Adjuvant Keytruda Improves Kidney Cancer Survival (2024)

, by Carmen Phillips

Adjuvant Keytruda Improves Kidney Cancer Survival (1) Enlarge

The immunotherapy drug pembrolizumab (Keytruda) has rapidly become one of the most widely used cancer treatments. Based on updated results from a large clinical trial, the drug is now part of an important milestone in the treatment of kidney cancer—specifically, clear-cell renal cell carcinoma, the most common form of the disease.

All participants in the trial had earlier-stage kidney cancer and their tumors could be removed with surgery, but they were also at increased risk of their cancer coming back, or recurring. So after undergoing surgery, they were randomly assigned to get pembrolizumab for up to a year or a placebo and routine monitoring.

At 4 years after starting the post-surgical treatment, about 91% of people given pembrolizumab were still alive, compared with 86% of those who received a placebo, according to results published April 17 in the New England Journal of Medicine. Overall, people who received pembrolizumab had a nearly 40% reduced risk of dying during that period.

The findings mark the first time a post-surgical, or adjuvant, treatment for kidney cancer has been shown to help people live longer.

Based on earlier results from this trial, called KEYNOTE-564, the Food and Drug Administration (FDA) approved pembrolizumab in 2021 as an adjuvant treatment for kidney cancer. At the time of the approval, the trial had only gone on long enough to show an improvement in how long people lived without their cancer returning.

But even with the approval, many oncologists haven’t been using pembrolizumab routinely as an adjuvant treatment in their higher-risk patients, explained Martin Voss, M.D., and Robert Motzer, M.D., of Memorial Sloan Kettering Cancer Center, in an editorial that accompanied the updated findings.

Instead, they’ve been waiting to find out whether the treatment improves how long people live overall, Drs. Voss and Mosser wrote. With that question now answered, they continued, “the anticipated effect” on the everyday care of patients “cannot be overstated.”

Some experts, however, anticipate a measured change in treatment. “It’s not going to be a total paradigm shift,” said Mark Ball, M.D., of NCI’s Center for Cancer Research, who specializes in treating kidney cancer.

In part, that’s because the updated findings also show that many patients appear to do very well with surgery alone, Dr. Ball said. Giving all patients who meet the approval criteria an expensive drug that can have serious side effects, he continued, would clearly be “overtreatment.”

So from a research perspective, he said, the next steps are clear: “We have to get smarter about identifying who is at the highest risk of recurrence.”

Looking for answers to the overall survival question

Many people with earlier-stage kidney cancer are cured with surgery. But the cancer will return in up to 50% of people, most often those whose cancer has certain high-risk characteristics. Those characteristics include the presence of cancer in the lymph nodes nearest to the tumor or having tumor cells with what are called sarcomatoid features.

Adjuvant therapy is used in many early-stage cancers that can be treated with surgery. It serves as an insurance policy of sorts, reducing the chances of the cancer coming back by killing any cancer cells missed by surgery or that had already escaped from the tumor before surgery.

Form of Radiation Effective for Some People with Kidney CancerCalled SBRT, the treatment stopped tumors from growing, keeping them in check for 5 years.

Until now, only a single adjuvant therapy for kidney cancer has been available: the targeted therapy sunitinib (Sutent), which was approved by FDA for this use in 2017.

That approval was based on one clinical trial in which adjuvant sunitinib improved disease-free survival. But the improvement came with severe side effects, and there’s no evidence that the treatment helps people live longer, Dr. Ball explained.

As a result, Dr. Ball said, “sunitinib is really never prescribed” for this use.

In the absence of an adjuvant therapy that’s proven to help people with earlier-stage kidney cancer live longer, many patients only get routine monitoring, or surveillance, afterward.

So oncologists have been especially eager to see if, with more time having passed, the promising recurrence-free survival with pembrolizumab in the KEYNOTE-564 trial translated into longer overall survival.

Improved survival at 2, 3, and 4 years

Nearly 1,000 people participated in KEYNOTE-564, which was funded by Merck, pembrolizumab’s manufacturer. All were at increased risk of their cancer coming back after surgery. Participants assigned to pembrolizumab took the drug every 3 weeks for up to 1 year.

