Dr. Toni Choueiri on key takeaways from TiNivo-2 trial

In this interview, Toni K. Choueiri, MD, shares the background and key findings from the study, “Tivozanib–nivolumab vs tivozanib monotherapy in patients with renal cell carcinoma (RCC) following 1 or 2 prior therapies including an immune checkpoint inhibitor (ICI): Results of the phase III TiNivo-2 study,” which was presented at the 2024 European Society for Medical Oncology Annual Congress in Barcelona, Spain. Choueiri is the director of the Lack Center for Genitourinary Oncology at Dana-Farber Cancer Institute in Boston, Massachusetts.

Video Transcript:

The TiNivo-2 trial was a phase 3 study that asked the question of immune checkpoint blockers, PD-1, PD-L1 inhibitor, rechallenge in metastatic renal cell cancer. The design included a TKI, tivozanib, in both arms and then adding nivolumab, a PD-1 inhibitor. Again, patients should have had experienced disease progression on prior PD-1 inhibitor. This is a soaring question in the field of kidney cancer and in solid tumors in general. I don't think this was asked. We had a study last year that showed adding atezolizumab as a rechallenge to a TKI does not at all improve clinical outcomes. But here the difference [is] that we have a PD-1 inhibitor, and the last therapy was not always an immune checkpoint inhibitor.

So, the study was dead negative. PFS, OS, [and] response rate were similar in both arms. Though I would say also that the dose in the combination arm of tivozanib was lower because of earlier studies showing increased risk of grade 3/4 hypertension. Again, this is the second study of ICI, immune checkpoint inhibitor, rechallenge, both published in The Lancet 1 year apart. [They] showed that re-challenging, at least, I would say in metastatic RCC with an immune checkpoint inhibitor, should be discouraged outside some specific situations, such as a long duration from prior immune checkpoint inhibitor–the patients that were not included in TiNivo-2.

This transcription has been edited for clarity.