Nivolumab plus ipilimumab in melanoma patients with asymptomatic brain metastases: 7-year outcomes and quality of life from the multicenter phase III NIBIT-M2 trial

• Published in: European journal of cancer (1990) 2024-03, Vol.199, p.113531-113531, Article 113531
• Main Authors: Di Giacomo, Anna Maria, Chiarion-Sileni, Vanna, Del Vecchio, Michele, Ferrucci, Pier Francesco, Guida, Michele, Quaglino, Pietro, Guidoboni, Massimo, Marchetti, Paolo, Simonetti, Elena, Santangelo, Federica, Amato, Giovanni, Covre, Alessia, Camerini, Roberto, Valente, Monica, Mandalà, Mario, Giannarelli, Diana, Calabrò, Luana, Maio, Michele
• Format: Article
• Language: English
• Subjects: Antineoplastic Combined Chemotherapy Protocols - adverse effects; Brain metastases; Brain Neoplasms - secondary; Health-Related Quality of Life (HRQoL); Humans; Ipilimumab; Ipilimumab - adverse effects; Long-term survival; Melanoma; Melanoma - pathology; Nitrosourea Compounds; Nivolumab; Nivolumab - adverse effects; Organophosphorus Compounds; Quality of Life
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/j.ejca.2024.113531

The primary analysis of the phase III NIBIT-M2 study showed a 41% 4-year overall survival (OS) of melanoma patients with asymptomatic brain metastases treated with ipilimumab plus nivolumab. Here, we report the 7-year efficacy outcomes and the Health-Related Quality of Life (HRQoL) analyses of the NIBIT-M2 study. As of May 1, 2023, at a median follow-up of 67 months (mo), the median OS was 8.5 (95% CI: 6.6–10.3), 8.2 (95% CI: 2.1–14.3) and 29.2 (95% CI: 0–69.9) mo for the fotemustine (F) Arm A, ipilimumab plus fotemustine Arm B, and ipilimumab plus nivolumab Arm C, respectively. The 7-year OS rate was 10.0% (95% CI: 0–22.5) in Arm A, 10.3% (95% CI: 0–22.6) in Arm B, and 42.8% (95% CI: 23.4–62.2) in Arm C. HRQoL was preserved in all treatment arms. Most functional scales evaluated from baseline to W12 were preserved, with a lower mean score decrease for EORTC Quality of Life Questionnaire (QLQ)-C30 and an increase for EORTC QLQ-Brain neoplasm (BN20) in patients receiving ipilimumab plus nivolumab. With the longest follow-up available to date in melanoma patients with asymptomatic brain metastases, the NIBIT-M2 study continues to show persistent therapeutic efficacy of I ipilimumab plus nivolumab while preserving HRQoL. •Ipilimumab plus nivolumab is effective in asymptomatic melanoma brain metastases.•The NIBIT-M2 study showed persistent efficacy of ipilimumab plus nivolumab at 7-year.•Ipilimumab plus nivolumab may prevent melanoma recurrence in the brain.•Ipilimumab plus nivolumab preserved HRQoL in treated patients.•A meaningful percentage of patients may be cured from therapy.