Eisai has reported positive interim results from a Phase Ib/II clinical trial (Study 111) of Kisplyx (lenvatinib) in combination with Merck’s anti-PD-1 therapy pembrolizumab (Keytruda) to treat patients with advanced renal cell carcinoma (RCC).

Lenvatinib is being developed as an oral multikinase inhibitor of vascular endothelial growth factor receptor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor-alpha, and RET and KIT proto-oncogenes.

The combination therapy is reported to have demonstrated 63% of confirmed objective response rate (ORR) at week 24 and also achieved a secondary endpoint with 96% disease control rate (DCR).

Eisai presented these results at the European Society for Medical Oncology (ESMO) 2017 Congress held in Madrid, Spain.

The multi-centre, open-label, single-arm Phase Ib/II trial evaluated 20mg a day of lenvatinib in combination with 200mg intravenous pembrolizumab for every three weeks.

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While the primary endpoint of the Phase Ib part was maximum tolerated dose of the combination, the Phase II part measured ORR at week 24.

The secondary endpoints included progression-free survival, duration of response, DCR and clinical benefit rate.

"Results from this second cohort from Study 111 for lenvatinib in combination with pembrolizumab are very encouraging,"

Eisai Oncology business group chairman, EMEA CEO and chief commercial officer Gary Hendler said: "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.

"This 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 Study 111 trial results further showed that ORR measured after week 24 was consistent with that observed at week 24, while median PFS was not achieved at follow up of 9.7 months.

Diarrhoea, fatigue, hypothyroidism, stomatitis, nausea and hypertension were found to be the common treatment-emergent adverse events (TEAEs) for the combination.

Image: Eisai head office in Tokyo, Japan. Photo: courtesy of KW at Japanese Wikipedia.