Combination Data for Lenvatinib and Pembrolizumab Demonstrate Notable Response Rates for Patients with Advanced Renal Cell Carcinoma

HATFIELD, England, September 9, 2017 /PRNewswire/ --

FOR EMEA MEDICAL MEDIA ONLY - NOT FOR SWISS/AUSTRIAN JOURNALISTS 

• Updated results of advanced RCC cohort from Study 111 support continued investigation of first-line use of the combination in ongoing Phase III study (CLEAR) 
• Phase Ib/II results to be presented in an oral proffered paper session on Saturday, 9 September at 9:15 a.m. CEST at European Society for Medical Oncology (ESMO) 2017 Congress

Eisai today announced interim results from the advanced renal cell carcinoma (RCC) cohort of Study 111 of Kisplyx^® (lenvatinib) in combination with the Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside of the United States and Canada) anti-PD-1 therapy, pembrolizumab (KEYTRUDA^®). The results demonstrate that the combination achieved a confirmed objective response rate (ORR) at week 24 of 63% (95% CI: 44 - 80), and disease control rate (DCR, complete response [CR] + partial response [PR] + stable disease [SD]), a secondary endpoint, was 96% (including 33% SD [n=10]).^[1] No new safety signals were found and toxicities were managed with supportive medications, dose interruptions/reductions or drug withdrawal.^[1] These results will be presented in an oral proffered paper session today (Abstract No. 847O) at the ESMO 2017 Congress in Madrid, Spain.

Study 111 is a Phase Ib/II study exploring the potential of combination treatment with lenvatinib and pembrolizumab in patients with selected solid tumours. Interim results reported at the ESMO 2017 Congress are taken from the cohort of both treatment-naive and previously treated patients with metastatic clear cell RCC (n=30).^[1] 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 Chung-Han Lee, MD, 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."