Published on February 25, 2020
This phase Ib/II study was designed to evaluate the safety and efficacy of a novel immunotherapy and VEGF-directed therapy combination as first line treatment in in patients with metastatic, clear-cell RCC metastatic renal cell carcinoma (mRCC).
In the phase II part of the study,
- The primary end point was met and 60.9% of patients had tumor shrinkage, with median time on treatment of 298 days.
- Median time until the disease had progressed under the treatment was 20.7 months
- Median overall survival at 28.3 months was not reached
- PD-L1 expression in tumor had a no significant effect on the outcomes.
- Adverse events led to treatment discontinuation in 33% of patients.
- The most common treatment-related severe toxicities were Hypertension and Proteinuria.
- There were two severe toxicities: duodenal ulcer and Hyponatremia.
- The most common cause of treatment discontinuation was Proteinuria (35%) and 45% of patients suffered severe adverse effects.
The combination of 200 mg of Ketruda and a 15 mg/kg dose of Avastin given every 3 weeks is safe and active in metastatic RCC in the front-line treatment.
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On kidney cancer
The kidneys are a pair of organs that belong to the secretory system and are located in the back of the abdominal cavity. The key role of the kidneys is blood filtration, balancing the levels of salts in the body and body fluids as well as hormone production.
There are types of kidney cancer that grow slowly and even require little or no treatment, and there are aggressive types that can spread rapidly to other organs in the body and produce metastases. This condition is defined as “metastatic kidney cancer” or “stage 4 kidney cancer.”
The existing treatments do not cure stage 4 kidney cancers, hence the need for innovative and effective treatment strategies to fight the disease. The National Cancer Institute of the United States, NCI, explicitly recommends that metastatic cancer patients should consider joining the many existing medical studies around the world in order to increase their chances of therapeutic success: longevity and quality of life.
Types of cancer in the kidney
- Renal cell carcinoma, RCC, in most cases, in 90% of cases.
- Tumor transplantation cells, for example, the transient cell cancer, TCC, are present in about 10% of cases.
- Wilms’ tumor, a nephroblastoma type, is the most common malignant kidney tumor in children, especially between the ages of 15 and 19, and is probably the source of genetic mutations, such as WT1, WT2, WTX.