Statistics

Kidney Cancer Targeted Therapy Statistics: Trials, Outcomes, and U.S. Burden

Key U.S. kidney cancer statistics and targeted-therapy trial results, including progression-free survival, overall survival, response rates, and patient numbers.

Kidney and renal pelvis cancer is estimated to account for 80,450 new U.S. cases and 15,160 deaths in 2026. For advanced renal cell carcinoma (RCC), targeted therapies and targeted-immunotherapy combinations have produced measurable differences in progression-free survival, overall survival, and response rates in major clinical trials.

Contents

U.S. kidney cancer burden

The National Cancer Institute’s Renal Cell Cancer Treatment PDQ estimated 80,980 new kidney and renal pelvis cancer cases in the United States in 2025, along with 14,510 deaths. The SEER Kidney and Renal Pelvis Cancer Stat Facts estimated 80,450 new cases and 15,160 deaths for 2026. These are annual U.S. estimates for different years, so they should not be treated as counts from the same reporting period.

SEER estimated that kidney and renal pelvis cancer represented 3.8% of all new U.S. cancer cases in 2026 and 2.4% of all U.S. cancer deaths. It ranked seventh among estimated U.S. cancer incidence counts in 2026 and was the 12th leading cause of cancer death in the United States.

The age-adjusted incidence rate was 18.0 cases per 100,000 people per year, based on 2019–2023 data. The age-adjusted death rate was 3.4 per 100,000 people per year, based on deaths from 2020–2024. SEER also estimated that 687,999 people were living with kidney and renal pelvis cancer in the United States in 2023. This prevalence figure measures people living with a prior diagnosis, rather than new cases in one year.

Stage, survival, and diagnosis

SEER reported a 79.2% five-year relative survival rate for kidney and renal pelvis cancer, based on SEER 21 data from 2016–2022. Survival varied substantially by stage at diagnosis:

SEER stageFive-year relative survivalShare diagnosed at local stage
Localized93.6%65.6% of all cases
Regional77.6%—
Distant20.3%—
Unknown stage55.2%—

The 65.6% local-stage figure means that nearly two-thirds of kidney and renal pelvis cancers were diagnosed at the local stage in the SEER summary. The survival percentages are relative survival measures, not guarantees for an individual patient, and they describe diagnoses from the cited historical measurement period rather than a specific targeted-therapy regimen.

The median age at diagnosis was 65 years. The median age at death was 73 years. Based on 2021–2023 data, the lifetime risk of being diagnosed with kidney and renal pelvis cancer was approximately 1.8% for both men and women, as reported by SEER.

Stage-specific survival helps explain why advanced-RCC treatment trials focus on outcomes such as progression-free survival (PFS) and overall survival (OS). The distant-stage five-year relative survival rate was 20.3%, compared with 93.6% for localized disease. Those population-level figures do not show how a particular person will respond to treatment, but they provide context for evaluating results in advanced disease.

Who is affected

SEER reported that kidney and renal pelvis cancer was most frequently diagnosed among people aged 65–74, who accounted for 30.2% of new cases. People aged 55–64 accounted for 25.4%, those aged 75–84 accounted for 17.2%, and those aged 45–54 accounted for 13.7%. People younger than 20 accounted for 0.8% of new cases.

The overall male age-adjusted incidence rate was 24.4 per 100,000, compared with 12.3 per 100,000 for females. The corresponding age-adjusted death rates were 5.0 per 100,000 for males and 2.1 per 100,000 for females.

SEER’s reported incidence rates by sex and race or ethnicity were:

GroupMale incidenceFemale incidence
Hispanic25.514.9
Non-Hispanic American Indian/Alaska Native37.420.0
Non-Hispanic Asian/Pacific Islander12.75.9
Non-Hispanic Black26.813.3
Non-Hispanic White25.112.0

The reported death rates by sex and race or ethnicity were 4.7 for Hispanic males and 2.0 for Hispanic females; 9.2 for non-Hispanic American Indian/Alaska Native males and 3.8 for females; 2.4 for non-Hispanic Asian/Pacific Islander males and 1.0 for females; 4.9 for non-Hispanic Black males and 2.1 for females; and 5.3 for non-Hispanic White males and 2.2 for females. All rates in this section are per 100,000 people, as reported in the SEER summary.

