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

The TiNivo-2 trial demonstrated that rechallenging ICI therapy does not improve outcomes in patients with renal cell carcinoma.

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.

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