More people in the pembrolizumab group were alive at every time point measured in the study, not just at the 4-year mark.

People in the pembrolizumab group also continued to live longer without their cancer returning. At 4 years, 65% of people in the pembrolizumab group had not had a recurrence, compared with 57% in the placebo group.

Time after starting adjuvant treatmentPeople in pembrolizumab group still alivePeople in placebo group still alive
2 years96%94%
3 years94%89.5%
4 years91%86%

The findings represent “a clinically meaningful survival improvement,” said the trial’s lead investigator, Toni Choueiri, M.D., of Dana-Farber Cancer Institute in Boston, during a presentation of the results at the 2024 ASCO Genitourinary Cancer Symposium in January.

As was expected, Dr. Choueiri noted, more people in the pembrolizumab group had treatment-related side effects, including those like fatigue and rash that are commonly seen in people treated with the drug.

Overall, about 20% of people in the pembrolizumab group had serious side effects, and 21% stopped treatment early because of side effects (as did 2% of those in the placebo group).

A major shift in treating early-stage kidney cancer?

More people with early-stage RCC should now get pembrolizumab after surgery, said Pedro Barata, M.D., of the Seidman Cancer Center in Cleveland, who specializes in treating kidney cancer, at the ASCO Genitourinary Cancer Symposium.

Dr. Barata said he generally recommends adjuvant therapy with pembrolizumab to his patients at a particularly elevated risk of the cancer returning, which he assesses using a recurrence risk model for kidney cancer.

Most patients will only have mild side effects from the treatment, he continued. But “some patients will have significant side effects,” and the treatments used to manage those side effects have their own side effects.

So oncologists need to discuss the potential improvements in survival versus the impact of potential side effects, Dr. Barata continued.

“We [must] take into consideration quality of life, patient preferences, and even availability of the drug in some circ*mstances,” he said. “However, I would argue that [now] the scales favor adjuvant pembrolizumab.”

Dr. Ball agreed. Unlike with some other cancers for which pembrolizumab is a standard treatment, however, there are no tumor or blood markers (biomarkers) that single out patients whose cancer is most likely to respond to the drug.

So for the time being, he continued, oncologists should rely on well-established risk factors to guide their decision making and treatment recommendations to their patients.

Adjuvant Keytruda Improves Kidney Cancer Survival (2024)


Adjuvant Keytruda Improves Kidney Cancer Survival? ›

Overall, people who received pembrolizumab had a nearly 40% reduced risk of dying during that period. The findings mark the first time a post-surgical, or adjuvant, treatment for kidney cancer has been shown to help people live longer.

What is the overall survival of adjuvant pembrolizumab renal cell carcinoma? ›

After a median follow-up of 57.2 months, the KEYNOTE-564 study showed a significant and a clinically meaningful improvement in overall survival (OS) with an adjuvant treatment with pembrolizumab; pembrolizumab was associated with a 38% lower risk of death than placebo among patients with clear cell renal cell carcinoma ...

How successful is Keytruda with kidney cancer? ›

In addition to the adjuvant label, Keytruda is also approved alongside either Eisai's Lenvima or Pfizer's Inlyta to treat patients with newly diagnosed advanced kidney cancer. In Keynote-564, 41% of patients in the Keytruda arm and 70% of those in the placebo group received subsequent anti-PD-1/L1 therapy.

How effective is immunotherapy for renal cancer? ›

Treatment with pembrolizumab, an immunotherapy drug, after surgery significantly prolonged overall survival in patients with clear-cell renal-cell carcinoma (ccRCC) at high risk for recurrence, according to an analysis of results from the KEYNOTE-564 study.

Does Keytruda affect the kidneys? ›

Kidney problems:

Decrease in your amount of urine. Blood in your urine. Swelling of your ankles. Loss of appetite.

