Nivolumab Demonstrates Durable Long-term Survival in Patients with Advanced Cancers


Study provides the longest available follow-up on the survival of patients with advanced melanoma, renal cell carcinoma, and non-small cell lung cancer treated with nivolumab.

Treatment with nivolumab demonstrated durable survival in previously-treated patients with advanced melanoma, renal cell carcinoma (RCC), or non-small cell lung cancer (NSCLC), according to a new study published in JAMA Oncology.

The study, which included 270 patients, analyzed 5-year survival among those with all 3 cancer types in a phase 1 clinical trial of nivolumab. In the trial, patients received different doses of nivolumab (between 0.1 to 10.0 mg/kg) intravenously in an outpatient clinic every 2 weeks in 8-week cycles for up to 2 years.

Patients in the study were previously treated, with 40.4% having undergone 3 or more prior systemic therapies.

Overall, the data showed estimated 5-year survival rates of 34.2% among patients with melanoma, 27.7% among patients with RCC, and 15.6% among patients with NSCLC.

The study also demonstrated that patients with larger tumor burdens were significantly less likely to survive for 5 years after starting nivolumab treatment. Additionally, patients with low immune cell counts in their blood at the time treatment with nivolumab began were significantly less likely to benefit, as well.

Compared with patients who were experiencing cancer-related symptoms at the start of the trial, those who entered without any symptoms were significantly more likely to survive for 5 years.

“The results of this study suggest that survival benefits reported in the more limited follow-up of recent nivolumab randomized clinical trials may persist for prolonged periods of time in some patients, extending to at least 5 years,” the authors wrote.

Notably, the presence of treatment-related adverse effects (AEs) appeared to be a marker of long-term survival. In the study, patients with AEs associated with nivolumab had a significantly longer overall survival compared with those who did not experience treatment-related AEs. Patients with AEs had a midpoint duration of survival of 19.8 months compared with 5.8 months in those who did not experience any AEs.

“Nivolumab activates immune responses. Although we would like those responses to be directed only at cancer cells, in some cases there is a spillover effect and we encounter immune responses against normal tissues,” lead study author Suzanne Topalian, MD, professor of surgery and associate director of the Bloomberg-Kimmel Institute for Cancer Immunotherapy, said in a press release. “Based on the findings in this study, we can reassure our patients that if they develop these side effects, it may very well put them in a better response and long-term effect category. The real issue is whether we can devise treatments to manage these side effects that will not interfere at all with the anti-tumor immune response.”

Moreover, the authors concluded that understanding the factors associated with long-term survival may help inform treatment approaches for individual patients and strategies for future clinical trial development.


Topalian S, Hodi S, Brahmer JR, et al. Five-year survival and correlates among patients with advanced melanoma, renal cell carcinoma, or non-small cell lung cancer treated with nivolumab. JAMA Oncology. 2019. doi:10.1001/jamaoncol.2019.2187

Favorable Five-Year Survival Reported For Patients With Advanced Cancer Treated With The Immunotherapy Drug Nivolumab [news release]. Johns Hopkins Medicine. Accessed July 29, 2019.

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