The first-line combination of nivolumab plus cabozantinib prolonged overall survival (OS) vs sunitinib in patients with previously untreated advanced renal cell carcinoma (RCC) with sarcomatoid features, according to an analysis of the phase 3 CheckMate 9ER trial presented at the 2021 Genitourinary Cancers Symposium.

Previously reported results from the CheckMate 9ER trial (NCT03141177) demonstrated both an OS (HR, 0.60; P =.0010) and an objective response rate (ORR; 55.7% vs 27.1%; P <.0001) benefit with the doublet therapy compared with sunitinib. This updated analysis evaluated the efficacy of the combination in patients with sarcomatoid features, which are associated with aggressive disease and poor prognoses.

The open-label study enrolled 651 patients, 75 of whom had sarcomatoid RCC. Thirty-four patients with sarcomatoid features were randomly assigned to receive nivolumab plus cabozantinib. The remaining 41 patients were administered sunitinib.


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The primary end point was progression-free survival (PFS). Secondary end points included OS, ORR, and safety.

After an extended follow-up (minimum, 16 months), nivolumab and cabozantinib resulted in a significantly higher ORR of 55.9% compared with 22.0% with sunitinib in the sarcomatoid cohort.

OS was significantly prolonged with nivolumab plus cabozantinib, with a median of not yet reached vs 19.7 months with sunitinib (HR, 0.36; 95% CI, 0.17-0.79). PFS was also prolonged, with a median of 10.3 months with the doublet regimen compared with 4.2 months with sunitinib (HR, 0.42; 95% CI, 0.23-0.74).

The ORR was similar in patients without sarcomatoid features, at 54.7% and 29.3% with the combination or sunitinib, respectively. The median OS was not yet reached in either treatment group in the subset of patients without sarcomatoid features (HR, 0.73; 95% CI, 0.54-0.98). In this population, the median PFS was 17.5 months with nivolumab plus cabozantinib compared with 9.2 months with sunitinib (HR, 0.56; 95% CI, 0.45-0.69).

“Nivolumab plus cabozantinib demonstrated improved efficacy and prolonged survival versus sunitinib in previously untreated advanced RCC patients regardless off sarcomatoid status,” concluded Robert J. Motzer, MD, who presented the findings.

Disclosures: Some of the study authors disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. For a full list of disclosures, please refer to the original study. This clinical trial was supported by Bristol Myers Squibb.

Reference

Motzer RJ, Choueiri TK, Powles T, et al. Nivolumab + cabozantinib (NIVO+CABO) versus sunitinib (SUN) for advanced renal cell carcinoma (aRCC): Outcomes by sarcomatoid histology and updated trial results with extended follow-up of CheckMate 9ER. Presented at: 2021 Genitourinary Cancers Symposium; February 11-13, 2021. Abstract 308.

This article originally appeared on Cancer Therapy Advisor