Combination therapy encouraging, according to interim results

Interim results from the advanced renal cell carcinoma (RCC) cohort of a study evaluating Kisplyx (lenvatinib) in combination with Merck’s anti-PD-1 therapy, pembrolizumab (KEYTRUDA), have been announced by Eisai.

The results from the RCC cohort of Study 111 have demonstrated that the combination therapy achieved a confirmed objective response rate (ORR) at week 24 of 63% and disease control rate (DCR), a secondary endpoint, was 96%. No new safety signals were found and toxicities were managed with supportive medications, dose interruptions/reductions or drug withdrawal. Study 111 is a Phase Ib/II study looking at the potential of combination treatment with lenvatinib and pembrolizumab in patients with selected solid tumours.

“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, PhD, 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.”

“Results from this second cohort from Study 111 for lenvatinib in combination with pembrolizumab are very encouraging with high response rates among patients with a difficult-to-treat, advanced stage cancer,” added Gary Hendler, chairman & CEO EMEA, chief commercial officer, Oncology Business Group at Eisai. “These clinical data, in addition to data from the metastatic endometrial cancer cohort presented earlier this year, reinforce the importance of lenvatinib as a treatment option and its potential in combination regimens across multiple tumour types.”

These results were presented in an oral proffered paper session (Abstract No. 847O) at the ESMO 2017 Congress in Madrid, Spain.