How much longer do you live on Keytruda? ›

At evaluation, 43% of patients (115 / 270) were alive compared to 34% of patients (93 / 272) receiving chemotherapy. Patients receiving Keytruda lived for 10.3 months (median overall survival) compared to 7.4 months with chemotherapy.

What is the prognosis for pembrolizumab? ›

With 5 years of follow-up available for KEYNOTE-024, median overall survival (OS) was 26.3 months (95% CI, 18.3–40.4), and the 5-year survival rate was 32% in the pembrolizumab arm for enrolled patients with metastatic NSCLC (PD-L1 TPS ≥50%) and no sensitizing EGFR or ALK alterations (2).

What is the number one treatment for kidney cancer? ›

Kidney cancer is most often treated with surgery, targeted therapy, immunotherapy, or a combination of these treatments. Radiation therapy and chemotherapy are occasionally used.

Can stage 4 kidney cancer go into remission? ›

While complete remission isn't impossible, there isn't enough data to suggest it's common. Treatment for stage 4 kidney cancer will depend on the size of your tumor and what other parts of your body are affected.

Can Keytruda put cancer in remission? ›

In some people, the use of Keytruda has resulted in the remission of cancer or significant tumor shrinkage.

Is immunotherapy a last resort for kidney cancer? ›

Immunotherapy is most commonly used to treat advanced or metastatic kidney cancer, while surgery, targeted therapy and other types of treatments are typically used for early-stage kidney cancer.

What is the 10 year survival rate for kidney cancer? ›

Survival for all stages of kidney cancer

around 80 out of 100 people (around 80%) survive their cancer for 1 year or more. more than 65 out of 100 people (more than 65%) survive their cancer for 5 years or more. more than 50 out of 100 people (more than 50%) survive their cancer for 10 years or more.

Can you beat Stage 4 renal cancer? ›

Typically, stage 4 or metastatic cancers are classified as distant. According to the American Cancer Society, using the Surveillance, Epidemiology, and End Results (SEER) database, the five-year relative survival rate for distant kidney or renal pelvic cancer patients is 15 percent.

What are good signs immunotherapy is working? ›

In general, a positive response to immunotherapy is measured by a shrinking or stable tumor. Although treatment side effects such as inflammation may be a sign that immunotherapy is affecting the immune system in some way, the precise link between immunotherapy side effects and treatment success is unclear.

How sick does Keytruda make you? ›

Keytruda may also cause lung inflammation. This happens as a result of overactivation of the immune system in the lungs (immune-related pneumonitis). This can lead to symptoms such as trouble breathing, cough, and low oxygen levels in the body.

Is immunotherapy hard on the kidneys? ›

Damage to the kidneys or kidney failure is uncommon, but it sometimes does occur in people receiving an immune checkpoint inhibitor. This is usually first noticed by your health care provider when they review your lab results from blood/urine tests.

What is the overall survival of pembrolizumab Lenvatinib? ›

The median progression-free survival (95% CI) was 23.9 months (95% CI, 20.8 to 27.7) with lenvatinib plus pembrolizumab and 9.2 months (95% CI, 6.0 to 11.0) with sunitinib (HR, 0.47 [95% CI, 0.38 to 0.57]).

What is the mortality rate for adjuvant chemotherapy? ›

The mortality rates 6 months after the start of adjuvant chemotherapy for each age group (≤50, 51–60, 61–70, 71–80, and >80 years) were 2.6%, 3.1%, 4.1%, 5.3%, and 7.6% respectively (Fig.

What is the overall survival of adjuvant chemotherapy patients? ›

Disease-free survival rates ranged from 71% to 77% after adjuvant chemotherapy and from 58% to 64% after surgery only; overall survival rates were 75% to 84% for adjuvant chemotherapy and 63% to 77% for surgery only.

What is the median survival for Keytruda? ›

The KEYTRUDA-pemetrexed-platinum chemotherapy combination reduced the risk of death by 40% (HR=0.60 [95% CI, 0.50-0.72]). At five years, KEYTRUDA plus pemetrexed and cisplatin or carboplatin more than doubled the median OS compared to chemotherapy alone (22.0 months versus 10.6 months);


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