The Italian Medicines Agency (Aifa) has approved the reimbursement of the combination of an immunocologic drug (nivolumab) with a targeted therapy (cabozantinib) for the first-line treatment of adult patients with advanced renal cell carcinoma. This was communicated by the American Bristol Myers Squibb (Bms), recalling that 13,500 new cases of kidney cancer are estimated every year in Italy and that 144,400 people live after diagnosis. The most frequent form is that of kidney cells. In April 2021 – explains the company in a note – the European Commission had approved this new therapeutic regimen, now also available in Italy, based on the results of the phase 3 CheckMate -9ER study which demonstrated the superior efficacy of the association compared to to sunitinib for the three key endpoints: overall survival, progression-free survival, and objective response rate.
“There is a continuing need for new therapies that show a benefit in different subgroups of patients with advanced renal cell carcinoma,” he says. Giuseppe Procopio, Head of Genitourinary Medical Oncology, Irccs Foundation, National Cancer Institute of Milan – In kidney cancer, chemotherapy and radiotherapy have always been ineffective and their use is scarce. The treatment of choice for localized disease is surgery, conservative when possible. More than 50% of patients with early stage disease recover, but 30% arrive at the diagnosis already at an advanced stage and in one third the disease can recur in metastatic form after surgery. Historically, 5-year survival in advanced or metastatic disease did not exceed 13%. ”
In the CheckMate -9ER study, involving 651 patients, “nivolumab in combination with cabozantinib, a tyrosine kinase inhibitor, reduced the risk of death by 30% compared to sunitinib at a median follow-up of 2 years – reports the specialist – Median progression-free survival doubled compared to patients who received only sunitinib (17 months vs 8.3 months), as well as the objective response rate (55.7% vs 28.4%). In an exploratory analysis, the association correlated with a disease control rate, which included complete response, partial response, and stable disease, of 88.2% compared with 69.9% with sunitinib. The good tolerability profile of this combination therapy should also be highlighted “.
“Cabozantinib – underlines Procopio – creates a tumor microenvironment that makes the action of immunotherapy more effective, allowing a synergistic antitumor activity in association with nivolumab. The data from CheckMate -9ER help to strengthen the value of the association of nivolumab and cabozantinib at the forefront for patients for whom the regimen consisting of immunotherapy with a tyrosine kinase inhibitor is chosen “.
“With this approval by Aifa, patients can access a combination therapy nivolumab-cabozantinib that has shown significant survival benefits compared to sunitinib.” Cosimo Paga, Executive Country Medical Director, Bms – Immunoncology reactivates the immune system and makes it again effective in its function of suppressing cancer cells regardless of the tumor form. Today’s milestone adds to our research heritage to develop and make available new treatments for patients with advanced renal cell carcinoma. “
“We are delighted – he comments Tonia Cinquegrana, president of the National Kidney Cancer Association (Anture) – that the national regulatory body has finally approved the reimbursement of this new therapeutic option at the forefront, which is in addition to those recently approved and which greatly expand the panorama of treatment possibilities for renal cell carcinoma advanced. For these results we have to thank the scientific research, but also all the patients who agree to participate in the trials for themselves and for others. However, there are still many challenges to be faced in order to improve treatment prospects, starting with need to increase early diagnosis. There is also a quality of life problem, during and after treatment, which must always be guaranteed. It is very important for us to know that patients treated with the combination of nivolumab and cabozantinib reported, in addition to prolonged survival, significant improvements in their quality of life “.