Table 1 Main characteristics and results from pivotal RCTs on tivozanib for the treatment of advanced RCC

Design

Multicentre, randomised, controlled, open-label study + one-way crossover

Multicentre, randomised, controlled, open-label study

Availability of protocol and Statistical Analysis Plan on ClinicalTrials.gov

No

Yes

No. of patients

517

350

Inclusion

Feb 2010 – Aug 2010

May 2016 – Aug 2017

Prior treatment

70% no prior treatment

30% prior systemic therapy

100% ≥ 3^rd line therapy

Investigational drug

Tivozanib: 1.5 mg once a day (3 weeks on and 1 week off)

Tivozanib: 1.5 mg once a day (3 weeks on and 1 week off)

Control Drug

Sorafenib: 400 mg twice a day (continuously)

Sorafenib: 400 mg twice a day (continuously)

PFS^a (primary endpoint)

 Median tivozanib

11.9 months

5.6 months

 Median sorafenib

9.1 months

3.9 months

 HR [95% CI]

0.80 [0.64–0.99]

0.73 [0.56–0.94]

OS (secondary endpoint)

 Median tivozanib

28.8 months

16.4 months

 Median sorafenib

29.3 months

19.7 months

 HR [95% CI]

1.25 [0.95–1.62]

0.99 [0.76–1.29]

ORR^a (secondary endpoint)

 Tivozanib

33% [27 – 39]

18% [12–24]

 Sorafenib

23% [18–29]

8% [4–13]

Reference

Motzer et al., 2013 [6]

Rini et al., 2020 [9]