Few treatment options are available for patients with advanced, high-risk kidney cancer after surgical removal of the tumor.
Results of a new study presented at the 2021 ASCO Annual Meeting show that the use of immunotherapy after surgery significantly prolonged the time of cancer-free survival compared with placebo in patients with high-risk clear-cell renal-cell carcinoma (ccRCC) who have had surgery to remove the tumor, the most common type of kidney cancer.
Cancer experts consider these results as potentially practice-changing, meaning that patients with advanced, high-risk kidney cancer may soon have a new standard of care.
Partial nephrectomy (surgery to remove the tumor in a kidney) is usually done in patients with kidney cancer. Patients with intermediate-risk or high-risk advanced kidney cancer are at risk for relapse (cancer coming back), and there are few treatment options after surgery to prevent relapse.
The KEYNOTE-564 Study
In this phase 3 clinical trial called KEYNOTE-564, the use of adjuvant immunotherapy with the PD-1 inhibitor Keytruda (pembrolizumab) reduced the risk of cancer recurrence (coming back) or death by about one-third, or 32%, compared with placebo, reported Toni K. Choueiri, MD, Director of the Kidney Cancer Center in Dana-Farber Cancer Institute in Boston, Massachusetts who presented the results.
“KEYNOTE-564 is the first phase 3 study to show an improvement in disease-free survival with adjuvant immunotherapy in patients with high-risk, fully resected ccRCC, the most common type of kidney cancer,” said Dr. Choueiri. “Pembrolizumab [Keytruda] may provide a promising treatment for patients for whom there are few therapy options. KEYNOTE-564’s disease-free survival supports pembrolizumab as a potential new standard of care for patients with high-risk kidney cancer,” Dr. Choueiri noted.
Rana R. McKay, MD, Associate Professor of Medicine at the University of California San Diego, La Jolla, California, commented on the study results.
“I would argue that these data are practice-changing and represent a paradigm shift. This is the first positive phase 3 study of adjuvant immunotherapy in RCC....Given the magnitude of benefit and limited toxicity, adjuvant pembrolizumab represents a quantum leap forward for our patients and provides a new option,” Dr. McKay said.
“Despite surgery, recurrence is common in ccRCC, and should it recur, there are limited curative treatments for patients. Given the success of pembrolizumab in the KEYNOTE-564 trial, this population may soon have a new standard of care,” said ASCO Chief Medical Officer and Executive Vice President Julie R. Gralow, MD, at a press conference.
This study included 994 patients with high-risk kidney cancer who had surgery (partial nephrectomy) to remove the tumor at least 12 weeks before the study. After the surgery, the patients in the study received adjuvant immunotherapy with Keytruda or placebo.
The results showed that adjuvant therapy with Keytruda reduced the risk of cancer recurrence or death by 32% compared with placebo.
After 24 months of adjuvant therapy, 96.6% of the patients who received immunotherapy were still alive compared with 93.5% of those who received placebo; this represents a significant, 46% reduction in the risk of cancer recurrence or death.
Overall, 85.7% of patients who received immunotherapy were free of cancer at 12 months compared with only 76.2% of patients who received placebo, and 77.3% of those who received Keytruda were still free of cancer by 24 months compared with 68.1% of those who received placebo.
In all, after 2 years of therapy, 18 deaths were reported among patients who received immunotherapy with Keytruda versus 33 patients who received placebo.
The side effects reported with Keytruda were similar to those seen in other studies. As can be expected, immunotherapy is associated with more side effects than a placebo. Immunotherapy is associated with some side effects that affect the immune system and can be quite serious. No new side effects were reported in this study with Keytruda.
“Safety results were in line with expectations, and there were no new safety signals with pembrolizumab [Keytruda],” Dr. Choueiri said.
- The surgery to remove a kidney is called nephrectomy; partial nephrectomy, or removal of 1 of the kidneys, is usually done in patients with kidney cancer
- Patients with high-risk kidney cancer after removal of the tumor have very few treatment options
- In a new study, the use of adjuvant immunotherapy reduced the risk of cancer recurrence or death by 32%
- After 24 months of adjuvant therapy, 96.6% of the patients who received immunotherapy were still alive versus 93.5% of the patients who received placebo