Tivozanib added to NCCN guidelines for renal cell carcinoma


Tivozanib (Fotivda) has been added to the National Comprehensive Cancer Network (NCCN) guidelines for use as a subsequent therapy following first-line treatment recommendations for patients with clear cell renal cell carcinoma (RCC), according to AVEO Oncology, the developer of the oral, next-generation VEGF tyrosine kinase inhibitor.1

The FDA approved tivozanib on March 10, 2021,2 for the treatment of adult patients with relapsed or refractory advanced RCC who have received 2 or more prior systemic therapies, based on data from the phase 3 TIVO-3 trial.

Results from TIVO-3 presented during the 2020 ASCO Virtual Scientific Program3 showed that treatment with tivozanib led to a significant improvement in progression-free survival (PFS) compared with sorafenib (Nexavar), with similar overall survival (OS), in patients with relapsed/refractory metastatic RCC.

The findings showed that the final hazard ratio (HR) for OS was 0.97 (P = .78). Moreover, an updated analysis of the data found that, with a median follow-up of 38 months for tivozanib and 40 months for sorafenib, the median OS was 16.4 months for tivozanib and 19.2 months for sorafenib. A subset analysis showed the greatest benefit was derived by the cohort of patients who previously received a checkpoint inhibitor and VEGF inhibitor, with an HR of 0.55, or 2 VEGF TKIs, with an HR of 0.57.

Prior findings showed an increased median PFS for tivozanib when compared with sorafenib at 5.6 months versus 3.9 months, respectively (HR, 0.73; P = .016).

“Fotivda’s addition to the NCCN Guidelines provides further validation for its potential to serve as an important evidence-based, well tolerated treatment option for patients with relapsed or refractory advanced RCC,” Michael Bailey, president and chief executive officer of AVEO, stated in a press release. “As previously announced, launch efforts are now underway, and we are committed to bringing this promising therapy to as many appropriate patients as possible."

In the multicenter, open-label, randomized TIVO-3 trial, 350 patients were split evenly between the 2 drugs and stratified by International Metastatic Renal Cell Carcinoma Database Consortium risk category and type of previous therapy.3 These patients had to progress on 2 or 3 prior systemic regimens, at least 1 of which had to be a VEGFR tyrosine kinase inhibitor other than sorafenib or tivozanib.

Patients either received 1.5 mg of tivozanib mg orally once a day on 4-week cycles or sorafenib at 400 mg orally twice a day continuously. The primary end point was PFS by independent review in the intention-to-treat population.

The most common grade 3/4 treatment-related adverse events (TRAEs) in the originally published data were hypertension in 20% of patients receiving tivozanib and 14% of patients receiving sorafenib. Serious TRAEs were observed in 11% versus 10% of patients respectively, but no treatment-related deaths were reported.

Tivozanib is now being explored in ongoing combination trials. For example, the phase 3 TiNivo-2 trial is exploring the VEGF-TKI in combination with the PD-1 inhibitor nivolumab (Opdivo) in patients with relapsed/refractory RCC.4


1. AVEO Oncology Announces Addition of FOTIVDA® (tivozanib) into National Comprehensive Cancer Network Clinical Practice Guidelines. Published online March 29, 2021. Accessed March 29, 2021. https://bwnews.pr/3w9zecY.

2. AVEO Oncology Announces U.S. FDA Approval of FOTIVDA® (tivozanib) for the Treatment of Adult Patients with Relapsed or Refractory Advanced Renal Cell Carcinoma. Published online March 10, 2021. Accessed March 10, 2021. https://bwnews.pr/3vbdRY4.

3. Pal SK, Escudier B, Atkins MB, et al. TIVO-3: Final OS analysis of a phase III, randomized, controlled, multicenter, open-label study to compare tivozanib to sorafenib in subjects with metastatic renal cell carcinoma (RCC). Presented at: 2020 ASCO Virtual Program; May 27, 2020. Abstract 5062.

4. AVEO Oncology Announces Collaboration with Bristol Myers Squibb to Evaluate FOTIVDA® (tivozanib) in Combination with OPDIVO® (nivolumab) in Pivotal Phase 3 TiNivo-2 Trial in IO Relapsed Renal Cell Carcinoma. Posted online March 12, 2021. Accessed March 12, 2021. https://bit.ly/3ldIasp

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