A matching-adjusted indirect comparison of combination nivolumab plus ipilimumab with BRAF plus MEK inhibitors for the treatment of BRAF-mutant advanced melanoma

被引：15
作者：
Tarhini, A. A. [1 ,2 ]
Toor, K. [3 ]
Chan, K. [3 ]
McDermott, D. F. [4 ,5 ]
Mohr, P. [6 ]
Larkin, J. [7 ]
Hodi, F. S. [8 ]
Lee, C-H [9 ]
Rizzo, J., I [10 ]
Johnson, H. [11 ]
Moshyk, A. [12 ]
Rao, S. [9 ]
Kotapati, S. [13 ]
Atkins, M. B. [14 ]
机构：
[1] H Lee Moffitt Canc Ctr & Res Inst, Dept Cutaneous Oncol, Tampa, FL 33612 USA
[2] H Lee Moffitt Canc Ctr & Res Inst, Dept Immunol, Tampa, FL 33612 USA
[3] Precis HEOR, Evidence Synth & Decis Modeling, Vancouver, BC, Canada
[4] Beth Israel Deaconess Med Ctr, Med Oncol, Boston, MA 02215 USA
[5] Harvard Med Sch, Boston, MA 02115 USA
[6] Elbe Kliniken Buxtehude, Dept Dermatol, Buxtehude, Germany
[7] Royal Marsden Hosp, Med Oncol, London, England
[8] Dana Farber Harvard Canc Ctr, Med Oncol, Boston, MA USA
[9] US Hlth Econ & Outcome Res, Metastat Melanoma, Bristol Myers Squibb, Princeton, NJ USA
[10] Bristol Myers Squibb, Oncol Clin Dev, Princeton, NJ USA
[11] Bristol Myers Squibb, Worldwide Hlth Econ & Outcomes Res, Uxbridge, Middx, England
[12] Bristol Myers Squibb, Worldwide Hlth Econ & Outcomes Res, Princeton, NJ USA
[13] Bristol Myers Squibb, Worldwide Med, Princeton, NJ USA
[14] Georgetown Lombardi Comprehens Canc Ctr, Med Oncol, Washington, DC USA
来源：
ESMO OPEN | 2021年 / 6卷 / 02期
关键词：
advanced melanoma; BRAF/MEK inhibitors; ipilimumab; matching-adjusted indirect comparison; nivolumab; COMPARATIVE EFFICACY; 1ST-LINE TREATMENT; VEMURAFENIB; COBIMETINIB; SURVIVAL;
D O I：
10.1016/j.esmoop.2021.100050
中图分类号：
R73 [肿瘤学];
学科分类号：
100214 ;
摘要：
Background: Approved first-line treatments for patients with BRAF V60-emutant advanced melanoma include nivolumab (a programmed cell death protein 1 inhibitor) plus ipilimumab (a cytotoxic T lymphocyte antigen-4 inhibitor; NIVO+IPI) and the BRAF/MEK inhibitors dabrafenib plus trametinib (DAB+TRAM), encorafenib plus binimetinib (ENCO+BINI), and vemurafenib plus cobimetinib (VEM+COBI). Results from prospective randomized clinical trials (RCTs) comparing these treatments have not yet been reported. This analysis evaluated the relative efficacy and safety of NIVO+IPI versus DAB+TRAM, ENCO+BINI, and VEM+COBI in patients with BRAF-mutant advanced melanoma using a matching-adjusted indirect comparison (MAIC). Patients and methods: A systematic literature review identified RCTs for DAB+TRAM, ENCO+BINI, and VEM+COBI in patients with BRAF-mutant advanced melanoma. Individual patient-level data for NIVO+IPI were derived from the phase III CheckMate 067 trial (BRAF-mutant cohort) and restricted to match the inclusion/exclusion criteria of the comparator trials. Treatment effects for overall survival (OS) and progression-free survival (PFS) were estimated using Cox proportional hazards and time-varying hazard ratio (HR) models. Safety outcomes (grade 3 or 4 treatment-related adverse events) with NIVO+IPI and the comparators were compared. Results: In the Cox proportional hazards analysis, NIVO+IPI showed improved OS compared with DAB+TRAM (HR = 0.53; 95% confidence interval [CI], 0.39-0.73), ENCO+BINI (HR = 0.60; CI, 0.42-0.85), and VEM+COBI (HR = 0.50; CI, 0.36-0.70) for the overall study period. In the time-varying analysis, NIVO+IPI was associated with significant improvements in OS and PFS compared with the BRAF/MEK inhibitors 12 months after treatment initiation. There were no significant differences between NIVO+IPI and BRAF/MEK inhibitor treatment from 0 to 12 months. Safety outcomes favored DAB+TRAM over NIVO+IPI, whereas NIVO+IPI was comparable to VEM+COBI. Conclusion: Results of this MAIC demonstrated durable OS and PFS benefits for patients with BRAF-mutant advanced melanoma treated with NIVO+IPI compared with BRAF/MEK inhibitors, with the greatest benefits noted after 12 months.
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