Abstract 1079P
Background
Based on the first-line CheckMate 067 trial, nivolumab + ipilimumab (NIVO+IPI) has become a standard treatment in stage III/IV melanoma. However, limited data are available from prospective clinical trials on the effectiveness and tolerability of this combination in pretreated patients. Here, real-world data are presented especially for NIVO+IPI and also for NIVO in first and subsequent lines of therapy.
Methods
NICO is a prospective, observational, multicenter study in Germany associated with ADOREG. Enrolled patients with advanced melanoma begin treatment with NIVO or NIVO+IPI according to the marketing authorization. Patients are followed for up to 5 years. The primary objective is overall survival (OS) in patients receiving NIVO+IPI. Secondary objectives include OS in patients treated with NIVO, progression-free survival, safety profiles and adverse event management, treatment patterns, and patient-reported outcomes.
Results
To date (4th interim data cut, December 31, 2020), 762 patients with advanced melanoma have been enrolled; 486 patients received NIVO+IPI (62% in first-line, 34% in subsequent lines) and 276 patients received NIVO (74% first-line, 24% subsequent lines). Among pretreated patients, in both treatment arms approximately two-thirds had received 1 and around one-quarter had received 2 prior systemic therapies. In these pretreated patients, palliative radiotherapies were used 2–4 times more frequently at baseline compared with therapy-naïve patients (NIVO+IPI, 16.9% vs 3.7%; NIVO, 10.6% vs 4.4%). Objective response rates for NIVO+IPI and NIVO were similar in first (49% vs 50%) and subsequent (35% vs 36%) therapy lines. The corresponding median OS was superior for therapy-naïve patients (NIVO+IPI, 34.2 vs 11.2 months; NIVO, 31.1 vs 17.7 months). The general safety profiles of both immuno-oncology therapies were confirmed with no distinct treatment line–related differences.
Conclusions
Overall, both therapies, NIVO and NIVO+IPI, in first and subsequent therapy lines exhibit effective and safe treatment options for patients with advanced melanoma in routine care in Germany.
Clinical trial identification
NCT02990611.
Editorial acknowledgement
Legal entity responsible for the study
Bristol-Myers Squibb GmbH & Co. KGaA, Munich, Germany.
Funding
Bristol Myers Squibb.
Disclosure
R. Gutzmer: Non-Financial Interests, Personal, Other, Honoraria for lectures, advice, meeting support: BMS; Financial Interests, Personal, Other, Honoraria for lectures and advice, meeting support: BMS; Non-Financial Interests, Personal, Other, Honoraria for lectures and advice, meeting support: Roche Pharma; Financial Interests, Personal, Other, Honoraria for lectures and advice, meeting support: Roche Pharma; Non-Financial Interests, Personal, Other, Honoraria for lectures and advice, meeting support: Merck Serono; Financial Interests, Personal, Other, Honoraria for lectures and advice, meeting support: Merck Serono; Non-Financial Interests, Personal, Other, Honoraria for lectures and advice: Amgen; Financial Interests, Personal, Other, Honoraria for lectures and advice: Amgen; Financial Interests, Personal, Funding, Grants: Amgen; Non-Financial Interests, Personal, Other, Honoraria for lectures and advice, meeting support: Pierre Fabre; Financial Interests, Personal, Other, Honoraria for lectures and advice, meeting support: Pierre Fabre; Non-Financial Interests, Personal, Other, Honoraria for lectures and advice: Sanofi Regeneron; Financial Interests, Personal, Other, Honoraria for lectures and advice: Sanofi Regeneron; Financial Interests, Personal, Other, Honoraria for lectures and advice: MSD; Non-Financial Interests, Personal, Other, Honoraria for lectures and advice: Novartis; Financial Interests, Personal, Other, Honoraria for lectures and advice: Novartis; Financial Interests, Personal, Funding, Grants: Novartis; Financial Interests, Personal, Other, Honoraria for lectures and advice: Almirall Hermal; Financial Interests, Personal, Other, Honoraria for