David F. McDermott, MD, director of the Biologic Therapy Program at Beth Israel Deaconess Medical Center, discusses the findings of the phase III CheckMate-025 trial of nivolumab (Opdivo) versus everolimus (Afinitor) in renal cell carcinoma (RCC).

The results of the trial demonstrated that nivolumab was significantly superior to everolimus in patients who had failed prior antiangiogenic therapy, with improvements in overall survival (OS), quality of life, and safety.

Knowledge of the safety profile of an immunotherapy such as nivolumab is important, especially when the drug is administered over a long period of time, says McDermott. Most of the toxicities associated with nivolumab occurred in the first 6 months, and adverse events seemed to decrease after that point.

In fact, in the phase II trial, after 30 months on nivolumab, no adverse events were observed in patients on the study, according to McDermott. These findings are very encouraging for patients who may require chronic therapy.

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Dr. McDermott on Major Findings of Efficacy and Safety of Nivolumab in RCC

David F. McDermott, MD, director of the Biologic Therapy Program at Beth Israel Deaconess Medical Center, discuses nivolumab (Opdivo) in renal cell carcinoma (RCC).

In the phase III CheckMate-025 trial, nivolumab was significantly superior to everolimus (Afinitor) in patients who had failed prior antiangiogenic therapy, with improvements in overall survival (OS), quality of life, and safety.  

The phase trial is about the cleanest study that we have ever had in kidney cancer, said McDermott. There were clear improvements in overall survival (OS), quality of life, and safety. There were meaningful improvements and not just statistically significant improvements, he added.    

However, there are still challenges with the drug, said McDermott. Selection needs to be improved, as over one-third of patients don’t seem to benefit much from nivolumab.  

Combinations should also be considered, he said.   

Dr. David F. McDermott on Nivolumab in RCC

David F. McDermott, MD, associate professor of Medicine, Harvard Medical School, staff physician, director, Biologic Therapy and Cutaneous Oncology Programs, Hematology/Oncology, Beth Israel Deaconess Medical Center, discusses long-term follow-up results of treatment with nivolumab (Opdivo) for patients with renal cell carcinoma (RCC).

Long-term outcomes from phase I and II studies of nivolumab demonstrate that the median overall survival was 22 months. However, with 48 months of follow-up, it was found that approximately one-third of patients were alive at 4 years and one-third were alive at 5 years. Compared with data from 5 to 10 years ago, these results are very encouraging, McDermott explains.

Longer follow-up will need to be conducted of the phase III study. However, McDermott says that an interesting point about these data is that it can impact a broader group of patients with RCC.

Dr. McDermott on Long-Term Benefit With Nivolumab in RCC

David F. McDermott, MD, associate professor, Department of Medicine, Harvard Medical School/Dana-Farber Cancer Institute, discusses the potential of agents that target PD-1 or PD-L1 as treatments for patients with kidney cancer.

McDermott says data so far for treatments that target PD-1 or PD-L1 in patients with kidney cancer has been remarkable, specifically since many tumors express PD-L1 on the cell surface, as a way of avoiding being attacked by the immune system.

This ability of the tumor to supress the immune system can now be blocked with the administration of monoclonal antibodies, states McDermott. These agents bind to the ligand (PD-L1) or its receptor on the T cell (PD-1) resulting in a recovery of T cell function that causes antitumor activity.

David F. McDermott, MD, associate professor, Department of Medicine, Harvard Medical School/Dana-Farber Cancer Institute, discusses the potential of targeting PD-1 or PD-L1 in patients with kidney cancer

David F. McDermott, MD

Articles

Dr. McDermott on Major Findings of Efficacy and Safety of Nivolumab in RCC

Dr. David F. McDermott on Nivolumab in RCC

Dr. McDermott on Long-Term Benefit With Nivolumab in RCC

Dr. McDermott on Targeting PD-1/PD-L1 in Kidney Cancer