Pembrolizumab With Bevacizumab in Metastatic Kidney Cancer
Posted: Tuesday, April 21, 2020
For patients with metastatic renal cell carcinoma, 200 mg of pembrolizumab and 15 mg/kg of bevacizumab appears safe and yielded an overall response rate of 61%, according to the multisite phase Ib/II BTCRC-GU14-003 clinical trial. Arkadiusz Z. Dudek, MD, PhD, of HealthPartners Regions Cancer Care Center, St. Paul, published the report with colleagues in the Journal of Clinical Oncology.
“The combination of pembrolizumab and bevacizumab has an acceptable toxicity profile,” the authors wrote. “It could be further tested in patient populations where tyrosine kinase inhibitors are not well tolerated and can cause early treatment discontinuation.”
The phase Ib study included 13 patients with metastatic clear cell renal cell carcinoma who had experienced disease progression after systemic therapy. Patients received 200 mg of pembrolizumab and either 10 or 15 mg/kg of bevacizumab every 3 weeks. Phase II included 48 patients who were treatment-naive. The researchers selected 15 mg/kg of bevacizumab and 200 mg of pembrolizumab as the doses for the phase II trial. The median follow-up was 28.3 months.
The overall response rate in phase II was 61%. Patients’ responses follow: 1 complete response, 2 complete responses in the target lesions, 25 partial responses, 18 responses of stable disease, and 2 unevaluable responses. The median progression-free survival was 20.7 months, and the median overall survival was not reached. The number of tumor-infiltrating T cells correlated with a higher likelihood of response.
Of 48 patients, 2 experienced grade 4 toxicities: a duodenal ulcer and hyponatremia. “The most common treatment-related grade 3 toxicities were hypertension and proteinuria,” the authors wrote.
Disclosure: The authors’ disclosures can be found at ascopubs.org.