lectures and advice: Pfizer; Financial Interests, Personal, Funding, Grants: Pfizer; Financial Interests, Personal, Other, Personal Fees: Bayer; Financial Interests, Personal, Other, Personal Fees: Immunocore; Financial Interests, Personal, Other, Honoraria for lectures and advice: SUN Pharma; Financial Interests, Personal, Other, Honoraria for advice: 4SC; Financial Interests, Personal, Funding, Grants: Johnson&Johnson; Non-Financial Interests, Personal, Other, Honoraria for lectures and advice: Almirall Hermal. T. Eigentler: Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Advisory Role: Leo Pharma; Financial Interests, Personal, Advisory Role: Pierre Fabre. P. Mohr: Financial Interests, Personal, Speaker’s Bureau: Pierre Fabre; Financial Interests, Personal, Speaker’s Bureau: GSK; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Speaker’s Bureau: Merck Germany; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: BMS; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Speaker’s Bureau: Sanofi; Non-Financial Interests, Personal, Other, Board Membership: Pierre Fabre; Non-Financial Interests, Personal, Other, Board Membership: GSK; Non-Financial Interests, Personal, Other, Board Membership: MSD; Non-Financial Interests, Personal, Other, Board Membership: Merck Germany; Non-Financial Interests, Personal, Other, Board Membership: Roche; Non-Financial Interests, Personal, Other, Board Membership: BMS; Non-Financial Interests, Personal, Other, Board Membership: Novartis; Financial Interests, Personal, Other, Board Membership: Sanofi. M. Weichenthal: Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Institutional, Research Grant: Millennium; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Sun Pharma; Financial Interests, Personal, Speaker’s Bureau: Medac; Financial Interests, Personal, Other, Travel: Novartis; Financial Interests, Personal, Other, Travel: Pierre Fabre; Financial Interests, Personal, Other, Travel: MSD; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Novartis. P. Dücker: Financial Interests, Personal, Invited Speaker: AbbVie; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Personal, Other, Study Physician: Merck; Financial Interests, Personal, Other, Lecturer: Sanofi Aventis; Financial Interests, Personal, Other, Lecturer: MSD. C. Gebhardt: Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Pierre-Fabre; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Sanofi-Aventis; Financial Interests, Personal, Advisory Role: SUN Pharma; Financial Interests, Personal, Speaker’s Bureau: BMS; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Speaker’s Bureau: Pierre-Fabre; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: Sanof-Aventis. D. Göppner: Financial Interests, Personal, Other, Travel Support: Pierre Fabre Pharma GmbH; Financial Interests, Personal, Other, Travel Support: Roche Pharma GmbH; Financial Interests, Personal, Other, Travel Support: Bristol-Myers Squibb GmbH & Co. KGaA; Financial Interests, Personal, Other, Travel Support: Novartis Pharma GmbH; Financial Interests, Personal, Other, Travel Support: Sanofi-Aventis GmbH. I. Grimmelmann: Financial Interests, Personal, Other, Honoraria: Novartis; Financial Interests, Personal, Other, Honoraria: Roche; Financial Interests, Personal, Other, Honoraria: BMS; Financial Interests, Personal, Other, Honoraria: MSD; Financial Interests, Personal, Other, Honoraria: Sanofi; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Other, Travel: Novartis; Financial Interests, Personal, Other, Travel: Roche; Financial Interests, Personal, Other, Travel: BMS; Financial Interests, Personal, Other, Travel: MSD; Financial Interests, Personal, Funding, Research Funding: Pfizer; Financial Interests, Personal, Funding, Research Funding: Novartis. S. Haferkamp: Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role, Consulting: MSD; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role, Consulting: Roche; Financial Interests, Personal, Advisory Role, Consulting: Pierre Fabre. K.C. Kähler: Financial