Abstract 1104P
Background
Although melanoma brain metastases (MBM) have a relative incidence of 10%–40% in stage IV disease and often contribute directly to the cause of death, these patients are mostly excluded from prospective clinical studies due to their poor prognoses. Comparatively little is thus known about the effectiveness and tolerability of NIVO and NIVO+IPI in this vulnerable patient population, and real-world evidence for NIVO+IPI, a standard treatment option for MBM, is lacking for first and subsequent lines of therapy.
Methods
NICO is a prospective, observational, multicenter study in Germany associated with ADOREG, assigned to enroll up to 750 patients with advanced melanoma who begin NIVO or NIVO+IPI treatment according to the marketing authorization. Patients will be followed for up to 5 years with assessments performed according to routine clinical practice. The primary objective is overall survival in patients receiving NIVO+IPI. Secondary objectives include overall survival in patients treated with NIVO, progression-free survival, safety profiles, adverse event management, treatment patterns, and patient-reported outcomes.
Results
Of all 623 patients (data cut 30/09/2019) enrolled with advanced melanoma, 64% received NIVO+IPI and 36% NIVO, compared with 74% and 27%, respectively, of patients with MBM (n = 175). NIVO+IPI was preferred over NIVO for patients with more advanced intracranial disease at baseline (MBM, 33.9 vs 21.1%) and who were younger (≤65 years, 62.1 vs 33.9%). For both treatment options, similar fractions of MBM patients were treated in the first (∼60%) and subsequent therapy lines (∼40%), with better responses for therapy-naïve patients (best overall response rate for NIVO+IPI, 31.0% vs 23.7%; NIVO, 26.9% vs 24%) by trend. The general safety profiles of both immuno-oncology therapies were confirmed. No new safety signals were observed.
Conclusions
We present first real-world data from the second interim analysis of the NICO study in MBM patients treated with NIVO or NIVO+IPI in the first and subsequent treatment lines in routine care in Germany. Overall, both therapies provide effective and safe treatment options.
Clinical trial identification
NCT02990611.
Editorial acknowledgement
Legal entity responsible for the study
Bristol-Myers Squibb Company.
Funding
Bristol-Myers Squibb GmbH & Co. KGaA.
Disclosure
R. Gutzmer: Honoraria (self): BMS; Honoraria (self): Roche; Honoraria (self): Merck Serono; Honoraria (self), Research grant/Funding (institution): Amgen; Honoraria (self): Pierre Fabre; Honoraria (self): Sanofi Regeneron; Honoraria (self): Merck Sharp-Dohme; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self): Almirall Hermal; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self): SUN Pharma; Honoraria (self): 4SC; Research grant/Funding (institution): Johnson&Johnson. T. Eigentler: Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Sanofi; Advisory/Consultancy: Leo Pharma; Advisory/Consultancy: Pierre Fabre. P. Mohr: Speaker Bureau/Expert testimony, Officer/Board of Directors, Board membership: Pierre Fabre; Speaker Bureau/Expert testimony, Officer/Board of Directors, Board membership: GSK; Speaker Bureau/Expert testimony, Officer/Board of Directors, Board membership: MSD; Speaker Bureau/Expert testimony, Officer/Board of Directors, Board membership: Merck Germany; Speaker Bureau/Expert testimony, Officer/Board of Directors, Board membership: Roche; Speaker Bureau/Expert testimony, Officer/Board of Directors, Board membership: BMS; Speaker Bureau/Expert testimony, Officer/Board of Directors, Board membership: Novartis; Speaker Bureau/Expert testimony, Officer/Board of Directors, Board membership: Sanofi. M. Weichenthal: Advisory/Consultancy, Research grant/Funding (institution): BMS; Advisory/Consultancy, Research grant/Funding (institution): MSD; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Millennium; Advisory/Consultancy: Sun; Advisory/Consultancy: