Kidney cancer immunotherapy statistics span national disease estimates, adjuvant treatment after surgery, and medicines used for advanced renal cell carcinoma (RCC). In the United States, the NCI estimates 80,980 new kidney and renal pelvis cancer cases and 14,510 deaths in 2025. The NCI also reports that approximately 75% of all renal cell cancer patients survive five years. These figures describe the wider disease population, while clinical-trial results below apply to specific groups, treatments, and analysis dates.
Contents
- National kidney cancer figures
- Adjuvant pembrolizumab statistics
- Pembrolizumab plus axitinib
- Avelumab plus axitinib
- Nivolumab plus ipilimumab
- Who was represented in CheckMate-214
- How to read these results
National kidney cancer figures
The NCI Renal Cell Cancer Treatment PDQ estimates 80,980 new cases of kidney and renal pelvis cancer in the United States in 2025. The same NCI source estimates 14,510 deaths in the United States during 2025. Those are annual national estimates, not counts from an immunotherapy trial and not a measure of response to a particular medicine.
The NCI reports approximately 75% five-year survival for all renal cell cancer patients. This percentage is a broad population statistic. It should not be substituted for the disease-free survival, overall survival, progression-free survival, or response results reported in individual studies, because those endpoints use different patient groups and follow-up methods.
Adjuvant pembrolizumab statistics
The FDA announced pembrolizumab’s adjuvant RCC approval on November 17, 2021. Adjuvant treatment is given after initial treatment to reduce the risk of recurrence in the population studied. The FDA approval summary describes KEYNOTE-564, which enrolled 994 RCC patients and randomized them 1:1 to pembrolizumab or placebo.
In KEYNOTE-564, pembrolizumab was administered at 200 mg intravenously every three weeks for up to one year. The FDA also identifies an RCC adjuvant dosing option of 400 mg every six weeks. These are dosing schedules from the approval information, not a recommendation for an individual patient.
The first disease-free survival (DFS) analysis recorded 109 DFS events, or 22%, in the pembrolizumab arm and 151 events, or 30%, in the placebo arm. The DFS hazard ratio was 0.68, with a 95% confidence interval from 0.53 to 0.87 and a p-value of 0.0010. Median DFS had not been reached in either arm at that analysis, so a median number of months was not available for either group.
Overall survival data were not mature at that FDA analysis: only 5% of patients had died overall. This means the available analysis was primarily a DFS comparison rather than a mature estimate of median overall survival.
The FDA reported that the most common adverse reactions occurred in at least 20% of patients. They included musculoskeletal pain, fatigue, rash, diarrhea, pruritus, and hypothyroidism. The supplied FDA approval information does not give a separate percentage for each of those reactions, so they are listed together rather than assigned unsupported individual rates.
The NCI Renal Cell Cancer Treatment PDQ discussion of KEYNOTE-564 also describes a placebo/control group of 166 patients. Only 36% of those patients received immunotherapy at relapse. This is a treatment-at-relapse figure for that cited control-group discussion; it should not be interpreted as the percentage of all kidney cancer patients who receive immunotherapy.
Pembrolizumab plus axitinib
The FDA approved pembrolizumab plus axitinib for advanced RCC on April 19, 2019. KEYNOTE-426 enrolled 861 patients with advanced RCC who had not received systemic therapy. The pembrolizumab regimen was 200 mg intravenously every three weeks plus axitinib 5 mg orally twice daily. The comparison regimen was sunitinib 50 mg orally once daily for four weeks, followed by two weeks off. Pembrolizumab could be given for a maximum of 24 months in this study.
At the interim analysis, 18% of patients had died. The overall-survival hazard ratio was 0.53, with a 95% confidence interval of 0.38 to 0.74 and a p-value below 0.0001. The 12-month overall-survival rate was 90% with pembrolizumab plus axitinib, compared with 78% with sunitinib.
Progression-free survival also favored the combination in the reported analysis. The PFS hazard ratio was 0.69, with a 95% confidence interval from 0.57 to 0.84 and a p-value of 0.0001. Median PFS was 15.1 months with pembrolizumab plus axitinib and 11.1 months with sunitinib.
| KEYNOTE-426 measure | Pembrolizumab plus axitinib | Sunitinib |
|---|---|---|
| 12-month overall survival | 90% | 78% |
| Median progression-free survival | 15.1 months | 11.1 months |
| Treatment schedule | Pembrolizumab 200 mg IV every 3 weeks; axitinib 5 mg twice daily | 50 mg daily, 4 weeks on and 2 weeks off |
The FDA reported grade 3 or 4 hepatotoxicity in 20% of patients in the KEYNOTE-426 treatment information. Hepatotoxicity led to permanent discontinuation in 13% of patients. These safety figures describe the reported trial experience and are not a prediction of an individual’s risk.
