1074P - Italian nivolumab Expanded Access Program (EAP) in melanoma adjuvant setting: Patients outcomes and safety profile

Background

At a minimum of 4 years’ follow-up, nivolumab demonstrated sustained recurrence-free survival (RFS) benefit versus ipilimumab in resected stage IIIB–C or IV melanoma remaining an efficacious adjuvant treatment with a tolerable safety profile (Ascierto et al. ESMO 2020). The purpose of this analysis is to evaluate if nivolumab use in real world setting confirms the clinical trial data.

Methods

From November 2018 to June 2019 we enrolled 612 patients (pts) with stage III and IV resected melanoma to receive nivolumab as part of an Italian BMS EAP. Patients received intravenous nivolumab 3 mg/kg or 240 mg Q2 weeks or 480 mg Q4 weeks to a maximum of 12 months (62% male and 38% female, median age 60 years (16-86), 420 BRAF WT, 156 BRAF mutated, 36 unknown). Among 612 pts, 77% were stage III (IIIA: 122, IIIB: 132, IIIC: 213, IIID: 4) and 23% were stage IV NED (CM238: IV NED 18%). Most pts had a cutaneous melanoma (89%), 3 uveal and 16 mucosal melanoma. 47 melanomas were of unknown origin. Tumor ulceration was present in 27% of pts.

Results

At the data cut-off of March 2021, 63% of the pts completed 1-year treatment. With a median follow-up of 18 months (IQR 14-21) and a median number of doses of 22 (1-28), the results are the following: Table: 1074P

Among 612 pts, 10% discontinued treatment due to toxicity. Treatment-related grade 3 or 4 adverse events were reported in 11% of pts and 3 (0.5%) treatment-related deaths (rhabdomyolysis, diabetic coma and intestinal hemorrhage) were observed.

Conclusions

The results of this large clinical experience are in line with what reported in the pivotal clinical trial, despite the presence of some more unfavorable prognostic features. Although BRAF mutational status was not available for 36 pts, RFS in BRAF mutated pts was higher than that of CM238. According to these data, nivolumab confirms to be an effective/safe adjuvant treatment for resected stage III-IV melanoma pts, supporting its use in clinical practice.

