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Nivolumab monotherapy represents an alternative first-line treatment option for treatment-naïve mRCC

Presented by
Dr Michael Atkins, Georgetown Lombardi Comprehensive Cancer Center, DC, USA
ASCO GU 2022
Phase 2, HCRN GU16-260
Results from the phase 2 HCRN GU16-260 trial demonstrated monotherapy with nivolumab to be an effective alternative treatment option for treatment-naïve patients with advanced or metastatic renal cell carcinoma (mRCC). Salvage treatment with nivolumab/ipilimumab for patients who progress on nivolumab monotherapy appeared to be of limited benefit.

Nivolumab is approved for patients with VEGFR TKI-resistant RCC and the nivolumab/ipilimumab combination is approved for treatment-naïve patients with IMDC intermediate-risk and poor-risk RCC.

Dr Michael Atkins (Georgetown Lombardi Comprehensive Cancer Center, DC, USA) presented the results of the phase 2 HCRN GU16-260 trial (NCT03117309), which evaluated the efficacy and toxicity of nivolumab monotherapy in treatment-naïve RCC as well as the efficacy of nivolumab/ipilimumab salvage in patients with tumours resistant to initial nivolumab monotherapy [1]. Eligible patients with treatment-naïve RCC started nivolumab monotherapy until progressive disease, toxicity, or completion of 96 weeks of treatment (Part A). Patients with progressive disease prior to, or stable disease at 48 weeks were potentially eligible to receive salvage nivolumab/ipilimumab (4 cycles) followed by nivolumab maintenance (Part B).

A total of 123 treatment-naïve mRCC patients (28% favourable risk, 62% intermediate risk, 10% poor risk) started monotherapy with nivolumab. At a median follow-up of 27.7 months, 35 patients had gone on to Part B. Of the remaining 88 patients, 26 were still in response and 62 did not go on to Part B for various reasons.

Objective response rate (ORR) in Part A was 34.1% (favourable risk 57.1%, intermediate risk 23.6%, and poor risk 33.3%). ORR by PD-L1 status was 26.9% in PD-L1-negative patients, 50% in PD-L1 range 1-20%, and 75% in PD-L1 >20% (trend test P-value 0.002). The median duration of response to nivolumab monotherapy was 27.6 months with 26/42 responders including 17/20 (85%) with favourable risk patients remaining progression-free at data lock. Median PFS was 8.3 months (32.5 months for favourable risk, 5.4 months for intermediate risk, and 5.2 months for poor risk patients). One-year PFS rate was 75.0% for PD-L1 >20% versus 34.6% for PD-L1-negative patients (P=0.05). ORR in Part B was 11.4% (favourable risk 33.10%, intermediate risk 7.4%, and poor risk 0%).

Dr Atkins concluded that “nivolumab monotherapy represents an alternative first-line treatment option, particularly in ipilimumab or TKI averse patients, and maybe for the patients with a stable or managed auto-immune condition. Efficacy appears to correlate with tumour PD-L1 status. Salvage treatment with nivolumab/ipilimumab is frequently not feasible and of limited benefit.”

  1. Atkins MB, et al. Phase II study of nivolumab and salvage nivolumab + ipilimumab in treatment-naïve patients (pts) with advanced clear cell renal cell (HCRN GU16-260-Cohort A): Final report. Abstract 288, ASCO GU 2022, 17–19 February.


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