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Nivolumab for Advanced Renal Cell Carcinoma: 5-Year Survival

By: Anna Nowogrodzki
Posted: Wednesday, August 14, 2019

Patients with advanced renal cell carcinoma treated with nivolumab alone had a 5-year overall survival rate of 27.7%, according to long-term follow-up data from a phase I trial. The research was published in JAMA Oncology by Suzanne Topalian, MD, of the Johns Hopkins Bloomberg–Kimmel Institute for Cancer Immunotherapy, and colleagues.

“We report, to our knowledge, the longest combined clinical follow-up for patients with multiple cancer types receiving any anti–PD-L1 drug,” the authors wrote. 

The phase I dose-escalation trial plus expansion cohort included 34 patients with advanced renal cell carcinoma and 236 patients with lung cancer or melanoma. Patients had received at least one previous treatment, and 72% had received between two and five previous treatments. Patients were enrolled between 2008 and 2011. Clinicians gave patients 0.1, 0.3, 1.0, 3.0, or 10.0 mg/kg of nivolumab every 2 weeks for up to 96 weeks or until progressive disease, complete response, toxicity, or patient withdrawal from the trial.

The median overall survival was 22.4 months. At 3 years, the overall survival rate was 40.1%, and at 5 years, it was 27.7%.

In an analysis that also included the trial’s patients with lung cancer and melanoma, pretreatment liver and bone metastases were independently associated with poorer overall survival. In contrast, an Eastern Cooperative Oncology Group performance status of 0 was associated with better survival. Overall survival was longer for those with treatment-related adverse events (median overall survival of 19.8 months) than for those with no such adverse events (median overall survival of 5.8 months). The authors also suggested that objective tumor regression may be “an early surrogate for long-term clinical benefit,” because it was associated with 5-year overall survival.

Disclosure: The study authors’ disclosure information may be found at jamanetwork.com.



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