Clinical trial identification

CA209-67E ECLIPSE number.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

M. Del Vecchio: Other, Personal, Advisory Board, Consultancy, speaker invitation and principal investigator: BMS; Other, Personal, Advisory Board, Consultancy, speaker invitation and principal investigator: Novartis; Other, Personal, Advisory Board, Consultancy, and speaker invitation: MSD; Other, Personal, Advisory Board, Consultancy, speaker invitation: Pierre Fabre; Other, Personal, Advisory Board, Consultancy, speaker invitation: Sanofi. A.M. Di Giacomo: Other, Personal, Invited Speaker, Advisory Board, Consultancy: BMS; Other, Personal, Invited Speaker, Advisory Board, Consultancy: MSD; Other, Personal, Invited Speaker, Advisory Board, Consultancy: Sanofi; Other, Personal, Invited Speaker, Advisory Board, Consultancy: Pierre Fabre; Other, Personal, Advisory Board, Consultancy: Glaxo Smith Kline; Other, Personal, Advisory Board, Consultancy: Incyte. P. Quaglino: Other, Personal, Invited Speaker, Advisory Board, Travel expense: BMS; Other, Personal, Invited Speaker, Advisory Board, Travel expense: MSD; Other, Personal, Invited Speaker, Advisory Board, Travel expense: Novartis; Other, Personal, Invited Speaker, Advisory Board, Travel expense: Pierre Fabre. V. Chiarion Sileni: Other, Personal, Other, Meeting Travel expenses: BMS; Other, Personal, Other, Consultancy, Travel expenses: Pierre Fabre; Other, Personal, Invited Speaker: Novartis; Other, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker, Consultancy: Merck-Serono. P. Queirolo: Other, Personal, Advisory Board: Roche; Other, Personal, Advisory Board, Lecture fees: Novartis; Other, Personal, Advisory Board, Lecture fees: MSD; Other, Personal, Advisory Board: BMS; Other, Personal, Advisory Board: Merck; Other, Personal, Advisory Board: Sun Pharma; Other, Personal, Advisory Board, Lecture fees: Sanofi; Other, Personal, Advisory Board: Pierre Fabre. F. Cognetti: Other, Personal, Advisory Board, Participation to Congresses: GSK; Other, Personal, Advisory Board, Participation to Congresses: Roche; Other, Personal, Other, Scientific Consultancy, Participation to Congresses: Pfizer; Other, Personal, Advisory Board, Participation to Congresses: AstraZeneca; Other, Personal, Advisory Board, Participation to Congresses: Eli Lilly; Other, Personal, Other, Scientific Consultancy: Genomic Health. M. Mandala': Other, Personal, Advisory Board: Novartis; Other, Personal, Advisory Board: BMS; Other, Personal, Advisory Board: MSD; Other, Personal, Advisory Board: Pierre Fabre; Other, Personal, Advisory Board: Sanofi. M. Guidoboni: Other, Personal, Advisory Board: BMS; Other, Personal, Research Grant: MSD; Other, Personal, Advisory Board: Pierre Fabre; Other, Personal, Advisory Board: Novartis. R. Depenni: Other, Personal, Advisory Role: BMS; Other, Personal, Advisory Role: MSD; Other, Personal, Advisory Role: Novartis; Other, Personal, Advisory Role: Pierre Fabre. F. Consoli: Other, Personal, Advisory Role: BMS; Other, Personal, Advisory Role: MSD; Other, Personal, Advisory Role: Novartis. T. Troiani: Other, Personal, Invited Speaker: Novartis; Other, Personal, Invited Speaker: BMS; Other, Personal, Invited Speaker: Sanofi; Other, Personal, Invited Speaker: Roche; Other, Personal, Invited Speaker: Servier; Other, Personal, Invited Speaker: Amgen; Other, Personal, Invited Speaker: Bayer. M. Guida: Other, Personal, Advisory Role: BMS; Other, Personal, Advisory Role: MSD; Other, Personal, Advisory Role: Novartis; Other, Personal, Advisory Role: Pierre Fabre. R. Marconcini: Other, Personal, Invited Speaker, Advisory role: BMS; Other, Personal, Invited Speaker, Advisory role: Novartis; Other, Personal, Invited Speaker, Advisory role: Ipsen; Other, Personal, Invited Speaker, Advisory role: Pierre Fabre; Other, Personal, Invited Speaker, Advisory role: MSD; Other, Personal, Invited Speaker: Roche. P.F. Ferrucci: Other, Personal, Invited Speaker: BMS; Other, Personal, Invited Speaker: MSD; Other, Personal, Invited Speaker: Roche; Other, Personal, Invited Speaker: Novartis; Other, Personal, Invited Speaker: Pierre Fabre. M. Bersanelli: Other, Personal, Invited Speaker, Honoraria, Research funding: BMS; Other, Personal, Invited Speaker, Honoraria, Research funding: Novartis; Other, Personal, Invited Speaker, Honoraria, Research funding: AstraZeneca; Other, Personal, Invited Speaker, Honoraria: Pierre Fabre; Other, Personal, Invited Speaker, Honoraria, Research funding: Pfizer; Other, Personal, Research Grant: Sanofi Genzyme; Other, Personal, Research Grant: Roche SpA; Other, Personal, Research Grant: Seqirus UK. E. rossi: Other, Personal, Other, Consultancy: MSD. M. Aglietta: Other, Personal, Advisory Role, Consultancy: Bayer; Other, Personal, Advisory Role, Consultancy: Novartis; Other, Personal, Advisory Role, Consultancy, Travel expenses: BMS; Other, Personal, Advisory Role, Consultancy, Travel expenses: Merck; Other, Personal, Other, Research Funding: AstraZeneca; Other, Personal, Other, Research Funding: Pharmamar; Other, Personal, Other, Travel expenses: Tesaro. P.A. Ascierto: Other, Personal, Advisory Role, Consultant: BMS; Other, Personal, Advisory Role, Consultant: Roche-Genentech; Other, Personal, Advisory Role, Consultant: MSD; Other, Personal, Advisory Role, Consultant: Novartis; Other, Personal, Advisory Role, Consultant: Array; Other, Personal, Advisory Role, Consultant: Merck Serono; Other, Personal, Advisory Role, Consultant: Pierre Fabre; Other, Personal, Advisory Role, Consultant: Incyte; Other, Personal, Advisory Role, Consultant: Newlinks Genetics; Other, Personal, Advisory Role, Consultant: GENMAB; Other, Personal, Advisory Role, Consultant: Medimmune; Other, Personal, Advisory Role, Consultant: AstraZeneca; Other, Personal, Advisory Role, Consultant: SINDAX; Other, Personal, Advisory Role, Consultant: SUN PHARMA; Other, Personal, Advisory Role, Consultant: Sanofy; Other, Personal, Advisory Role, Consultant: IDERA; Other, Personal, Advisory Role, Consultant: Ultimovacs; Other, Personal, Advisory Role, Consultant: Sandoz; Other, Personal, Advisory Role, Consultant: Immunocore; Other, Personal, Advisory Role, Consultant: 4SC; Other, Personal, Stocks/Shares: PrimeVax; Other, Institutional, Other, Research Funds: BMS; Other, Institutional, Other, Research Funds: Roche Genentech; Other, Institutional, Other, Research Funds: ARRAY; Other, Personal, Other, Travel Support: MSD; Financial Interests, Personal, Other, Consultant: Alkermes; Financial Interests, Personal, Other, Consultant: Italfarmaco; Financial Interests, Personal, Other, Consultant: Nektar. All other authors have declared no conflicts of interest.