Treatment of
From Nov 2016 to May 2019, n.251 patients with untreated, metastatic
69 patients were treated in arm A, 71 in arm B and 69 in arm C. At a median follow-up of 17.5 months (IQR 10.2-23.4– d.b.lock July 2020), we report preliminary data of PFS, ORR and safety. mPFS was 15.8 months in Arm A, 7.2 months in Arm B, and 11.4 months in Arm C. In the 3 Arms 1-year PFS was 60%, 43% and 46% and 2-year PFS was 35%, 38% and 39% respectively. ORR was 82.6% (CR 21.7%) in Arm A, 45.1% (CR 15.5%) in Arm B and 78.3% (CR 29.0%) in Arm C. G3/4 toxicity was 49% in Arm A, 73% in Arm B and 51% in Arm C, while G.3/4 treatment-related adverse events were 28%, 54% and 32%. 18 pts were discontinued due to adverse events, 7 in Arm A, 8 in Arm B and 3 in Arm C.
At a minimum follow up of 1 year, our data confirm what reported in the pivotal studies. Despite the difference in term of mPFS, the 2-yrs PFS rate is similar among the different arms. The study is still ongoing for the completion of the main endpoint (OS).
NCT02631447.
Fondazione Melanoma Onlus.
Bristol Myers Squibb and Array Biopharma.
P.A. Ascierto: Advisory/Consultancy, Research grant/Funding (institution): Bristol Myers-Squibb; Advisory/Consultancy, Research grant/Funding (institution): Roche-Genentech; Advisory/Consultancy, Research grant/Funding (institution): Array; Advisory/Consultancy, Travel/Accommodation/Expenses: Merck Sharp & Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy: Merck Serono; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Incyte; Advisory/Consultancy: Newlink Genetics; Advisory/Consultancy: Genmab; Advisory/Consultancy: MedImmune; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Syndax; Advisory/Consultancy: SunPharma; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Idera; Advisory/Consultancy: Ultimovacs; Advisory/Consultancy: Sandoz; Advisory/Consultancy: Immunocore; Advisory/Consultancy: 4SC; Advisory/Consultancy: Alkermes; Advisory/Consultancy: Italfarmaco; Advisory/Consultancy: Nektar; Advisory/Consultancy: Boehringer-Ingelheim. M. Mandala: Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy: Roche; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Merck Serono. P.F. Ferrucci: Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy: Roche-Genentech; Advisory/Consultancy: Pierre Fabre. P. Rutkowski: Honoraria (self), Advisory/Consultancy: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Pierre Fabre; Honoraria (self), Advisory/Consultancy: Blueprint Medicines; Honoraria (self), Advisory/Consultancy: Eli Lilly; Honoraria (self), Advisory/Consultancy: Amgen. M. Guidoboni: Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Novartis; Research grant/Funding (institution): Merck Sharp & Dohme. A.M. Arance Fernandez: Advisory/Consultancy, Speaker Bureau/Expert testimony: Pierre Fabre; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Bristol Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony: Merck Sharp & Dohme; Advisory/Consultancy, Speaker Bureau/Expert testimony: Merck Serono; Advisory/Consultancy, Speaker Bureau/Expert testimony: Sanofi; Advisory/Consultancy, Speaker Bureau/Expert testimony: Amgen. V. Ferraresi: Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pierre Fabre. E. Maiello: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy: Servier; Advisory/Consultancy: Sanofi Genzyme; Advisory/Consultancy: Roche; Advisory/Consultancy: Merck; Advisory/Consultancy: Eisai; Advisory/Consultancy: Pfizer. M. Guida: Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pierre Fabre. M. Del Vecchio: Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Sanofi. M.T. Fierro: Advisory/Consultancy, Speaker Bureau/Expert testimony: Bristol Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pierre Fabre. P. Queirolo: Advisory/Consultancy: Roche; Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Merck; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Sun Pharma; Advisory/Consultancy: Sanofi. C. Lebbé: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self): Pierre Fabre; Honoraria (self), Advisory/Consultancy: Merck Serono; Honoraria (self), Advisory/Consultancy: Sanofi; Honoraria (self): Pfizer; Honoraria (self): Incyte. I. Melero: Honoraria (self), Advisory/Consultancy, Part of AstraZeneca partners of choice: AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Part of BMS I-ON consortium: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Bioncotech; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Alligator; Honoraria (self): Numab; Honoraria (self), Advisory/Consultancy: F-Star; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Part of Roche imCORE: Roche; Honoraria (self): Bayer; Honoraria (self), Research grant/Funding (self): Merck Serono; Honoraria (self), Advisory/Consultancy: Merck Sharp & Dohme; Honoraria (self): Boston Pharmaceuticals; Honoraria (self): Servier; Research grant/Funding (self): Palo Biopharma. G. Palmieri: Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Incyte; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Roche Genentech. A.M. Grimaldi: Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self): Roche; Travel/Accommodation/Expenses: Sun Pharma; Travel/Accommodation/Expenses: Pierre Fabre; Honoraria (self), Travel/Accommodation/Expenses: Merck Serono. R. Dummer: Advisory/Consultancy, Project focused consulting: Novartis; Advisory/Consultancy, Project focused consulting: Merck Sharp & Dohme; Honoraria (institution), Project focused consulting: Bristol Myers Squibb; Advisory/Consultancy, Project focused consulting: Roche; Advisory/Consultancy, Project focused consulting: Amgen; Advisory/Consultancy, Project focused consulting: Takeda; Advisory/Consultancy, Project focused consulting: Pierre Fabre; Advisory/Consultancy, Project focused consulting: Sun Pharma; Advisory/Consultancy, Project focused consulting: Sanofi; Advisory/Consultancy, Project focused consulting: Catalym; Advisory/Consultancy, Project focused consulting: Second Genome; Advisory/Consultancy, Project focused consulting: Regeneron; Advisory/Consultancy, Project focused consulting: Alligator. V. Chiarion Sileni: Speaker Bureau/Expert testimony: Novartis; Travel/Accommodation/Expenses: Bristol Myers Squibb; Advisory/Consultancy, Travel/Accommodation/Expenses: Pierre Fabre; Speaker Bureau/Expert testimony: Merck Sharp & Dohme. All other authors have declared no conflicts of interest.