³

No formal statistical testing was conducted at the time of the updated analysis.

Overall survival (OS), secondary endpoint^4,6

OS outcomes show early and sustained separation of curves in the primary analysis²

Primary analysis

Median follow-up time of 18.1 months; range: 10.6-30.6 months²

Pre-planned final analysis of OS (median follow-up: 32.9 months; range: 25.4-45.4 months): Median OS was 37.7 months for CABOMETYX + OPDIVO (95% Cl: 35.5-NR; n=323) compared with 34.3 months for sunitinib (95% Cl: 29.0-NR; n=328); HR=0.70 (95% Cl: 0.55-0.90)^4,7,8

OS 5-year minimum follow-up analysis³

Line graph shows secondary endpoint data for extended followup of OS in CABOMETYX® (cabozantinib) + OPDIVO® (nivolumab) vs sunitinib in CheckMate-9ER study

Median follow-up time of 67.6 months; range: 60.2-80.2 months³

Longest available follow-up for CheckMate-9ER

CABOMETYX + OPDIVO had a median OS of 46.5 months vs 35.5 months with sunitinib³

No formal statistical testing was conducted at the time of the updated analysis.

Objective response rate (ORR), secondary endpoint^4,6

ORR doubled in the primary analysis⁴

Primary analysis in the ITT population⁴

bar chart compares primary analysis ORR data for CABOMETYX® (cabozantinib) + OPDIVO® (nivolumab) vs sunitinib

Median follow-up time of 18.1 months; range: 10.6-30.6 months²

ORR was assessed by BICR⁴

At the time of primary analysis, only 5.6% of patients had progressive disease with CABOMETYX + OPDIVO vs 13.7% of patients with sunitinib²^#

^#Progressive disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of 1 or more new lesions is also considered progression.)⁵

ORR 5-year minimum follow-up analysis³

5-YEAR minimum follow-up analysis

bar chart compares extended followup ORR data for CABOMETYX® (cabozantinib) + OPDIVO® (nivolumab) vs sunitinib

Median follow-up time of 67.6 months; range: 60.2-80.2 months³

Longest available follow-up for CheckMate-9ER

13.9% of patients achieved a CR with CABOMETYX + OPDIVO vs 4.6% of patients with sunitinib³

No formal statistical testing was conducted at the time of the updated analysis.

Select Important Safety Information

The full Prescribing Information for CABOMETYX includes Warnings and Precautions for: hemorrhage, perforations and fistulas, thrombotic events, hypertension and hypertensive crises, diarrhea, palmar-plantar erythrodysesthesia (PPE), hepatotoxicity, adrenal insufficiency, proteinuria, osteonecrosis of the jaw, impaired wound healing, reversible posterior leukoencephalopathy syndrome, thyroid dysfunction, hypocalcemia, and embryo-fetal toxicity.

See additional Important Safety Information below.

See Safety Data

national comprehensive cancer network® (NCCN®)
PREFERRED OPTION¹⁰

Cabozantinib (CABOMETYX) + nivolumab (OPDIVO) was the first TKI + IO regimen with an NCCN recommendation in both clear-cell and non-clear-cell aRCC¹⁰

NCCN category 1 preferred option in clear-cell RCC

Category 1, preferred option across all risk groups in 1L clear-cell RCC¹⁰
NCCN Category 1: Based upon high-level evidence (≥1 randomized phase 3 trials or high-quality, robust meta-analyses), there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate¹⁰

NCCN preferred option in non-clear-cell RCC

Category 2A, preferred option in non-clear-cell RCC¹⁰
NCCN Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate¹⁰

: NCCN makes no representations or warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. Recommendations made by NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Kidney Cancer, V.3.2025.¹⁰
: The approval of CABOMETYX with OPDIVO in 1L aRCC was based on a randomized (1:1), open-label, Phase 3 trial of CABOMETYX + OPDIVO vs sunitinib in patients with previously untreated aRCC with a clear-cell component.

Download Guidelines Flashcard

1L=first-line; aRCC=advanced renal cell carcinoma; BICR=blinded independent central review; CI=confidence interval; CR=complete response; HR=hazard ratio; HRQoL=health-related quality of life; IMDC=International Metastatic RCC Database Consortium; IO=immunotherapy; ITT=intent to treat; IV=intravenous; NR=not reached; ORR=objective response rate; OS=overall survival; PD-L1=programmed cell death ligand 1; PFS=progression-free survival; PFS-2=progression-free survival after subsequent therapy; PK=pharmacokinetics; PO=by mouth; PR=partial response; RECIST=Response Evaluation Criteria in Solid Tumors; TKI=tyrosine kinase inhibitor.

References:

Data on file. IQVIA National Prescription Audit, December 2024. Exelixis, Inc.
Choueiri TK, Powles T, Burotto M, et al; CheckMate 9ER Investigators. Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2021;384(9):829-841.
Data on file. Exelixis, Inc.
CABOMETYX® (cabozantinib) Prescribing Information. Exelixis, Inc.
Choueiri TK, Powles T, Burotto M, et al; CheckMate 9ER Investigators. Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma [protocol]. N Engl J Med. 2021;384(9):829-841.
Motzer RJ, Choueiri TK, Powles T, et al. Nivolumab plus cabozantinib versus sunitinib for advanced renal cell carcinoma: outcomes by sarcomatoid histology and updated trial results with extended follow-up of CheckMate 9ER. Poster presented at Genitourinary Cancers Symposium; February 11-13, 2021.
Motzer RJ, Powles T, Burotto M, et al. Nivolumab plus cabozantinib versus sunitinib in first-line treatment for advanced renal cell carcinoma (CheckMate 9ER): long-term follow-up results from an open-label, randomized, phase 3 trial. Lancet Oncol. 2022;23(7):888-898.
Powles T, Choueiri TK, Burotto M, et al. Final overall survival analysis and organ-specific target lesion assessments with 2-year follow-up in CheckMate 9ER: nivolumab plus cabozantinib versus sunitinib for patients with advanced renal cell carcinoma. Poster presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium; February 17-19, 2022.
OPDIVO® (nivolumab) Prescribing Information. Bristol-Myers Squibb Company; 2024.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Kidney Cancer V.3.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed January 9, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org.

CABOMETYX® (cabozantinib) aRCC data in combination with OPDIVO® (nivolumab)

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Explore data for the #1 prescribed TKI + IO in 1L aRCC