Cancer immunotherapy statistics show a treatment field that differs substantially by cancer type, disease stage, biomarker, and study setting. Across the reported studies, immunotherapy outcomes range from measurable response rates in advanced disease to longer cancer-free or progression-free survival after treatment. The figures below come from National Cancer Institute (NCI) reports and U.S. Food and Drug Administration (FDA) approval materials, with each measurement period and population kept explicit.
Contents
- How to read these statistics
- Bladder cancer immunotherapy statistics
- Lung cancer trial outcomes
- Nasopharyngeal and kidney cancer outcomes
- Melanoma and solid-tumor treatment data
- Cutaneous squamous cell carcinoma and tumor-agnostic results
- What these numbers mean for caregivers
How to read these statistics
An overall response rate (ORR) measures the share of patients whose tumors responded according to a study’s criteria. Progression-free survival measures time without cancer worsening or death, while overall survival measures time alive after a defined starting point. These are different endpoints and should not be compared as though they were interchangeable.
Trial results also describe specific populations. A study of previously untreated metastatic melanoma does not answer the same question as a study of people whose cancer returned after surgery. Similarly, a result for a biomarker-defined tumor group may not apply to every patient with that cancer. The numbers below are therefore presented with their cancer type, treatment setting, follow-up period, and comparator whenever the source reported them.
Bladder cancer immunotherapy statistics
The NCI reported that four immunotherapy approvals for bladder cancer arrived in a short period, bringing the total number of approved immunotherapies for bladder cancer to five. The same NCI bladder cancer overview reported that metastatic bladder cancer had approximately 5% five-year survival or better. That survival figure describes metastatic disease and should not be used as a forecast for an individual person.
One NCI report described KEYNOTE-052, a study of pembrolizumab in people with bladder cancer who were not eligible for cisplatin-containing chemotherapy. The trial enrolled 370 patients and had a median follow-up of 7.8 months. The reported response rate was approximately 29%.
Another NCI report covered a high-risk bladder cancer study of pembrolizumab after treatment. The trial randomized 702 patients, and patients received pembrolizumab every three weeks for one year. After almost four years of follow-up, median cancer-free survival was 29.6 months with pembrolizumab compared with 14.2 months with observation.
The same study reported different results by PD-L1 status. Among patients with PD-L1-positive bladder tumors, median cancer-free survival was 36.9 months with pembrolizumab versus 21 months with observation. Among patients with PD-L1-negative tumors, the corresponding figures were 17.3 months and 9 months. The NCI update also stated that bladder cancer recurrence can occur in up to 50% of people after surgery.
| Bladder cancer measure | Pembrolizumab | Comparator or context |
|---|---|---|
| KEYNOTE-052 response rate | Approximately 29% | 370 patients not eligible for cisplatin |
| Median cancer-free survival, all patients | 29.6 months | 14.2 months with observation |
| Median cancer-free survival, PD-L1-positive tumors | 36.9 months | 21 months with observation |
| Median cancer-free survival, PD-L1-negative tumors | 17.3 months | 9 months with observation |
Source: NCI bladder cancer approvals; NCI high-risk bladder cancer pembrolizumab.
Lung cancer trial outcomes
In advanced non-small cell lung cancer, the NCI reported that the nivolumab approval trial enrolled 272 patients. In that trial, nivolumab cut the risk of death by 41% compared with docetaxel. Nivolumab patients lived 3.2 months longer on average than docetaxel patients. About 30% of nivolumab-treated patients were alive at two years, compared with 13% of patients treated with docetaxel.
The NCI also reported results from a phase II nivolumab trial involving 117 participants with lung cancer after platinum-based chemotherapy and at least one other prior systemic treatment. The study recorded 17 responses among 117 patients, described as a 14.5% tumor reduction or response rate. Among responders, 59% had responses lasting at least six months.
Median overall survival in that phase II trial was 8.2 months, and overall survival at one year was 40.8%. These results came from a previously treated population, so they describe a different treatment setting from a first-line study. The two-year survival comparison from the approval trial likewise reflects the specific enrolled population and its docetaxel comparator.
Nasopharyngeal and kidney cancer outcomes
The FDA approved toripalimab on October 27, 2023 as the first immunotherapy for nasopharyngeal carcinoma. The NCI report about that approval was published January 3, 2024. The approval was based on two clinical trials conducted in Asia and gave U.S. patients the first FDA-approved drug for recurrent or metastatic nasopharyngeal carcinoma.
In the JUPITER-02 toripalimab study, two-year overall survival was 78% with toripalimab compared with 65% with chemotherapy alone. At three years, overall survival was 64% with toripalimab versus 49% with chemotherapy alone. Median progression-free survival was 21.4 months with toripalimab and 8.2 months with chemotherapy alone.
The NCI kidney cancer update described an adjuvant pembrolizumab trial in which treatment lasted up to one year. At two years after adjuvant treatment, overall survival was 96% with pembrolizumab versus 94% with placebo. At three years, the figures were 94% and 89.5%; at four years, they were 91% and 86%.
