Eisai and Ono Pharmaceutical are planning to conduct a Phase Ib clinical trial of Lenvima (lenvatinib mesylate) in combination with Opdivo (nivolumab), as part of their collaboration agreement to jointly develop the therapy for hepatocellular carcinoma (HCC).

Eisai’s lenvatinib is an oral inhibitor of multiple receptor tyrosine kinase (RTK), kinase activities of vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF) receptors.

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Introduced in Japan by Ono in 2014, Opdivo is a PD-1 immune checkpoint inhibitor that utilises the body’s immune system to help restore anti-tumour immune response.

Planned to be conducted in Japan, the Phase Ib trial will evaluate the safety, tolerability and efficacy of the combination therapy.

Eisai oncology business group vice-president and chief medicine creation officer Dr Takashi Owa said: “Our non-clinical research has demonstrated synergistic anti-tumour activities in the Lenvima and anti-PD1 antibody combination, which are considered to be a result of an immunostimulatory response through a reduction in immunosuppressive tumour-associated macrophages and an increase in cytotoxic T-lymphocytes by Lenvima.”

"As we believe that the combination therapy may exert more excellent therapeutic efficacy compared to the monotherapy, we are very pleased to pursue the potential for developing the combination therapy of Opdivo with lenvatinib."

The firm is additionally conducting a Phase III trial of lenvatinib in separate combinations with everolimus and pembrolizumab for renal cell carcinoma and a Phase Ib/II trial in combination with pembrolizumab to treat select solid tumours.

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Ono Clinical Development vice-president executive director Hiroshi Awata said: "We have been actively engaged in the development of Opdivo not only in monotherapy, but combination therapies with other agents.

“As we believe that the combination therapy may exert more excellent therapeutic efficacy compared to the monotherapy, we are very pleased to pursue the potential for developing the combination therapy of Opdivo with lenvatinib.”

Opdivo is being further investigated by the firm in a Phase III clinical trial in Japan for treating HCC.

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