Matthew Zibelman, MD, Fox Chase Cancer Center, Philadelphia, Pennsylvania, discusses results from a phase 1/2 study, as presented at the 2025 American Society for Clinical Oncology (ASCO) Genitourinary Cancers Symposium. This study evaluated the use of nivolumab plus axitinib among patients with renal cell carcinoma who had received previous treatment. 

Transcript: 

Hi, my name is Matthew Zibelman I am a GU medical oncologist as well as the director of clinical and translational research for GU oncology at Fox Chase Cancer Center. I'm excited to talk about our recent presentation at the 2025 GU ASCO meeting regarding our study, a phase 1/2 trial of nivolumab and axitinib in patients with advanced renal cell carcinoma. 

This study was an investigator-initiated trial, started at Fox Chase Cancer Center along with several other centers. This trial was both for patients who were previously untreated and received the combination of axitinib 5 mg, BID, and nivolumab at the 4-week dosing, as well as for patients who had received prior therapy in any line. This study was started around the time as the other now established immunotherapy TKI [tyrosine kinase inhibitor] combinations that we use in renal cell carcinoma, however this study is slightly unique in that 1, obviously it was an investigator-initiated trial but 2, it allowed patients to stop therapy at the 2-year time-point which was not included as part of the larger phase 3 studies. 

What we presented at the meeting was the results from our patients in the previously-treated cohort. This is patients who received prior therapy, primarily prior TKIs, and most of which had received 1 prior line of therapy. There were 2 patients who received prior ipilimumab and nivolumab as a combination, 6 patients had received 2 or more prior lines of therapy. Patients were treated with axitinib and nivolumab in combination until progression. The primary end point was overall response rate. 

To sort of cut to the chase and get to the results, we saw an overall response rate of 26.9%, but a disease control rate of 84.6% meaning the majority of patients had achieved at least stable disease. There were 4 patients with primary clinical progression or progressive disease on imaging. The side effects were what you would expect from these similar combinations, there were no unexpected or additional toxicities. The median PFS [progression-free survival] was 15.5 months, the median overall survival was 48.4 months, about 4 years, which is excellent in this population and most notably, that we highlighted at the presentation, there were a subset of patients who were able to stop all treatment and maintained good disease control without progression for a period of time. Specifically, 4 patients completed 2 years of the combination and were able to stop both drugs. All 4 patients remain disease free, off of additional therapy with a median time off of about 2 years. Additionally, 4 patients stopped all treatment prior to 2 years for a variety of reasons and they had a median time off systemic therapy of 29.5 months and a median time to any new treatment of 18.3 months, and then 2 patients elected to stay on axitinib alone and both of those 2 patients remain on axitinib alone without new therapy or progression for median of 24.3 months. 

Overall, while this will not likely be an additional IO-TK [immuno-oncology tyrosine kinase] combination for patients with kidney cancer, we do think this underscores the potential that some patients who have excellent responses can go on to stop both therapies and maintain good disease control without progression for a significant period of time, thus avoiding visits to the doctor and the ongoing toxicities related to TKI therapy. We look forward to presenting the results of the previously untreated cohort, hopefully later this year.

Source: 

Zibelman M, Ged Y, Carducci M, et al. Results from the prior treatment cohort of a phase I/II study of nivolumab and axitinib in patients with advanced renal cell carcinoma. Presented at 2025 ASCO Genitourinary Cancers Symposium. February 13-15, 2025; San Francisco, CA. Abstract 540