Avelumab plus axitinib
The FDA approved avelumab plus axitinib for renal cell carcinoma on May 14, 2019. JAVELIN Renal 101 enrolled 886 patients with untreated advanced RCC. Avelumab was given at 10 mg/kg intravenously every two weeks with axitinib 5 mg twice daily. The comparator was sunitinib 50 mg once daily for four weeks on and two weeks off.
In tumors that were PD-L1-positive, the PFS hazard ratio was 0.61. In the total population, the PFS hazard ratio was 0.69. In that total population, median PFS was 13.8 months with avelumab plus axitinib and 8.4 months with sunitinib.
The FDA information reports 19 months of overall-survival follow-up for JAVELIN Renal 101. At that analysis, 27% of patients in the intent-to-treat population had died. Because the reported follow-up and death percentage identify a specific analysis, they should be kept separate from the 12-month survival figures reported for KEYNOTE-426.
Grade 3 or 4 hepatotoxicity occurred in 9% of patients receiving the avelumab combination, and permanent discontinuation because of hepatotoxicity occurred in 7%. Major cardiac adverse events occurred in 7% of patients receiving avelumab plus axitinib. These adverse-event percentages are from the FDA approval information for this trial and regimen.
Nivolumab plus ipilimumab
The FDA approved nivolumab plus ipilimumab for intermediate- or poor-risk advanced RCC on April 16, 2018. The CHECKMATE-214 intermediate- and poor-risk efficacy population included 847 patients: 425 were randomized to nivolumab plus ipilimumab and 422 to sunitinib.
The immunotherapy regimen used nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every three weeks for four doses, followed by nivolumab 3 mg/kg every two weeks. In the efficacy population, 140 patients, or 32.9%, had died with nivolumab plus ipilimumab, compared with 188, or 44.5%, with sunitinib. Median overall survival was not estimable with the combination and was 25.9 months with sunitinib. The overall-survival hazard ratio was 0.63, with a 99.8% confidence interval from 0.44 to 0.89 and a p-value below 0.0001.
Confirmed objective response rate (ORR) was 41.6% with nivolumab plus ipilimumab and 26.5% with sunitinib; the ORR p-value was below 0.0001. Complete response rates were 9.4% and 1.2%, respectively. Partial response rates were 32.2% with the combination and 25.4% with sunitinib. Median duration of response was not estimable with nivolumab plus ipilimumab and was 18.2 months with sunitinib.
Progression-free survival events or deaths occurred in 228 patients, or 53.6%, with nivolumab plus ipilimumab and in 228, or 54.0%, with sunitinib. Median PFS was 11.6 months with the combination and 8.4 months with sunitinib. The PFS hazard ratio was 0.82, with a 99.1% confidence interval from 0.64 to 1.05. The FDA reported that this PFS comparison was not significant at alpha 0.009.
Who was represented in CheckMate-214
The CHECKMATE-214 population had a median age of 61 years, with an age range of 21 to 85 years. Thirty-eight percent of patients were 65 or older, and 8% were 75 or older. Patients were 73% male and 87% white. Karnofsky performance status (KPS) was 70% to 80% for 26% of patients and 90% to 100% for 74%.
The trial also randomized 249 favorable-risk patients: 125 received nivolumab plus ipilimumab and 124 received sunitinib. In this favorable-risk group, the overall-survival hazard ratio was 1.45, with a 95% confidence interval from 0.75 to 2.81. The FDA stated that efficacy of nivolumab plus ipilimumab in favorable-risk, previously untreated RCC was not established.
Patients with brain metastases, active autoimmune disease, or conditions requiring systemic immunosuppression were excluded from CHECKMATE-214. Consequently, the reported results do not directly describe every person with advanced RCC, particularly people with those excluded conditions.
How to read these results
The studies measure different outcomes. DFS concerns disease returning or a defined event after treatment; PFS concerns progression or death; OS concerns death from any cause; and ORR describes tumor responses recorded under the study criteria. A hazard ratio below 1 favored the first-listed treatment in the reported comparison, but it does not mean that the same percentage of patients benefited or that an individual outcome can be predicted from the ratio alone.
The FDA figures also come from different approval dates and trial populations: KEYNOTE-564 addressed adjuvant pembrolizumab, while KEYNOTE-426, JAVELIN Renal 101, and CHECKMATE-214 studied advanced or untreated advanced RCC. The NCI’s 2025 national estimates and approximately 75% five-year survival figure provide broad context, but they do not replace the eligibility criteria, follow-up period, comparator, and endpoint definitions used in each immunotherapy study.