At four years, recurrence-free survival was 65% with pembrolizumab compared with 57% with placebo. The NCI update stated that kidney cancer recurrence can occur in up to 50% of people after surgery. The recurrence-free survival statistic and the recurrence estimate describe related but distinct measures: one is a trial endpoint, while the other is a reported risk statement about recurrence after surgery.
| Cancer and study | Immunotherapy result | Comparator result |
|---|---|---|
| JUPITER-02, overall survival at 2 years | 78% | 65% with chemotherapy |
| JUPITER-02, overall survival at 3 years | 64% | 49% with chemotherapy |
| Kidney cancer, overall survival at 4 years | 91% | 86% with placebo |
| Kidney cancer, recurrence-free survival at 4 years | 65% | 57% with placebo |
Sources: NCI toripalimab NPC; NCI pembrolizumab kidney cancer.
Melanoma and solid-tumor treatment data
The FDA approved OPDUALAG on March 18, 2022. The treatment was studied in 714 patients with previously untreated unresectable or metastatic melanoma at 114 sites across the United States and 24 other countries. Median progression-free survival was 10.1 months with OPDUALAG versus 4.6 months with nivolumab alone.
The FDA snapshot reported progression or death in 51% of patients receiving OPDUALAG versus 59% receiving nivolumab alone. The hazard ratio for progression-free survival was 0.75. In the treatment arms, 180 of 355 patients had progression or death with OPDUALAG, compared with 211 of 359 patients in the nivolumab arm.
The OPDUALAG efficacy population included 416 men and 298 women. It included 383 patients younger than 65 and 331 patients aged 65 or older. By reported race, the population included 690 White patients, 5 Black or African American patients, 1 American Indian or Alaska Native patient, 12 patients in another category, and 7 patients whose race was not reported. These enrollment details matter when caregivers consider how closely a trial population resembles a particular patient.
The FDA approved Opdivo Qvantig on December 27, 2024 for 10 adult solid-tumor indications. The listed indications included renal cell carcinoma, melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal carcinoma, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. The count of 10 indications reflects the approval coverage described by the FDA material.
CHECKMATE-67T randomized 495 patients. In that study, ORR was 24% with subcutaneous nivolumab-hyaluronidase versus 18% with intravenous nivolumab. This result compares two ways of delivering nivolumab in the studied indication; it is not a general response rate for every solid tumor listed in the approval.
Cutaneous squamous cell carcinoma and tumor-agnostic results
The FDA approved UNLOXCYT on December 13, 2024 for cutaneous squamous cell carcinoma. The approval trial’s efficacy population included 78 patients with metastatic cutaneous squamous cell carcinoma and 31 patients with locally advanced disease. The safety population included 141 patients.
Dosing in the trial included 800 mg every two weeks in 174 patients, 1,200 mg every three weeks in 35 patients, and other doses in 14 patients. These dose-group counts describe the trial’s dosing experience and should not be read as treatment instructions.
The FDA pembrolizumab label reported response rates for MSI-H or dMMR tumors across cancer types. ORR was 36% in colorectal cancer and 46% in non-colorectal tumors. Within the same label, ORR was 50% in endometrial cancer, 39% in gastric or gastroesophageal-junction cancer, 59% in small intestinal cancer, and 4% in brain cancer.
| MSI-H or dMMR tumor group | Reported ORR |
|---|---|
| Colorectal cancer | 36% |
| Non-colorectal tumors | 46% |
| Endometrial cancer | 50% |
| Gastric or gastroesophageal-junction cancer | 39% |
| Small intestinal cancer | 59% |
| Brain cancer | 4% |
Source: FDA pembrolizumab label. These percentages are tumor-group results from the label and are not a single rate for all MSI-H or dMMR cancers.
What these numbers mean for caregivers
For caregivers, the most useful distinction is often between a response statistic and a time-based outcome. A 29% response rate in KEYNOTE-052, a 14.5% response rate in the previously treated lung cancer phase II trial, and a 24% ORR in CHECKMATE-67T each describe tumor response in a defined study population. They do not establish how long every response lasted or predict an individual outcome.
Time-based measures add another layer. In JUPITER-02, median progression-free survival was 21.4 months with toripalimab versus 8.2 months with chemotherapy alone. In OPDUALAG, median progression-free survival was 10.1 months versus 4.6 months with nivolumab alone. In high-risk bladder cancer, median cancer-free survival was 29.6 months with pembrolizumab versus 14.2 months with observation. Each measure uses a different disease, comparator, and treatment setting.
The follow-up period is equally important. The kidney cancer results were reported at two, three, and four years after adjuvant treatment, while KEYNOTE-052 had a median follow-up of 7.8 months. A short follow-up can describe early response without answering longer-term survival questions. A caregiver discussing treatment options can ask which endpoint is being quoted, how long patients were followed, whether the cancer was newly diagnosed or previously treated, and whether the reported group was defined by a biomarker such as PD-L1, MSI-H, or dMMR.
Finally, trial size and representation provide context. The reported studies ranged from 109 efficacy patients in the UNLOXCYT cutaneous squamous cell carcinoma groups to 702 randomized patients in the high-risk bladder cancer study. OPDUALAG included 714 patients across 114 sites in the United States and 24 other countries, but its reported efficacy population included 690 White patients and only 5 Black or African American patients. Such details do not invalidate a result; they help show where evidence is strong, where it is more limited, and which questions may require individualized clinical discussion.