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Nephrectomy status does not affect benefits seen with cabozantinib in renal cell carcinoma

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CHICAGO — Cabozantinib improved PFS, objective response rate and OS compared with everolimus among patients with advanced renal cell carcinoma regardless of nephrectomy status, according to phase 3 results of the METEOR trial presented at the ASCO Annual Meeting.

“Most patients with advanced renal cell carcinoma undergo nephrectomy as curative or palliative therapy,” the researchers wrote. “Here, we report outcomes for cabozantinib [Cabometyx, Exelixis] vs. everolimus [Afinitor, Novartis] in patients with advanced renal cell carcinoma with or without prior nephrectomy.”

Nizar M. Tannir , MD, FACP, deputy department chair of genitourinary medical oncology and professor in the department of genitourinary medical oncology at The University of Texas MD Anderson Cancer Center, and colleagues enrolled 658 patients with clear cell renal cell carcinoma who had received treatment with one or more VEGF receptor tyrosine kinase inhibitor.

Researchers randomly assigned participants 1:1 to 60 mg daily cabozantinib or 10 mg daily everolimus and classified them according to Memorial Sloan Kettering Cancer Center risk criteria and the number of prior VEGFR TKIs received.

PFS, OS and ORR served as endpoints.

The majority of patients had undergone nephrectomy (85% vs. 15%); 7% of these were partial procedures.

Certain baseline characteristics — including Karnofsky performance status, risk group, time between diagnosis and enrollment, and median sum of diameters for tumor target lesions — appeared less favorable for patients who did not undergo nephrectomy. Treatment with cabozantinib resulted in longer PFS and OS than everolimus, regardless of nephrectomy status.

The nephrectomy subgroup demonstrated an HR of 0.51 (95% CI, 0.41-0.64) for PFS and 0.66 (95% CI, 0.52-0.84) for OS; patients who did not undergo nephrectomy demonstrated an HR of 0.51 (95% CI, 0.30-0.86) for PFS and 0.75 (95% CI, 0.44-1.27) for OS.

The nephrectomy subgroups in both treatment arms experienced longer median OS.

Cabozantinib conferred higher ORR — as determined by an independent radiology committee — than everolimus among patients who underwent nephrectomy (17% vs. 4%) and those who had not (21% vs. 2%).

Grade 3 and grade 4 adverse events among both subgroups appeared consistent with the safety profiles of cabozantinib and everolimus in the general population.

Cabozantinib continued to extend PFS and OS and improve ORR compared with everolimus among patients with advanced renal cell carcinoma “irrespective of nephrectomy status,” the researchers wrote.

This year’s data from the METEOR trial follows results previously presented in 2016 from the same trial.

The FDA granted breakthrough drug designation to cabozantinib in 2015 for patients with renal cell carcinoma who had received one prior therapy. – by Julia Ernst, MS

Reference:

Tannir NM, et al. Abstract 4570. Presented at: ASCO Annual Meeting; June 2-6, 2017; Chicago.

Disclosures: Tannir reports consultant or advisory roles with, as well as honoraria, travel, accommodations and expenses from Argos Therapeutics, Bristol-Myers Squibb, Calithera Biosciences, Exelixis, Nektar, Novartis and Pfizer; and research funding from Bristol-Myers Squibb, Epizyme, Exelixis, Miranti and Novartis.