AVEO Oncology and EUSA Pharma have announced promising results from the phase 1 portion of the TiNivo study, a phase 1/2 multicentre trial of tivozanib (Fotiva®) in combination with nivolumab (Opdivo®), an immune checkpoint (PD-1) inhibitor, for the treatment of advanced renal cell carcinoma (RCC). The results were presented at the 16th International Kidney Cancer Symposium in Miami last week by Dr Laurence Albiges, Head, Genitourinary Unit, Institute Gustave Roussy in Paris, and a lead investigator of the study.
The phase 1 portion of the trial enrolled six patients, three with previously untreated metastatic RCC and three who had received first-line treatment. Five tumours were clear cell RCC (one with sarcomatoid features) and one was papillary RCC. The combination of tivozanib and nivolumab was well tolerated, with no dose-limiting toxicities. The most common adverse events were high blood pressure (hypertension), physical weakness/lack of energy (asthenia) and decreased appetite. No serious adverse events were reported. To date, unconfirmed best response includes a 67% (4/6) partial response (PR) rate and a 100% disease control rate (PR + stable disease). Enrollment of approximately 20 patients in the phase 2 portion of the trial is ongoing.