AVEO Oncology and EUSA Pharma Announce Annals of Oncology Publication of Data from Phase 1b/2 TiNivo Study in Renal Cell Carcinoma

AVEO Oncology and EUSA Pharma today announced that previously reported results from the Phase 1b/2 TiNivo study of oral (PO) tivozanib, AVEO’s next-generation vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor (TKI) drug candidate, in combination with intravenous (IV) nivolumab (OPDIVO®, Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced or metastatic renal cell carcinoma (mRCC), were published in Annals of Oncology. The article, titled “TiNivo: Safety and Efficacy of Tivozanib-Nivolumab Combination Therapy in Patients with Metastatic Renal Cell Carcinoma”, is available online first via this link.

Laurence Albiges, MD, PhD, chair of the genitourinary group and vice chair of the department of cancer medicine at the Gustave Roussy Institute in Paris Said: “With a favorable tolerability profile, I believe that tivozanib holds potential to serve as a highly relevant VEGF TKI to use in combination with immunotherapy, Additionally, the combination demonstrated anti-tumor activity and extended progression free survival (PFS), suggestive of the potential for favorable durability of response. These results serve as impetus for the continued evaluation of this promising combination.”

Michael Bailey, president and chief executive officer of AVEO Said: “Evidenced by its activity, favorable tolerability profile, and its ability to significantly reduce regulatory T cells1, we believe tivozanib could serve as a VEGF TKI of choice in the immunotherapy combination setting, As we continue to execute on the DEDUCTIVE trial of tivozanib in combination with IMFINZI® (durvalumab) in hepatocellular carcinoma, we look forward to establishing next steps in the clinic for the tivozanib-nivolumab combination in mRCC.”

Lee Morley, chief executive officer of EUSA Pharma “We are pleased to see the publication of data from the TiNivo study, highlighting the favorable tolerability profile of the molecule in the setting of immuno-oncology agent combination, We continue the commercial launch of FOTIVDA® (tivozanib) in Europe for the first line treatment of RCC and are excited by the potential of tivozanib in other oncology settings.”

The Phase 1b/2 study enrolled a total of 28 patients. The Phase 2 portion of the study (n=22) was designed to assess the safety, tolerability, and anti-tumor activity of the full dose and schedule of PO tivozanib (1.5 mg/QD for 21 days followed by a 7-day rest period), as established in the Phase 1b portion of the study (n=6), in combination with IV nivolumab (240 mg every 2 weeks). The combination was generally well tolerated and showed additive or synergistic activity for objective response rate and PFS in both treatment naïve and previously treated patients with mRCC. Overall median PFS for the 25 patients treated at the study’s full dose and schedule was 18.9 months (95% CI: 16.4; NR), with a median follow-up of 19.0 months. Median PFS for previously untreated patients (n=12) was 18.9 months, while median PFS for previously treated patients (n=13) has not yet been reached as of the data cutoff date. An objective response rate (complete response + partial response) of 56% was observed, including one treatment naïve patient (1/12) achieving a complete response, and a disease control rate of 96% (complete response + partial response + stable disease) was observed. Treatment-related Grade 3/4 adverse events (AEs) were reported in 20 patients (80%). Seven patients (28%) discontinued due to treatment-related AEs. The most common treatment-related Grade 3/4 AE was hypertension, reported in 13 patients (52%). Overall, four patients (17%) experienced a dose reduction of tivozanib due to AEs.

About Tivozanib

Tivozanib is an oral, once-daily, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved as FOTIVDA® for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union and other countries in the EUSA territory. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the U.S. seeking marketing approval as a treatment for relapsed or refractory RCC. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models1 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers. Tivozanib is also being studied by partner Kyowa Kirin in non-oncology indications.

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