A new combination immunotherapy with a tyrosine kinase inhibitor (nivolumab-cabozantinib) has been shown to be effective as a first-line treatment in patients with advanced or metastatic clear cell kidney cancer, reducing the risk of death by 40%.

This is considered in the results of an international study, in which the Vall d’Hebron Institute of Oncology (VHIO), and that it may mean the incorporation of a new treatment for these patients.

Until now, the standard treatment for this type of cancer was a drug called sunitinib.However, the positive results of the new combination in the CheckMate 9ER phase III study, which evaluated its efficacy and safety in patients diagnosed with metastatic kidney cancer, opens up new options.

This work has been highlighted in the plenary session of the congress of the European Society of Medical Oncology (ESMO), the most important professional organization in medical oncology in Europe, which this year is being held virtually due to the coronavirus.

Dr. Cristina Suárez, a medical oncologist at the Vall d’Hebron University Hospital and researcher at the Genitourinary Tumors Group of the Vall d’Hebron Institute of Oncology (VHIO), participated in the development of this study. “The importance of this study is such that it will mean the incorporation of a new first-line treatment for clear cell renal cancer “, Suárez explained.

He considered that “in addition, (the study) confirms the important role played by immunotherapy-based combinations in the first-line treatment of this type of tumors, which is a path that has already been successfully explored in three previous independent studies”.

The investigation, in which a total of 651 patients with renal cell cancer participated patients in advanced or metastatic stage who had not received any previous systemic treatment, compared the efficacy of the combination of nivolumab and cabozantinib versus sunitinib, the standard first-line therapy at the time of starting this study.

The main objective was to compare the variation in the time free of disease progression, which went from 8.3 months in standard treatment to 16.6 months in the study arm that used nivolumab plus cabozantinib, which represents a reduction in the risk of progression of 50%.

The researchers also observed other benefits, as the 40% decrease in risk of death and an improvement in the confirmed response rate to treatment, which went from 27.1% in the standard treatment group to 55.7% in the part of the study that used the combination of drugs.

“A really interesting piece of data, in addition to, of course, the increase in survival and time free from disease progression, is that 8% of the patients treated with the new treatment had a complete response compared to 4.2% observed in sunitinib treatment “, explained the researcher.

Suárez has specified that “this data, in the case of kidney cancer, is very relevant since we know from previous studies that the magnitude of the tumor response is related to the duration of said response and, ultimately, to the survival of the patient. patient”.

The new treatment also showed “a improvement in the quality of life of patients treated with nivolumab plus cabozantinib versus those who received standard treatment, “he added. The only point where the new treatment does not improve relative to the standard is related to adverse effects.

61% of the patients who took the new treatment had some type of moderate adverse event related to the medication, compared to 51% observed in the patients who continued the treatment with sunitinib.

“This is a totally expected effect, since it is reasonable to observe a greater number of adverse effects when you perform a treatment with two drugs than when only one is used, “he has considered. Suárez has pointed out that the increase in adverse effects” is very small and, in general, they were easily manageable. “

In his opinion, “we are faced with a new first-line treatment of advanced or metastatic clear cell kidney cancer “, that supposes “a clear improvement in the survival of the patients accompanied by an improvement in their quality of life”. This shows that “immunotherapy is the way forward to advance in the treatment of this type of kidney cancer”, the VHIO researcher has stated.