68P - Real-world outcomes of nivolumab and/or ipilimumab in patients with stage III-IV melanoma, MELIOR study

Background

Immune checkpoint inhibitors and targeted therapies have revolutionized the treatment of melanoma (M) in the last decade. Regardless of BRAF mutation, nivolumab (NIVO) and ipilimumab (IPI), as single agents or in combination have shown significant overall survival (OS) benefits. The aim of this study was to describe the treatment approaches and outcomes of real-life M patients (pt) treated with NIVO and/or IPI in Spain.

Methods

Retrospective chart review of stage III-IV M pt treated (Aug 2018-Nov 2023) with NIVO and/or IPI from the Spanish GEM1801 registry.

Results

Of 1126 registered pt in GEM1801, 502 (44.6%) pt treated with NIVO and/or IPI were analyzed. Most were male (59.0%), had ECOG 0-1 (95.2%), and were BRAF+ (42.8%). At diagnosis, stages were 7.2% I, 14.5% II, 41.6% III, and 36.4% IV. Primary M was diagnosed at a median age of 61.6 years and most were cutaneous M (66.9%). The median time to stage III-IV from a primary diagnosis was 29 months (m). Of 1126 pts, 36.9% received NIVO in the adjuvant setting (ADJ). Treatment with NIVO, IPI, and NIVO+IPI in the first line (1L) was 21.2%, 1.1%, and 12.6% respectively, and 8.4%, 5.2%, and 15.3% in the second line (2L). Relapses (24.1%) and grade 3-4 toxicity (10.6%) were the main reasons for discontinuation in ADJ, while disease progression was for 1L (45.9%) and 2L (51.8%). There were 41 serious adverse reactions in 37 pt (7.4%; 32 pt had a full recovery and 2 pt resulted in death). With a median follow-up of 35.1 m, the median relapse-free survival for ADJ was 22.4 m while the median progression-free survival for 1L was 11.3 m and 3.3 m for 2L. The median OS for ADJ, 1L, and 2L was 66.4 m, 30.8 m and 11.1 m, respectively.

Conclusions

Approximately 50% of M pt included in GEM1801 received NIVO and/or IPI. Single-agent NIVO was more frequently used in the ADJ (36.9%) and 1L (21.2%), while NIVO+IPI was the preferred regimen in 2L. The toxicity profile and survival outcomes observed in the real-life setting were consistent with results from clinical trials.

Editorial acknowledgement

All authors participated in the preparation of this abstract for its presentation. The authors acknowledge Carla Martín Cortázar (Evidenze Health España S.L.U.) for advisory and medical writing support, provided in accordance with Good Publication Practice guidelines (GPP 2022; https://www.ismpp.org/gpp-2022). The authors acknowledge Mayte Mejías and Emilio Pecharroman (MFAR Clinical Research) for advisory and statistical support. The study was funded by Bristol Myers Squibb, Spain.

Legal entity responsible for the study

Bristol Myers Squibb.

Funding

Bristol Myers Squibb.

Disclosure

M.A. Berciano Guerrero: Financial Interests, Personal, Speaker, Consultant, Advisor: Bristol Myers Squibb, MSD Oncology, Eisai, Pierre Fabre, Lilly, Novartis, PharmaMar; Financial Interests, Personal and Institutional, Research Funding: Novartis. E. Muñoz-Couselo: Financial Interests, Personal, Speaker, Consultant, Advisor: BMS, MSD, Novartis, Pierre Fabre, Sanofi; Financial Interests, Personal, Advisory Role: Immunocore, Regeneron, Menarini, Roche; Other, Personal, Leadership Role: Grupo Español de Melanoma, GEM, Sociedad Española de Oncología Médica, SEOM. P. Ayala de Miguel: Financial Interests, Personal, Speaker’s Bureau: Sanofi, MSD, Pierre Fabre. G. Crespo Herrero: Financial Interests, Personal, Speaker, Consultant, Advisor: MSD, BMS, Novartis, Pierre Fabre. L. Ostios Garcia, D. Vilanova Larena: Other, Personal, Full or part-time Employment: Bristol Myers Squibb. All other authors have declared no conflicts of interest.