Nivolumab Plus Cabozantinib Improves Outcome Compared To Sunitinib In Patients With Advanced Renal Carcinoma And Bone Metastases

In patients with advanced renal cell carcinoma (aRCC) and bone metastases, treatment with first-line nivolumab plus cabozantinib improved progression-free survival (PFS), overall survival (OS), and objective response rate ( ORR) compared to treatment with sunitinib, according to research presented at the International Kidney Cancer Symposium (IKCS) 2021.

Investigators conducted a post-hoc exploratory analysis of results by baseline bone metastasis status (by investigator) in patient subgroups from the Phase 3 CheckMate 9ER trial ( Identifier: NCT03141177), which previously had demonstrated the efficacy benefits of nivolumab plus cabozantinib vs sunitinib in first-line aRCCs.

A total of 651 patients with clear cell aRCC were randomized (1: 1) to receive nivolumab plus cabozantinib (240 mg Q2W; 40 mg QD) or sunitinib (50 mg QD for 4 weeks of 6 week cycles) . PFS and ORR were assessed by an independent, blinded central review. The data cut-off date was September 10, 2020. The median follow-up time was 23.5 months (range, 16.0-36.0).

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A total of 151 patients had bone metastases at baseline, 79 in the nivolumab plus cabozantinib arm and 72 in the sunitinib arm (patients without baseline bone metastasis: n = 244 nivolumab plus cabozantinib, n = 256 sunitinib). In all subgroups, the median age was 61 to 63 years (range, 29-90), and patients were predominantly Caucasian (79% to 90%) and male (70% to 77% ).

Regardless of the bone metastasis, the ORR was higher with nivolumab plus cabozantinib than with sunitinib (with bone metastasis: 48% vs. 11%; without bone metastasis: 57% vs. 33%). The duration of the objective response was longer with nivolumab plus cabozantinib compared to sunitinib (with bone metastasis: 18% vs. 7%; without bone metastasis: 22% vs. 13%).

PFS was longer with nivolumab plus cabozantinib than with sunitinib in patients with bone metastases (18.2 months vs. 4.4 months; risk ratio [HR], 0.38; 95% confidence interval [CI], 0.25-0.59) and without bone metastasis (17 vs. 9.5 months; RR: 0.57; 95% CI: 0.45-0.72). The RR for OS was also in favor of nivolumab plus cabozantinib over sunitinib in patients with (RR: 0.64; 95% CI: 0.39-1.06) or without bone metastasis (RR: 0, 65; 95% CI: 0.46 to 0.91). The median duration of treatment was longer with nivolumab plus cabozantinib compared to sunitinib regardless of the subgroup (with bone metastasis: 16.2 vs 5.8 months; without bone metastasis: 18.6 vs 10.4 months) .

With nivolumab plus cabozantinib vs sunitinib, all-cause grade 3-4 adverse events in patients with bone metastases were 78% versus 67% and in those without bone metastasis 71% versus 68%, respectively; Treatment-related grade 3 to 4 adverse events were 71% versus 42% and 59% versus 55%, respectively.

“In this post-hoc exploratory analysis, the treatment with [nivolumab plus cabozantinib] vs [sunitinib] improved PFS, OS and ORR in patients with first-line aRCC, regardless of baseline bone metastases, consistent with results reported in all randomized patients, ”the researchers concluded.

Disclosure: This research was sponsored by Bristol Myers Squibb (Princeton, NJ, USA) in conjunction with Exelixis, Inc. (Alameda, CA, USA), Ipsen Pharma (Paris, France), Ono Pharmaceutical Company Ltd. (Osaka, Japan) and Takeda Pharmaceutical (Osaka, Japan). Please see the original reference for a full list of author disclosures.

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Apolo A, Powles T, Bourlon MT, et al. Nivolumab plus cabozantinib (N + C) versus sunitinib (S) in patients with advanced renal cell carcinoma (aRCC) and bone metastases: subgroup analysis of the phase 3 CheckMate 9ER trial. Presented at IKCS 2021; November 5-6, 2021. Summary N22.

This article originally appeared on Renal and Urology News

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