Efficacy and safety of the combination of nivolumab (NIVO) plus ipilimumab (IPI) in patients with symptomatic melanoma brain metastases (MBM; CheckMate 204)


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Hussein Tawbi1,Peter Forsyth2,F. Stephen Hodi3,Christopher Lao4,Stergios Moschos5,Omid Hamid6,Michael B. Atkins7,Karl Lewis8,Reena P. Thomas9,John A. Glaspy10,Sekwon Jang11,Alain Algazi12,Nikhil I. Khushalani2,Michael A. Postow13,Anna C. Pavlick14,Marc Ernstoff15,David A. Reardon3,Agnes Balogh16,Jasmine Rizzo16,Kim Margolin17
1University of Texas MD Anderson Cancer Center, Houston, US,2Moffitt Cancer Center and Research Institute, Tampa, US,3Dana-Farber Cancer Institute, Boston, US,4University of Michigan, Ann Arbor, US,5University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, US,6The Angeles Clinic and Research Institute, Los Angeles, US,7Georgetown Lombardi Comprehensive Cancer Center, Washington, US,8University of Colorado Comprehensive Cancer Center, Aurora, US,9Stanford University Hospital, Stanford, US,10Jonsson Comprehensive Cancer Center University of California, Los Angeles, US,11Inova Schar Cancer Institute, Falls Church, US, Virginia Commonwealth University, Richmond, US,12University of California–San Francisco, San Francisco, US,13Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, US,14New York University Langone Medical Center, New York, US,15Roswell Park Cancer Institute, Buffalo, US,16Bristol-Myers Squibb, New York, US,17City of Hope, Duarte, US

Abstract

Background

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.

Method

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.

Results

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).

Conclusion

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.