Eisai has announced interim results from the advanced renal cell carcinoma (RCC) cohort of Study 111 of Kisplyx® (lenvatinib) in combination with MSD’s anti-PD-1 therapy, pembrolizumab (KEYTRUDA®).
The results demonstrate that the combination achieved a confirmed objective response rate 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]).
These results were presented in an oral proffered paper session 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.
Lenvatinib and pembrolizumab are not currently approved for use in combination.
Dr Chung-Han Lee, Memorial Sloan Kettering Cancer Centre, New York, and lead investigator, said: “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.”
Gary Hendler, Chairman & CEO EMEA, Chief Commercial Officer, Oncology Business Group at Eisai, said: “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.”
The Phase III CLEAR trial (NCT02811861) evaluating lenvatinib plus pembrolizumab and lenvatinib plus everolimus versus sunitinib as first-line therapy in patients with advanced RCC is currently enrolling.