Interim results from Study 111, a phase Ib/II clinical trial exploring the potential of a combination of lenvatinib (Kisplyx), a tyrosine kinase inhibitor (TKI), plus pembrolizumab (Keytruda), a PD-1 inhibitor, in patients with solid tumours, were presented at the European Society of Medical Oncology (ESMO) conference in Madrid, Spain this week. The results presented for both untreated and previously treated advanced renal cell carcinoma (RCC) patients showed that the combination achieved an objective response rate (ORR) of 63% after 24 weeks of treatment, and disease control rate, a secondary endpoint, was 96%. Lenvatinib and pembrolizumab are not currently approved for use in combination.
“The observed efficacy in the metastatic RCC cohort of Study 111, particularly the 83% response rate among treatment-naïve patients, provides clinical evidence of the anti-tumour activity of lenvatinib in combination with pembrolizumab in patients with RCC,” said Dr Chung-Han Lee, Memorial Sloan Kettering Cancer Centre, New York, and lead investigator. “These data are encouraging as we look to continue enrolment in the CLEAR trial, a Phase III trial evaluating the combination of this TKI and anti-PD-1 therapy in previously untreated patients with advanced RCC, and better understand how these results may translate to a larger group of patients with this type of cancer.”