Efficacy data for 1L aRCC CABOMETYX® (cabozantinib) monotherapy
CABOMETYX is the only single-agent TKI to deliver superior PFS vs sunitinib in 1L aRCC1,3*
CABOSUN was a phase 2, randomized, open-label, multicenter trial of CABOMETYX vs sunitinib in first-line patients with aRCC who had ≥1 IMDC risk factors (N=157).
Patients had ≥1 IMDC risk factors: IMDC intermediate- or poor-risk disease, clear-cell component, measurable disease, and ECOG PS 0-2
|CABOMETYX 60-mg QD
|Sunitinib 50-mg QD
(4 weeks on/2 weeks off)
|Treatment continued until disease progression or unacceptable toxicity|
PFS assessed by a retrospective blinded IRRC
ORR assessed by a retrospective blinded IRRC
- Tumor assessments were conducted every 12 weeks from randomization until disease progression.
- Clear-cell component
- Measurable disease, as defined by RECIST v1.1
- IMDC intermediate or poor risk (patients must have 1 or more of the following):
2 CLINICAL RISK FACTORS
|Time from diagnosis to treatment||< 1 year|
|Karnofsky performance status||< 80%|
4 LABORATORY RISK FACTORS (routine tests)
|Hemoglobin||< lower limit of normal|
|Absolute neutrophil count||> upper limit of normal|
|Platelet count||> upper limit of normal|
|Corrected calcium||> upper limit of normal|
- No prior systemic treatment
- ECOG PS of 0-2
- Adequate end-organ and marrow function with no uncontrolled significant illness
- Brain metastases if adequately treated and stable for 3 months
- IMDC intermediate or poor
- Bone metastases: presence or absence
CABOSUN Study Efficacy Data
Primary Endpoint: Median PFS1,2†
HR=0.48 (95% CI: 0.31-0.74) P=0.0008
Assessed by a retrospective blinded IRRC
Secondary Endpoints: OS and ORR1,2
risk of death
HR=0.80 (95% CI: 0.53-1.21)
(95% CI: 3.7%-17.6%)
- ORR was assessed by a retrospective blinded IRRC and all responses were partial responses.1
- The trial did not have a prespecified hypothesis for OS and ORR, and statistical testing of these endpoints was not performed.2
The only single-agent TKI with a National Comprehensive Cancer Network® (NCCN®) preferred recommendation in:
- Category 2A: 1L intermediate-/poor-risk clear-cell aRCC6
- The “preferred” designation for cabozantinib (CABOMETYX), a single-agent TKI, is based on superior efficacy, safety, and evidence6
1L=first-line; aRCC=advanced renal cell carcinoma; CI=confidence interval; ECOG PS=Eastern Cooperative Oncology Group performance status; HR=hazard ratio; IMDC=International Metastatic Renal Cell Carcinoma Database Consortium; IRRC=independent radiology review committee; NCCN=National Comprehensive Cancer Network; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; QD=once daily; RECIST=Response Evaluation Criteria in Solid Tumors; TKI=tyrosine kinase inhibitor.
- CABOMETYX® (cabozantinib) Prescribing Information. Exelixis, Inc, 2022.
- Choueiri TK, Hessel C, Halabi S, et al. Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): progression-free survival by independent review and overall survival update. Eur J Cancer. 2018;94:115-125.
- Data on file. Exelixis, Inc.
- Choueiri T, Halabi S, Sanford, B, et al. Cabozantinib versus sunitinib as initial targeted therapy for patients with metastatic renal cell carcinoma of poor or intermediate risk: the Alliance A031203 CABOSUN trial. J Clin Oncol. 2017;35(6):591-597. doi:10.1200/JCO.2016.70.7398.
- Heng DYC, Xie W, Regan MM, et al. External validation and comparison with other models of the International Metastatic Renal-Cell Carcinoma Database Consortium prognostic model: a population-based study. Lancet Oncol. 2013;14(2):141-148. doi:10.1016/S1470-2045(12)70559-4.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Kidney Cancer V.1.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed June 17, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org.