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The results from an extended follow-up of the phase 1b COSMIC-021 study, looking at the combination of cabozantinib plus atezolizumab for patients with non-clear cell kidney cancer, were presented at the American Society of Clinical Oncology Genitourinary (ASCO GU) conference in March this year.
The COSMIC-021 phase 1b study, which looked at the combination of cabozantinib plus atezolizumab in advanced solid tumours, showed encouraging clinical activity in patients with advanced non-clear cell kidney cancer after an average follow-up of 13 months. Results after a longer follow up of just over 3 years in non-clear cell kidney cancer were presented (and have been published).
Non-clear cell kidney cancer patients with untreated advanced disease or patients who had been previously treated with one course of a tyrosine kinase inhibitor (TKI) were enrolled in the study. Those patients who had been previously treated with cabozantinib were not allowed in the study. Patients were treated with a combination of cabozantinib plus atezolizumab until they were not able to tolerate the treatment or their cancer got worse. Patients were followed in the study for just over 3 years.
The proportion of patients who were on treatment and their cancer did not get worse (progression-free survival, PFS) and the proportion of patients alive after 12 months of follow-up were 34% and 84%, respectively. After 2 years of follow-up, these had dropped to 6% and 70%, respectively.
Generally, this combination was well tolerated, although 97% of patients had side effects to treatment, 53% of which were serious or life-threatening. The most common side effects included diarrhoea (69%), sore hands and feet (50%), fatigue (44%), a distorted sense of taste (41%), high blood pressure (31%) and nausea (31%). One patient died as a result of bleeding in the lungs and treatment was stopped in 13% of patients because of intolerable side effects.
This extended 3-year follow-up of the COSMIC-021 study reinforces the effectiveness of cabozantinib plus atezolizumab in advanced non-clear cell kidney cancer with manageable side effects.