Ramucirumab, while not completely effective, showed some antitumor activity and was well tolerated in patients with tyrosine kinase inhibitor (TKI)-resistant or intolerant metastatic renal cell carcinoma (RCC), according to data published in the journal Cancer.
Resistance to multitargeted tyrosine kinase inhibitors (TKIs) often develops in patients with RCC, which leads to the need for alternative therapies. In this single-arm, phase 2 trial, researchers evaluated the recombinant human monoclonal antibody ramucirumab, which is directed against human vascular endothelial growth factor receptor-2 (VEGF-2), as a possible treatment for patients with TKI-resistant or intolerant metastatic renal cell carcinoma.
Best objective response rate (ORR) served as the primary endpoint, while additional endpoints included disease control rate (DCR), progression-free survival (PFS), median duration of overall response, and safety.
Thirty-nine patients were included in the study, all of whom received ramucirumab as monotherapy. Fifty-nine percent of patients had previously been treated with sunitinib, 30.8% with sunitinib and sorafenib, and 10.3% with sorafenib alone.
Results revealed an ORR of 5.1%, which fell short of the primary endpoint of an ORR of at least 15%. DCR was 64.1%, median PFS was 7.1 months; and median overall survival was 24.8 months. At least 5% of patients experienced grade 3 or higher adverse events, which included grade 3 hypertension and proteinuria. One patient died from multiorgan failure, according to the data.
The researchers concluded that, although the ORR was not as high as they had hoped, ramucirumab did demonstrate antitumor activity and was generally safe and well tolerated in patients with metastatic RCC.
Ramucirumab is a recombinant human monoclonal antibody directed against human vascular endothelial growth factor receptor-2. For this study, the authors investigated the clinical efficacy and safety of ramucirumab in patients with TKI-resistant/intolerant metastatic renal cell carcinoma.