1103P - Real-world efficacy of relatlimab and nivolumab in advanced or resectable melanoma

Background

Fixed-dose combination NIV-RELA improves progression-free survival (PFS) compared to NIV in patients (pts) with therapy-naive advanced melanoma (MEL) (10.1m vs. 4.6m) but has limited activity after prior immunotherapy. The pathologic response rate (pathRR) to neoadjuvant NIV-RELA is 70%. Real-world data on safety & efficacy of NIV-RELA is lacking. We report the largest single center experience of NIV-RELA in advanced MEL & as neoadjuvant therapy in resectable MEL.

Methods

All MEL pts treated with NIV-RELA from FDA approval until 3/2024 were grouped in 3 cohorts (C): 1^st line (C1, n=68) or subsequent line (C2, n=120) advanced MEL & neoadjuvant (C3, n=17). Safety, PFS, overall survival (OS) & pathRR in relation to MEL characteristics were evaluated.

Results

The table shows demographic and efficacy data. In C1, pts with ≥3 vs. upper level of normal (ULN) LDH pts had improved PFS (p=0.04). For C2 pts, ≥3 vs. ULN LDH and ECOG 0 vs. ECOG ≥1 had improved OS (p

Conclusions

Combination Our cohort confirms 1^st-line efficacy of NIV-RELA in advanced MEL but with high rate of steroid-requiring AEs. For subsequent lines, pts with prior anti-PD1 only may derive greater benefit. In resectable MEL, the pathRR appears lower than previously reported.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

Z. Eroglu: Financial Interests, Personal, Advisory Board: Pfizer, Regeneron, SunPharma, Incyte; Non-Financial Interests, Institutional, Research Funding: Pfizer, Novartis, Boehringer Ingelheim-Ingelheim. J. Markowitz: Non-Financial Interests, Personal, Research Funding: Merck, Morphogenesis, Microba. A. Tarhini: Financial Interests, Personal, Advisory Role: Bristol Myers Squibb, Merck, Genetech/Roche, Sanofi/Regeneron, Novartis, Partner Therapeutics; Non-Financial Interests, Institutional, Research Funding: Bristol Myers Squibb, Merck, Genetech/Roche, Sanofit/Regeneron; Financial Interests, Personal, Advisory Board: Eisai, Bayer, Instil Bio, ConcertAI, BioNTech; Financial Interests, Institutional, Funding: OncoSec (Inst), Sanofi/Regeneron (Inst), Clinigen Group (Inst), InflaRx (Inst), Acrotech Biopharma (Inst), Pfizer (Inst), Agenus (Inst), Scholar Rock (Inst). J. Messina: Non-Financial Interests, Leadership Role, Co-chair two committees: Fellowship Director's Committee and Program Committee: American Society of Dermatopathology. K.Y. Tsai: Financial Interests, Personal, Advisory Board: NFlection Therapeutics; Financial Interests, Personal, Other, Consultant: Verrica Pharmaceuticals; Financial Interests, Institutional, Full or part-time Employment: Moffitt Cancer Center; Financial Interests, Personal, Stocks/Shares: 3CC, NFlection Therapeutics; Financial Interests, Institutional, Research Grant: Incyte; Non-Financial Interests, Member: ASCO. J.S. Zager: Financial Interests, Personal, Invited Speaker: Merit Medical; Financial Interests, Personal, Advisory Board: Delcath Systems, Merck, Philogen; Financial Interests, Institutional, Research Grant: Delcath Systems; Financial Interests, Institutional, Local PI: Provectus; Financial Interests, Institutional, Coordinating PI: Philogen. A. Sarnaik: Financial Interests, Institutional, Other, Sponsored research and Institutional patent licensed: Iovance Biotherapeutics; Financial Interests, Personal, Other, Consultant: Gerson Lehrman Group; Financial Interests, Personal, Other, consultant: Guidepoint; Financial Interests, Personal, Invited Speaker: international workshop CAR-T, Society for the Immunotherapy of Cancer, Blueprint Oncology Concepts, Second City Science, MJH Holdings; Financial Interests, Institutional, Other, Sponsored Research: Turnstone Biologics Inc; Financial Interests, Personal, Other, Sponsored research and personal patent: Provectus Biopharmaceuticals; Financial Interests, Institutional, Advisory Board, My institution has licensed intellectual property to Iovance Biotherapeutics: Iovance Biotherapeutics; Financial Interests, Personal, Other, I am a co-inventor on a patent application with Provectus Biopharmaceuticals that could provide an income in the future: Provectus; Financial Interests, Personal and Institutional, Trial Chair: Iovance Biotherapeutics; Financial Interests, Institutional, Local PI: Provectus Biotherapeutics, Turnstone Biologics; Non-Financial Interests, Principal Investigator: Turnstone Biologics, Iovance Biotherapeutics. V. Sondak: Financial Interests, Personal, Advisory Board: Merck, Bristol Myers Squibb, Iovance, OncoSec, Regeneron, Ultimovacs; Financial Interests, Personal, Other, Independent Data Safety Monitoring Committee: Alkermes, Novartis; Financial Interests, Personal, Other, Independent medical monitor for clinical trial: Genesis Drug Discovery & Development; Financial Interests, Institutional, Research Grant, Research grant to institution: Turnstone Biologics; Financial Interests, Institutional, Coordinating PI, Per patient funding to institution to support clinical trial: Skyline DX; Financial Interests, Institutional, Local PI, Research grant to institution: Neogene Therapeutics. N.I. Khushalani: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Bristol Myers Squibb, AstraZeneca, Regeneron, Array BioPharma, Immunocore, Merck, Incyte, Jounce Therapeutics, Iovance Biotherapeutics, NCCN/Pfizer, Genzyme, Novartis, Nektar, Castle Biosciences and Instil Bio. All other authors have declared no conflicts of interest.