Results from the phase 3 CLEAR studywere presented at the European Society of Medical Oncology (ESMO) congress in Paris last weekend. The study showed that lenvatinib (VEGF TKI) used together with pembrolizumab (immunotherapy) resulted in better survival and cancer shrinkage compared to sunitinib when used for patients with advanced kidney cancer who had not been treated before. Updated information from patients who completed 2 years of pembrolizumab plus lenvatinib treatment and continued lenvatinib treatment alone are presented.

There were 1069 patients in this study, who were treated with lenvatinib plus pembrolizumab, or sunitinib. Patients were followed up for nearly 3 years.

For patients treated with lenvatinib and pembrolizumab, the time to when the treatment stopped working and the cancer started growing again (progression-free survival) was nearly 2 years, compared to 9.2 months for sunitinib. The duration of response to treatment was longer for the patients taking lenvatinib plus pembrolizumab (26 months) compared to sunitinib (14.7 months).

Of the patients who completed 2 years of pembrolizumab plus lenvatinib treatment, most had moderate- or high-risk kidney cancer. The overall survival time for the patients who completed 2 years of combination treatment was 3 years. Of these patients, 68% had treatment-related side effects and were more likely to have a reduction in their dose of treatment (around two thirds of patients) than patients in the sunitinib group (around half of patients). However, the side effects for each treatment were not unexpected and were manageable.

71% of patients responded to treatment with lenvatinib plus pembrolizumab and their cancer got smaller compared with 36.1% for sunitinib. 17.2% of patients on the combination had a complete response to treatment (their tumour disappeared) in comparison with 4.2% for those on sunitinib. The average duration of response was 26 months with lenvatinib plus pembrolizumab compared with 14.7 months with sunitinib.

The lenvatinib plus pembrolizumab combination continues to show clinically meaningful benefit compared to sunitinib. A large proportion of patients treated with the combination completed 2 years of treatment and continued with lenvatinib treatment with ongoing clinical benefit. The results further support lenvatinib plus pembrolizumab as a potential standard of care for previously untreated advanced kidney cancer patients.

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