Interests, Personal, Other, Honoraria: Amgen; Financial Interests, Personal, Other, Honoraria: Roche; Financial Interests, Personal, Other, Honoraria: BMS; Financial Interests, Personal, Other, Honoraria: MSD; Financial Interests, Personal, Other, Honoraria: Novartis; Financial Interests, Personal, Other, Honoraria: Pierre Fabre; Financial Interests, Personal, Other, Honoraria: Medac. F. Meier: Financial Interests, Personal, Other, Travel and/or speaker's fee, and/or honoraria: Novartis; Financial Interests, Personal, Other, Travel and/or speaker's fee, and/or honoraria: Roche; Financial Interests, Personal, Other, Travel and/or speaker's fee, and/or honoraria: MSD; Financial Interests, Personal, Other, Travel and/or speaker's fee, and/or honoraria: BMS; Financial Interests, Personal, Other, Travel and/or speaker's fee, and/or honoraria: Pierre Fabre; Financial Interests, Personal, Funding, Research: Novartis; Financial Interests, Personal, Funding, Research: Roche. C. Pföhler: Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Other, Honoraria: Novartis; Financial Interests, Personal, Other, Clinical Studies: Novartis; Financial Interests, Personal, Other, Honoraria: BMS; Financial Interests, Personal, Other, Clinical Studies: BMS; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Other, Honoraria: Roche; Financial Interests, Personal, Advisory Board: Merck Serono; Financial Interests, Personal, Other, Honoraria: Merck Serono; Financial Interests, Personal, Other, Honoraria: Celgene; Financial Interests, Personal, Other, Honoraria: AbbVie; Financial Interests, Personal, Other, Honoraria: MSD; Financial Interests, Personal, Other, Honoraria: Leo. T. Sickmann: Financial Interests, Personal, Full or part-time Employment: BMS; Financial Interests, Personal, Stocks/Shares: BMS. A. Sindrilaru: Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Other, Speaker Local Conference: MSD; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Roche Pharma; Financial Interests, Personal, Advisory Board: Takeda Pharma; Financial Interests, Personal, Advisory Board: SUN Pharma; Financial Interests, Personal, Other, Speaker Local Conference: Takeda; Financial Interests, Personal, Advisory Board: Sanofi Genzyme; Financial Interests, Personal, Other, Speaker Local Conference: Sanofi Genzyme; Financial Interests, Personal, Other, Speaker Local Conference: Recordati Rare Diseases. P. Terheyden: Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Pierre-Fabre; Financial Interests, Personal, Invited Speaker: CureVac; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Kyowa Kirin; Financial Interests, Personal, Invited Speaker: Biofrontera; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pierre-Fabre; Financial Interests, Personal, Advisory Board: Merck Serono; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Kyowa Kirin; Financial Interests, Personal, Other, Travel Support: BMS; Financial Interests, Personal, Other, Travel Support: Pierre-Fabre. S. Ugurel: Financial Interests, Personal, Other, Personal Fees: BMS; Non-Financial Interests, Personal, Other, Non-Financial Support: BMS; Financial Interests, Personal, Other, Grant: BMS; Financial Interests, Personal, Other, Personal Fees: MSD; Non-Financial Interests, Personal, Other, Non-Financial Support: MSD; Financial Interests, Personal, Other, Personal Fees: Merck Serono; Financial Interests, Personal, Other, Grant: Merck Serono; Financial Interests, Personal, Other, Personal Fees: Novartis; Financial Interests, Personal, Other, Personal Fees: Roche; Non-Financial Interests, Personal, Other, Non-Financial Support: Roche. J. Ulrich: Financial Interests, Personal, Other, Consulting, lectures: BMS; Financial Interests, Personal, Other, Lectures: Novartis; Financial Interests, Personal, Other, Grants: Novartis; Financial Interests, Personal, Other, Lectures: Roche; Financial Interests, Personal, Other, Lectures: Sanofi; Financial Interests, Personal, Other, Travel Expenses: Medac; Financial Interests, Personal, Other, Lectures: Medac; Financial