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Melanoma Think Tank

CME

Think Tank on Melanoma: Optimizing Therapy for Patients in an Evolving Treatment Landscape

Physicians: Maximum of 1.00 AMA PRA Category 1 Credit™

Released: August 02, 2023

Expiration: August 01, 2024

Evan J. Lipson
Evan J. Lipson, MD
CME/CE Information

Activity

Progress
1
Course Completed

ABC Study of Nivolumab ± Ipilimumab in Patients With Melanoma Brain Metastases: Intracranial PFS at 5 Years

Brain metastases are not uncommon in melanoma and can be difficult to manage. The open-label phase II ABC study is evaluating the efficacy of nivolumab with or without ipilimumab in patients with melanoma brain metastases.36 Patients with symptomatic brain metastases received nivolumab alone (n = 16), whereas asymptomatic patients were randomized to receive the combination (n = 35) or nivolumab alone (n = 25). 

What is of note from the PFS curve is the improvement in intracranial PFS with the addition of ipilimumab to nivolumab in the asymptomatic cohort, which was 5.4 months vs 2.5 months.

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Checkmate 204 Nivolumab ± Ipilimumab for Melanoma Brain Metastases: PFS in Asymptomatic Patients

The open-label phase II CheckMate 204 trial also evaluated the efficacy of nivolumab with or without ipilimumab in patients with asymptomatic or symptomatic brain metastases.37 In asymptomatic patients (n = 101) at 36 months, the global PFS rate was 45.4% and the intracranial PFS rate was 54.1%. The median intracranial PFS by BICR was 39.3 months.

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Checkmate 204 Nivolumab ± Ipilimumab for Melanoma Brain Metastases: PFS in Symptomatic Patients

Several trials have found that patients who are symptomatic from their brain metastases generally do not do as well as asymptomatic patients.36, 37 Among the 18 patients with symptomatic disease in the Checkmate 204 study who received nivolumab, the global 36-month PFS rate was 23.9% and the intracranial PFS was 18.9%. The median intracranial PFS by BICR was only 1.2 months in this patient population.  

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COMBI-MB: Dabrafenib + Trametinib in Patients With BRAFV600-Mutant Melanoma and CNS Metastases

The phase II COMBI MB trial evaluated dabrafenib plus trametinib in patients with BRAFV600D/E/K/R-mutant melanoma and brain metastases (N = 125).38 Patients had received ≤2 previous systemic therapies for metastatic disease and no previous BRAF or MEK inhibitors. The primary endpoint was investigator-assessed intracranial response in cohort A. 

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COMBI-MB Cohort A: Dabrafenib + Trametinib in BRAFV600E-Mutant Melanoma and CNS Metastases

Seventy-six patients with BRAFV600E melanoma and asymptomatic brain metastases who had no previous therapy were enrolled in cohort A. With a median OS of 10.8 months, results from cohort A showed that dabrafenib and trametinib have antitumor activity in this patient population.38 However, the median intracranial DoR was relatively short at 6.5 months.

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Interactive Decision Tool Patient Case 4

This case profiles a patient with BRAF-mutant melanoma and symptomatic CNS metastases who is receiving steroids. Local therapy to eliminate steroids is being considered.

For this patient, 3 faculty members recommended initiation of BRAF/MEK inhibitor combination therapy upfront. The other 2 faculty recommended ipilimumab plus nivolumab. It is hard to compare, but if you look at the immunotherapy studies we just talked about and the targeted therapy studies, the DoR is better for the immunotherapy.

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