Clin Cancer Res: Long-term follow-up results of the Phase 3 trial of Ipilimumab + Nivolumab in the treatment of brain metastatic melanoma

Phase 2 trials showed that the activity of ipilimumab combined with fotemustine and ipilimumab combined with nivolumab in the treatment of melanoma brain metastases is encouraging

The NIBIT-M2 trial is the first phase 3 trial comparing these regimens in combination with fortimostine in melanoma patients who have developed brain metastases Phase 3 trial in melanoma patients who have developed brain metastases

This article reports the main analysis results of the NIBIT-M2 trial after 4 years of follow-up

The trial enrolled patients with BRAF wild-type or mutant melanoma who were 18 years of age or older, and required the subjects to have asymptomatic brain metastases, but had not been treated for brain metastases

The overall survival of the three groups of patients

The overall survival of the three groups of patients

From January 2013 to September 2018, 27, 26, and 27 received formustine, ipilimumab + fortimustine, or ipilimumab + nivolumab, respectively Treatment

The median OS of the formostine group, the ipilimumab+formimustine group, and the ipilimumab+nivolumab group were 8.

Survival without intracranial progression of the three groups of patients

Survival without intracranial progression of the three groups of patients

The 4-year survival rate of the ipilimumab+nivolumab group was significantly higher than that of the formostine group (41.

The 4-year survival rate of the ipilimumab+nivolumab group was significantly higher than that of the fortimostine group.

Adverse event rate

Adverse event rate

The incidence of grade 3-4 treatment-related adverse events in the formostine group, ipilimumab+formimustine group, and ipilimumab+nivolumab group was 48% (11 cases), respectively , 69% (18 cases) and 30% (8 cases), there were no treatment-related deaths

In conclusion, compared with formolimustine, ipilimumab combined with nivolumab can significantly improve the overall survival and long-term survival of melanoma patients with asymptomatic brain metastases

Compared with formustine, ipilimumab combined with nivolumab can significantly improve the overall survival and long-term survival rate of melanoma patients with asymptomatic brain metastases.

Original source:

Anna Maria Di Giacomo, et al.

Primary Analysis and 4-Year Follow- Up of the Phase III NIBIT-M2 Trial in Melanoma Patients With Brain Metastases

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