Pal Discusses Eye-Catching ASCO GU Data in RCC

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In today’s episode, sponsored by Aveo Oncology, Sumanta K. Pal, MD, FASCO, a professor in the Department of Medical Oncology & Therapeutics Research and codirector of the kidney cancer program at City of Hope, walks us through research presented at the 2022 Genitourinary Cancers Symposium, including data from the TIVO-3 trial (NCT02627963) and findings from the NeoAvAx trial (NCT03341845) exploring avelumab (Bavencio) plus axitinib (Inlyta) for patients with high-risk, nonmetastatic clear-cell renal cell carcinoma (RCC).

TIVO-3 compared tivozanib (Fotivda) vs sorafenib (Nexavar) for patients with advanced RCC who have received at least 2 prior systemic therapies. It is one of the few trials to analyze patients in the refractory setting.

Pal, a coauthor on TIVO-3, said that the odds of experiencing long-term progression-free survival (PFS) was 5 times greater for patients randomized to tivozanib. At 3 years, long-term PFS rates were 12.3% (95% CI, 8%-18%) for tivozanib vs 2.4% (95% CI, 1%-6%) with sorafenib. Tivozanib remained superior to sorafenib at 4 years, with PFS rates of 7.6% (95% CI, 4%-13%) and 0%, respectively.

Pal added that the data at 3 and 4 years was “incredibly impressive” and unexpected in refractory patients. Tivozanib, he said, should be considered for third-line therapy and added it is reasonable to consider the VEGF TKI in the second-line setting for some patients.

Pal went on to say he is excited about the possibility of neoadjuvant therapy in RCC. He was particularly intrigued by data from the NeoAvAx trial presented Axel Bex, MD, PhD. In that open-label, single-arm phase 2 trial, neoadjuvant avelumab/axitinib induced a partial response in 30% of patients (n = 12 of 40). Median primary tumor downsizing was 20% (range, +3.8%­ to 43.5%). Ten of the responding patients remained disease free at the data cutoff.

The field of RCC, he said, could be headed to even more aggressive therapy as investigators explore triplet combinations. Pal added that it will be important to consider quality of life when making treatment decisions and conducting clinical trials.

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