Pierre-Fabre; Advisory/Consultancy: Takeda; Advisory/Consultancy: Kyowa-Kirin. P. Dücker: Advisory/Consultancy, Lecturer: Roche; Research grant/Funding (self), Study physician, lecturer: Novartis; Advisory/Consultancy, Research grant/Funding (self), Study physician, lecturer: BMS. C. Gebhardt: Advisory/Consultancy, Speaker Bureau/Expert testimony: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pierre Fabre; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Sanofi-Aventis; Advisory/Consultancy: SUN Pharma. D. Göppner: Travel/Accommodation/Expenses: Pierre Fabre Pharm GmbH; Travel/Accommodation/Expenses: Roche Pharma GmbH; Travel/Accommodation/Expenses: BMS GmbH&Co. KGaA; Travel/Accommodation/Expenses: Novartis Pharma GmbH; Travel/Accommodation/Expenses: Sanofi-Aventis GmbH. S. Haferkamp: Advisory/Consultancy: Novartis; Advisory/Consultancy: Roche; Advisory/Consultancy: MSD; Advisory/Consultancy: BMS; Advisory/Consultancy: Pierre Fabre. K. Kähler: Honoraria (self): Amgen; Honoraria (self): Roche; Honoraria (self): BMS; Honoraria (self): Merck Sharp & Dohme; Honoraria (self): Novartis; Honoraria (self): Pierre Fabre; Honoraria (self): Medac. C. Pföhler: Honoraria (self), Advisory/Consultancy, Clinical studies: Novartis; Honoraria (self), Clinical studies: BMS; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Merck Serono; Honoraria (self): Celgene; Honoraria (self): AbbVie; Honoraria (self): LEO; Honoraria (self): MSD. I. Satzger: Honoraria (self): BMS; Honoraria (self): MSD; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self): Sanofi; Honoraria (self): Roche. T. Sickmann: Shareholder/Stockholder/Stock options, Full/Part-time employment: BMS. A. Sindrilaru: Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy, speaker local conference: MSD; Advisory/Consultancy: Novartis; Advisory/Consultancy: Roche Pharma; Honoraria (self), Advisory/Consultancy: Takeda Pharma; Advisory/Consultancy: SUN Pharma; Honoraria (self), Advisory/Consultancy, speaker local conference: Sanofi; Honoraria (self), speaker local conference: Recordati Rare Diseases. P. Terheyden: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Travel/Accommodation/Expenses: Pierre-Fabre; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Roche; Advisory/Consultancy: Novartis; Honoraria (self): Biofrontera. S. Ugurel: Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Merck Serono; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Roche. J. Ulrich: Honoraria (self), Advisory/Consultancy, Lectures: BMS; Honoraria (self), Lectures: Novartis; Honoraria (self), Lectures: Roche; Honoraria (self), Lectures: Sanofi; Honoraria (self), Travel/Accommodation/Expenses, Lectures: Medac; Honoraria (self), Travel/Accommodation/Expenses, Lectures: Sun Pharma; Honoraria (self), Lectures: MSD; Honoraria (self), Lectures: Merck. J. Utikal: Advisory/Consultancy: BMS; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: MSD; Advisory/Consultancy: Roche; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Amgen. C. Weishaupt: Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self): Pierre Fabre; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self): Amgen; Honoraria (self), Advisory/Consultancy: Sanofi. D. Schadendorf: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche/Genentech; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Merck Serono; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Amgen; Honoraria (self), Advisory/Consultancy: Immunocore; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Incyte; Honoraria (self), Advisory/Consultancy: 4SC; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Pierre Fabre; Advisory/Consultancy: Sanofi/Regeneron; Travel/Accommodation/Expenses: Merck; Honoraria (self): Agenus; Honoraria (self): Array BioPharma; Honoraria (self): Pfizer; Honoraria (self): Philogen; Honoraria (self): Regeneron; Advisory/Consultancy: Nektar; Advisory/Consultancy: Sandoz. All other authors have declared no conflicts of interest.