108P - Real-world (RW) effectiveness and safety of adjuvant nivolumab (NIVO) in patients (pts) with melanoma in Belgium and Luxembourg: PRESERV MEL

Background

Adjuvant NIVO is approved for pts with melanoma with lymph node involvement/metastatic disease who have undergone complete resection. PRESERV MEL is an observational study aiming to describe effectiveness, safety, and quality of life in pts treated with adjuvant NIVO in the RW. Updated results are shown.

Methods

Pts were enrolled prospectively/retrospectively over a 2-y period and are being followed for 5 y. Index date was first NIVO administration. Pts received NIVO for ≤ 12 mo per label. Recurrence-free survival (RFS), distant metastasis-free survival (DMFS; including baseline stage IV pts), time to discontinuation (TTD), subsequent treatment (tx), and adverse events (AEs)/tx-related AEs (TRAEs) were assessed.

Results

In total, 152 pts (125 prospective; 27 retrospective) were enrolled (Jan 2019–Dec 2020) at 15 sites in Belgium and Luxembourg. Median follow-up was 25 mo. Median TTD was 11.1 mo. All pts ended tx due to tx completion (56%), AE (23%), recurrence (15%), pt decision unrelated to AE (1%), or other reason (5%). Median RFS was 47.2 mo, 2-y RFS rate was 62%, median DMFS was not reached, and 2-y DMFS rate was 72% (Table). Sites of first recurrence in pts with distant recurrence (n = 41; 27%) were soft tissue (39%), lungs (34%), multiple organs (37%), skin (27%), liver (22%), lymph nodes (22%), bone (15%), brain (7%), intestines (5%), other visceral organs (17%), and other (2%). Subsequent tx was used in 51 pts (34%), including surgery (9%), radiotherapy (8%), and systemic tx (32% [adjuvant tx, 10%; unresectable/metastatic tx, 22%]). Median time from NIVO discontinuation (D/C) to subsequent tx was 12.6 mo. Grade 3/4 TRAEs occurred in 21 pts (14%). Any AEs led to tx D/C in 35 pts (23%). Late-emergent grade 3/4 TRAEs (100 d–2 y after tx) were reported in 3 pts (2%; 2 of 3 pts had prior TRAE occurrence). Table: 108P

NR, not reached.

Conclusions

RW effectiveness and safety of adjuvant NIVO in pts with resected stage III/IV melanoma in PRESERV MEL were consistent with CheckMate 238 results.

Editorial acknowledgement

Medical writing support for the development of this abstract, under the direction of the authors, was provided by Mark Palangio of Ashfield MedComms, an Inizio company, and funded by Bristol Myers Squibb.

Legal entity responsible for the study

Bristol Myers Squibb.

Funding

Bristol Myers Squibb.

Disclosure

B. Neyns: Financial Interests, Institutional, Advisory Board: Novartis, Bristol Myers Squibb, Pierre Fabre, MSD (Merck Sharp & Dohme); Financial Interests, Institutional, Research Grant: Novartis, Pfizer; Non-Financial Interests, Institutional, Product Samples: Bayer. L. McDonald: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks or ownership: Bristol Myers Squibb. H. Van Campenhout: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks or ownership: Bristol Myers Squibb. C. Jacobs: Financial Interests, Institutional, Advisory Board: BMS, Novartis, Pierre Fabre, MSD; Financial Interests, Institutional, Invited Speaker: BMS. A. Rogiers: Financial Interests, Personal, Advisory Board: MSD, BMS. A. Rorive: Financial Interests, Personal, Advisory Board: BMS, Novartis, MSD, Pierre Fabre; Financial Interests, Personal, Invited Speaker: BMS, Novartis, MSD, Pierre Fabre. All other authors have declared no conflicts of interest.