Interests, Personal, Other, Travel Expenses: Sun Pharma; Financial Interests, Personal, Other, Lectures: Sun Pharma; Financial Interests, Personal, Other, Lectures: MSD; Financial Interests, Personal, Other, Lectures: Merck; Financial Interests, Personal, Other, Lectures: BMS. J. Utikal: Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Amgen. C. Weishaupt: Financial Interests, Personal, Other, Honoraria: Kyowa Kirin; Financial Interests, Personal, Other, Study Payments: BMS. D. Schadendorf: Financial Interests, Personal, Other, Consulting: BMS; Financial Interests, Personal, Other, Honoraria: BMS; Financial Interests, Personal, Speaker’s Bureau: BMS; Financial Interests, Personal, Funding, Research Funding: BMS; Financial Interests, Personal, Other, Travel: BMS; Financial Interests, Personal, Other, Consulting: Roche/Genentech; Financial Interests, Personal, Other, Travel: Roche; Financial Interests, Personal, Other, Honoraria: Roche; Financial Interests, Personal, Other, Consulting: Novartis; Financial Interests, Personal, Other, Honoraria: Novartis; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Other, Travel: Novartis; Financial Interests, Personal, Funding, Research Funding: Novartis; Financial Interests, Personal, Other, Consulting: MSD; Financial Interests, Personal, Other, Honoraria: MSD; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Other, Travel: MSD; Financial Interests, Personal, Funding, Research Funding: MSD; Financial Interests, Personal, Other, Consulting: Merck Serono; Financial Interests, Personal, Other, Honoraria: Merck Serono; Financial Interests, Personal, Speaker’s Bureau: Merck Serono; Financial Interests, Personal, Other, Travel: Merck Serono; Financial Interests, Personal, Funding, Research Funding: Merck Serono; Financial Interests, Personal, Other, Consulting: Amgen; Financial Interests, Personal, Other, Honoraria: Amgen; Financial Interests, Personal, Speaker’s Bureau: Amgen; Financial Interests, Personal, Other, Travel: Amgen; Financial Interests, Personal, Funding, Research Funding: Amgen; Financial Interests, Personal, Other, Consulting: Incyte; Financial Interests, Personal, Speaker’s Bureau: Incyte; Financial Interests, Personal, Other, Honoraria: Incyte; Financial Interests, Personal, Other, Consulting: Pierre Fabre; Financial Interests, Personal, Speaker’s Bureau: Pierre Fabre; Financial Interests, Personal, Other, Honoraria: Pierre Fabre; Financial Interests, Personal, Other, Consulting: Sanofi/Regeneron; Financial Interests, Personal, Speaker’s Bureau: Sanofi/Regeneron; Financial Interests, Personal, Other, Honoraria: Sanofi/Regeneron; Financial Interests, Personal, Other, Consulting: 4SC; Financial Interests, Personal, Other, Honoraria: 4SC; Financial Interests, Personal, Other, Consulting: Array BioPharma; Financial Interests, Personal, Other, Honoraria: Array BioPharma; Financial Interests, Personal, Other, Consulting: Pfizer; Financial Interests, Personal, Other, Honoraria: Pfizer; Financial Interests, Personal, Other, Consulting: Philogen; Financial Interests, Personal, Other, Honoraria: Philogen; Financial Interests, Personal, Other, Consulting: Regeneron; Financial Interests, Personal, Other, Honoraria: Regneron; Financial Interests, Personal, Other, Consulting: Sun Pharma; Financial Interests, Personal, Other, Honoraria: Sun Pharma; Financial Interests, Personal, Other, Consulting: Nektar; Financial Interests, Personal, Other, Honoraria: Nektar; Financial Interests, Personal, Other, Consulting: Immunocore; Financial Interests, Personal, Other, Honoraria: Immunocore; Financial Interests, Personal, Other, Consulting: Sandoz; Financial Interests, Personal, Other, Honoraria: Sandoz; Financial Interests, Personal, Other, Consulting: Neracare; Financial Interests, Personal, Other, Honoraria: Neracare; Financial Interests, Personal, Other, Consulting: InFlarX; Financial Interests, Personal, Other, Honoraria: InFlarX; Financial Interests, Personal, Other, Consulting: OncoSec; Financial Interests, Personal, Other, Honoraria: OncoSec.