Nivolumab, Ipilimumab Combination Therapy Improves Overall Survival for Patients With Melanoma, Brain Metastases


Approximately 40% of patients with stage IV melanoma have brain metastases at diagnosis.

Combination therapy using nivolumab and ipilimumab demonstrated benefits to overall survival (OS) for patients with melanoma that has spread to the brain, according to phase 2 study results published in The Lancet Oncology. OS for asymptomatic patients receiving the combination therapy was 71.9%, whereas patients with symptomatic brain metastases or on corticosteroid therapy had an OS rate of 36.6%.

“Inducing an intracranial response with combination immunotherapy has a direct and lasting impact on survival for patients whose melanoma has spread to the brain,” said Hussein Tawbi, MD, PhD, professor of Melanoma Medical Oncology and co-director of the Brain Metastasis Clinic at MD Anderson, in a press release. “We’ve shown that this treatment offers a chance of long-term survival to patients with a historically dire prognosis.”

According to the investigators, approximately 40% of patients with stage IV melanoma have brain metastases at diagnosis, whereas 75% develop brain metastases at some point. Prior to the introduction of this therapy, the 1-year survival rate for patients with melanoma brain metastases was approximately 20%.

The investigator-assessed clinical benefit rate was 57.4% and the objective response rate (ORR) was 53.5% in asymptomatic patients, similar to response rates in metastatic melanoma patients without brain metastases. The clinical benefit and ORR were both 16.7% in symptomatic patients. Intracranial progression-free survival at 3 years was 54.1% in asymptomatic patients and 18.9% in symptomatic patients.

“These results confirm that combination immunotherapy is effective and should be considered as a front-line option for asymptomatic patients with melanoma brain metastases,” Tawbi said in the release. “The study also highlights the ongoing need for effective options for symptomatic patients, and the opportunity to help this population further by working on ways to eliminate the need for steroids.”

No new safety signals were identified, and toxicity was similar to previous trials in advanced melanoma patients without brain metastases. The most common serious treatment-related adverse events were colitis, diarrhea, pituitary inflammation, and elevated liver enzymes.

“Combination immunotherapy remains a highly toxic treatment regimen, so one of our next areas of focus is developing treatments that are safer for patients and still just as effective,” Tawbi said. “Historically, many patients with brain metastases have been excluded from clinical trials. Now, we’re showing that it’s possible to run trials specifically dedicated to this population.”


Combination immunotherapy improves survival for patients with asymptomatic melanoma brain metastases [news release]. EurekAlert; November 10, 2021. Accessed November 11, 2021.

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