The phase 3 KEYNOTE-564 study has demonstrated that adjuvant pembrolizumab offers a significant improvement in overall survival for patients with clear cell renal cell carcinoma (ccRCC) at high risk of recurrence post-surgery. This study is groundbreaking as it is the first phase 3 study in nearly 50 years to show improved overall survival with any adjuvant therapy in kidney cancer.
Study Overview
- Focus: Adjuvant treatment for clear cell renal cell carcinoma, a type of kidney cancer.
- Population: 994 patients with clear cell renal cancer at intermediate to high risk of recurrence, including patients within one year of surgery who had a history of metastatic disease but showed no evidence of disease.
- Main Takeaway: Pembrolizumab significantly improved overall survival compared to placebo in patients with clear cell renal cell carcinoma at increased risk of recurrence post-surgery.
Key Findings
- Patients had a median follow-up time of approximately 57 months.
- At 48 months, the estimated overall survival rate was 91.2% for the pembrolizumab group versus 86.0% for the placebo group.
- A 28% reduction in the risk of cancer recurrence was observed in patients who received pembrolizumab compared to those who received the placebo.
- Patients who received pembrolizumab had a 38% lower risk of death compared to patients in the placebo group.
- Benefits were consistent across various patient subgroups.
Side Effects
The side effects experienced by patients were predominantly autoimmune in nature, affecting various organs, consistent with what is generally observed with PD-1 inhibitors. Around 18% of the patients discontinued pembrolizumab due to these side effects, but no fatalities were directly linked to the treatment.
Expert Perspective
"Through this study, we now understand that pembrolizumab is more than just a measure to delay recurrence in kidney cancer; it is a means to significantly improve overall survival for patients," said lead study author Toni K. Choueiri, MD.
Next Steps
Building on the success of pembrolizumab in the KEYNOTE-564 study, researchers are now recruiting patients for a new trial that combines pembrolizumab with the Hypoxia-Inducible Factor-2 (HIF-2) inhibitor belzutifan.
This study represents a significant advancement in the treatment of kidney cancer, offering new hope for patients at high risk of recurrence.
