In patients with kidney cancer, immunotherapy with pembrolizumab, administered after surgery, has been shown to significantly increase survival, reducing the risk of death by 38% compared to placebo after more than 4 years. Important data coming from the American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium 2024, where they were discussed in an oral presentation
Kidney cancer, how to treat the disease that struck Paola Perego by Tiziana Moriconi 23 January 2024
I study
In the Phase 3 KEYNOTE-564 study, pembrolizumab was used as adjuvant therapy in patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, with and without resection of metastatic lesions. The study achieved a median observation period of more than 57 months. At 48 months, the estimated overall survival rate was 91.2% in patients treated with pembrolizumab compared to 86% in patients treated with placebo.
The risk of recurrence after surgery
In Italy, in 2023, approximately 12,700 new diagnoses of kidney cancer were estimated, 85% of which with localized disease. Among these, approximately half can be considered at intermediate-high risk of developing metastases within a few years of diagnosis, leading to a marked worsening of life expectancy despite recent progress made in the treatment of advanced forms. “These patients are those enrolled in the KEYNOTE-564 study, the first and only clinical study in the history of renal cell carcinoma treatment to have demonstrated how immunotherapy after nephrectomy reduces the risk of developing metastases, thus prolonging survival – says Roberto Iacovelli, Medical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS of Rome and Associate Professor of Medical Oncology at the Catholic University of the Sacred Heart – All this translates concretely into the possibility of healing patients. The KEYNOTE-564 study therefore represents a milestone in oncology, being the first study to have demonstrated how immunotherapy with pembrolizumab can not only cure but also help cure kidney cancer.”
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The safety profile of pembrolizumab was consistent with that observed in previous studies and no new safety signals were observed. Treatment-related adverse events resulting in discontinuation of any therapy occurred in 18.2% of patients in the pembrolizumab arm and 0.8% of patients in the placebo arm. No deaths occurred due to treatment.
Kidney cancer, the disease Michela Murgia suffered from by Tiziana Moriconi 10 August 2023
Pembrolizumab in kidney cancer: ongoing studies
Pembrolizumab is already approved as adjuvant therapy for RCC patients in the United States, European Union, Japan, and other countries around the world based on disease-free survival data first presented at the ASCO Annual Meeting in 2021. MSD, the company that produces the drug is currently working with health authorities to include overall survival data in pembrolizumab prescribing information. “The positive overall survival results from KEYNOTE-564 support the progression-free survival data that supported the approval of pembrolizumab for this indication worldwide,” said Marjorie Green, Senior Vice President and Director of Oncology, Clinical Development Global, Merck Research Laboratories – This is the second study of pembrolizumab to demonstrate a significant overall survival benefit in early disease, and these new results add to the progress we are making in early disease.” MSD has an extensive clinical development program in renal cell carcinoma, both early and advanced, using pembrolizumab as monotherapy or in combination with the drugs belzutifan, lenvatinib and quavonlimab. There are also more than 25 pivotal studies underway in different tumor types.