Efficacy and safety of the combination of nivolumab (NIVO) plus ipilimumab (IPI) in patients with symptomatic melanoma brain metastases (MBM; CheckMate 204)
Session type: Proffered paper sessions
We previously reported results of the phase 2 CheckMate 204 study (NCT02320058). Here, we provide updated data for patients with asymptomatic MBM and the first report of NIVO+IPI in patients with symptomatic MBM.
Patients with ≥1 measurable, nonirradiated MBM 0.5–3.0 cm were enrolled into cohort A (asymptomatic: patients with no neurologic symptoms and no steroid treatment) or cohort B (symptomatic: patients with neurologic symptoms, regardless of steroid treatment). In both cohorts, patients received NIVO 1 mg/kg + IPI 3 mg/kg Q3W x4, then NIVO 3 mg/kg Q2W until progression/toxicity. The primary endpoint was intracranial clinical benefit rate (CBR; CR + PR + SD ≥6 months). At the clinical cutoff date (May 1, 2018), all treated patients (101 in cohort A; 18 in cohort B) had been followed for ~6 months or longer.
At a median follow-up of 20.6 months in cohort A, the CBR was 58% (95% CI, 48–68). In cohort B, patients received a median of 1 NIVO+IPI dose and 2/18 patients (11%) received all 4 doses; at a median follow-up of 5.2 months, intracranial ORR and CBR was 22% (95% CI, 6–48; 2 CRs, 2 PRs). Treatment-related grade 3/4 AEs occurred in 54% and 56% of patients in cohorts A and B, respectively (nervous system, 7% and 17%), with 1 treatment-related death in cohort A (immune-related myocarditis).
In patients with asymptomatic MBM, updated results showed a high rate of durable intracranial responses, supporting NIVO+IPI as a first-line treatment in this population. Intracranial antitumor activity was observed with NIVO+IPI in patients with symptomatic MBM, but further study is needed.
These results have been previously presented at the American Society for Clinical Oncology (ASCO) Annual Meeting, May 31–June 4, 2019, Chicago, IL, USA, and published in the conference proceedings (Abstract 9501).
© 2019 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2019 ASCO Annual Meeting. All rights reserved.