First-line combination therapy trials

Several FDA-reported trials compared targeted-immunotherapy combinations with sunitinib in previously untreated or first-line advanced RCC. In KEYNOTE-426, pembrolizumab plus axitinib enrolled 861 patients. The combination had an overall-survival hazard ratio of 0.53 versus sunitinib, a 12-month overall survival rate of 90% versus 78%, and median PFS of 15.1 months versus 11.1 months.

In JAVELIN Renal 101, avelumab plus axitinib was studied in 886 patients with untreated advanced RCC. In PD-L1-positive tumors, the PFS hazard ratio was 0.61 versus sunitinib. In the total population, median PFS was 13.8 months with the combination versus 8.4 months with sunitinib.

CheckMate 9ER studied nivolumab plus cabozantinib in 651 previously untreated advanced-RCC patients: 323 were assigned to the combination and 328 to sunitinib. Median PFS was 16.6 months versus 8.3 months, with a PFS hazard ratio of 0.51. The OS hazard ratio was 0.60 versus sunitinib.

CLEAR/KEYNOTE-581 studied lenvatinib plus pembrolizumab in 712 first-line advanced-RCC patients, randomized 355 versus 357. Median PFS was 23.9 months versus 9.2 months with sunitinib. The PFS hazard ratio was 0.39, and the OS hazard ratio was 0.66.

For intermediate- or poor-risk disease, CheckMate 214 evaluated nivolumab plus ipilimumab in 847 advanced-RCC patients. The combination had an overall-survival hazard ratio of 0.63 versus sunitinib and an objective response rate (ORR) of 41.6% versus 26.5%. The regimen used nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every three weeks for four doses, followed by nivolumab monotherapy.

Other targeted-therapy comparisons

The FDA-reported METEOR study enrolled 330 patients on cabozantinib and 328 on everolimus. Cabozantinib produced median PFS of 7.4 months versus 3.8 months with everolimus, median OS of 21.4 months versus 16.5 months, and a confirmed ORR of 17% versus 3%.

In first-line advanced RCC, cabozantinib produced median PFS of 8.6 months versus 5.3 months with sunitinib. Its PFS hazard ratio versus sunitinib was 0.48.

The phase 3 TIVO-3 study evaluated tivozanib in 350 patients randomized 1:1, with 175 patients in each arm, for relapsed or refractory advanced RCC. Median PFS was 5.6 months with tivozanib versus 3.9 months with sorafenib, and the PFS hazard ratio was 0.73. The ORR was 18% versus 8%. Median OS was 16.4 months with tivozanib versus 19.2 months with sorafenib; this OS result is distinct from the PFS and response-rate comparisons and should not be interpreted as an OS advantage for tivozanib from the figures reported here.

These trials used different patient populations, treatment lines, comparators, eligibility criteria, and endpoints. Their hazard ratios, median times, and response rates therefore describe each individual trial comparison; they do not establish a single ranking across all therapies.

Belzutifan and VHL-associated RCC

Belzutifan was studied in 61 patients with von Hippel–Lindau (VHL)-associated RCC in Study 004, according to the FDA’s approval information for cancers associated with VHL disease. This patient count is a study-population figure. The supplied FDA statistic does not provide a PFS, OS, or ORR value for this study, so no treatment outcome is assigned here.

For readers comparing targeted-therapy statistics, the distinction between disease burden and trial outcomes is important. SEER’s incidence, mortality, prevalence, stage, age, and survival figures describe kidney and renal pelvis cancer in U.S. populations over stated periods. The FDA trial figures describe selected advanced-RCC populations receiving specific regimens or comparators. Keeping those contexts separate makes the numbers more useful when discussing treatment options with an oncology team.

Written by

curekidneycancer.org Editorial Team

Editorial team

curekidneycancer.org publishes practical how-to guides and educational articles with clear steps and useful context.