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Combined nivolumab/axitinib treatment elicits good response in metastatic RCC

Presented by
Dr Matthew Zibelman, Fox Chase Cancer Center, PA, USA
ASCO GU 2022
Phase 1/2
Combination treatment with the immune checkpoint inhibitor nivolumab plus the tyrosine kinase inhibitor (TKI) axitinib achieved a high response rate in treatment-naïve patients with metastatic renal cell carcinoma (mRCC) in a recent phase 1/2 trial.

A combination of systemic therapy with TKIs and immune checkpoint inhibitors is an established standard of care for patients with metastatic RCC. Several trials with different combinations are currently ongoing. Dr Matthew Zibelman (Fox Chase Cancer Center, PA, USA) presented the first results of a phase 1/2 study (NCT03172754) investigating the safety and efficacy of the TKI axitinib combined with the immune checkpoint inhibitor nivolumab [1]. The trial was initiated before the results from various phase 3 studies of immune checkpoint inhibitor/TKI combinations were known.

In the phase 1 part, the recommended dose for axitinib was established at 5 mg twice daily. The phase 2 part of the trial included 2 parallel arms: treatment-naïve mRCC patients and previously treated mRCC patients. Dr Zibelman presented results from the treatment-naïve arm only, which included 44 participants. The primary endpoint of the study is objective response rate. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.

Using the IMDC risk group grading, 18 patients (40.9%) had a favourable risk, 22 patients (52.3%) had intermediate risk, and 3 patients (6.8%) had poor risk. At a median follow-up of 11.5 months, objective response rate was 59.5%, with 2.4% complete responders and 57.1% partial responders. Disease control rate was 97.6%. Median PFS was 16.4 months, and median OS was not reached (see Figure). OS rate was 87.1% at 12 months and 69.4% at 24 months.

Figure: Progression-free and overall survival of treatment-naïve patients [1]

Adverse event data was similar to published data for other immune checkpoint inhibitor/TKI combinations, with no grade 4-5 adverse events. Discontinuation of axitinib for adverse events occurred in 9 (20.5%) patients, and discontinuation of nivolumab in 8 (18.2%) patients.

Dr Zibelman concluded that “the combination of axitinib plus nivolumab for treatment-naïve patients with metastatic RCC demonstrated efficacy and safety comparable with available immune checkpoint inhibitor/TKI combinations.” He believes that it is unlikely to move to a phase 3 trial given the wealth of immune checkpoint inhibitor/TKI combinations already available in this setting.

  1. Zibelman MR, et al. A phase I/II study of nivolumab and axitinib in patients with advanced renal cell carcinoma. Abstract 291, ASCO GU 2022, 17–19 February.


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