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The KEYMAKER-U03 study is looking at different combinations of immunotherapy and targeted therapies for the treatment of patients with clear cell kidney cancer. This study looked at how combinations of pembrolizumab (an immunotherapy infusion), lenvatinib (a VEGFR TKI targeted therapy tablet), and belzutifan (a HIF-2α targeted therapy tablet) benefitted patients with advanced kidney cancer whose previous treatment with immunotherapy or targeted therapy had failed.
62 patients were treated with pembrolizumab plus belzutifan, 64 with lenvatinib plus belzutifan, and 73 patients were treated with pembrolizumab plus lenvatinib. Patients were followed up for about a year and a half.
Nearly half of the patients responded to treatment with lenvatinib plus belzutifan, and their cancer got smaller. One patient in the group had a complete response to treatment and their cancer disappeared. The duration of this response to treatment was an average of nearly 2 years, and the time to when the treatment stopped working and the cancer started growing again was just over a year. 8 in 10 patients survived at least one year.
Patients who were treated with pembrolizumab plus belzutifan had the smallest benefit; only 2 in 10 patients responded to treatment and nearly 7 in 10 patients survived for at least one year.
6 in 10 patients had severe or life-threatening side effects to lenvatinib plus belzutifan. The pembrolizumab plus belzutifan combination was best tolerated (4 in 10 patients had severe or life-threatening side effects).
Patients treated with lenvatinib plus belzutifan had long lasting benefit from the treatment and side effects were in line with those seen in other studies. More work is needed to support the use of this treatment in routine clinical practice. A larger clinical study is currently ongoing to look at the lenvatinib plus belzutifan treatment in patients with advanced kidney cancer whose previous treatment with immunotherapy has failed.
