AVEO Oncology and EUSA Pharma have reported positive preliminary results from a Phase Ib/II trial of oral (PO) tivozanib (FOTIVDA) in combination with intravenous (IV) nivolumab (OPDIVO) for the treatment of metastatic renal cell carcinoma (mRCC).

The multicentre trial is the Phase ll portion of TiNivo study has enrolled a total of 27 patients.

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It expects to examine the safety, tolerability, and anti-tumour activity of the full dose and schedule of PO tivozanib, as established in the Phase I portion of the study, in combination with IV nivolumab.

The combination was reportedly well-tolerated by patients. However, treatment-related Grade 3/4 adverse events occurred in 44% of patients, with hypertension being the most common.

Preliminary efficacy of the study was evaluated in 14 patients treated with the full dose and schedule of PO tivozanib and IV nivolumab combination, and enrolled at least four months before the data cutoff date.

“These results open the possibility for triple-combination therapy using tivozanib, nivolumab and ipilimumab, an immune system activator targeting CTLA-4.”

Seven patients received at least one prior systemic therapy.

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AVEO observed an objective response rate was in 64% of patients, and a disease control rate in all the patients. At the time of data collection, 11 of 14 evaluable patients continued to participate in the trial.

Genitourinary Oncology Committee ex-chairman and lead investigator of the study Bernard Escudier said: “These preliminary data continue to support the rationale for choosing a high-specificity VEGF inhibitor TKI such as tivozanib, in building upon the benefit of immune checkpoint therapy in renal cancer.

“Combining VEGF TKIs and immune checkpoint inhibitors has been hampered by toxicity potentially emerging with the use of other TKIs, while minimal off-target toxicities have been observed with tivozanib in this combination.

“These results open the possibility for triple-combination therapy using tivozanib, nivolumab and ipilimumab, an immune system activator targeting CTLA-4.”