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1 Overall Survival (OS) Analysis From an Expanded Access Program (EAP) of Nivolumab (NIVO) in Combination with Ipilimumab (IPI) in Patients with Advanced Melanoma (MEL) David Hogg, Paul B. Chapman, 2 Mario Sznol, 3 Christopher D. Lao, 4 Rene Gonzalez, 5 Gregory A. Daniels, 6 Michael Smylie, 7 Ragini R. Kudchadkar, 8 John A. Thompson, 9 William H. Sharfman, Michael B. Atkins, Anna C. Pavlick, 2 Joel Jiang, 3 Alexandre Avila, 3 Sheena Demelo, 3 F. Stephen Hodi 4 Princess Margaret Cancer Centre, Toronto, ON, Canada; 2 Memorial Sloan Kettering Cancer Center, New York, NY, USA; 3 Yale University School of Medicine and Yale Cancer Center, New Haven, CT, USA; 4 University of Michigan, Ann Arbor, Michigan, USA; 5 University of Colorado Cancer Center, Aurora, CO, USA; 6 University of California, San Diego, Moores Cancer Center, La Jolla, CA, USA; 7 Cross Cancer Institute, Edmonton, Alberta, Canada; 8 Emory University School of Medicine, Winship Cancer Institute, Atlanta, Georgia, USA; 9 University of Washington, Seattle Cancer Care Alliance, Seattle, WA, USA; Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA; Georgetown-Lombardi Comprehensive Cancer Center, Washington DC, USA; 2 New York University Langone Medical Center, New York, NY, USA; 3 Bristol-Myers Squibb, Princeton, NJ, USA; 4 Dana-Farber Cancer Institute, Boston, MA, USA david.hogg@uhn.ca
2 Background Nivolumab (NIVO; anti-pd-) and ipilimumab (IPI; anti-ctla-4), alone and in combination, are approved for the treatment of advanced melanoma (MEL),2 Phase II and III trials showed improved efficacy for NIVO+IPI vs IPI alone in patients with MEL, but with a higher frequency of adverse events (AEs) 3,4 In the phase II CheckMate 69 trial, the 2-year overall survival (OS) rate was 64% for all patients in the NIVO+IPI group vs 45% for IPI (-year rates were 73% and 65%) 5 In the phase III CheckMate 67 trial, 2-year OS rates were 64% for NIVO+IPI, 59% for NIVO, and 45% for IPI (-year rates were 73%, 74%, and 67%, respectively) 6. OPDIVO (nivolumab) [package insert]. Princeton, NJ: Bristol-Myers Squibb; YERVOY (ipilimumab) [package insert]. Princeton, NJ: Bristol-Myers Squibb; October Larkin J et al. N Engl J Med. 25;373: Postow MA et al. N Engl J Med. 25;372: Postow MA et al. Presented at the AACR 26 meeting. Abstract CT2. 6. Larkin J et al. Presented at the AACR 27 Annual Meeting. Abstract CT75. 2
3 CheckMate 28 CheckMate 28 (NCT286249) is a North American expanded access program (EAP) Objective was to provide NIVO+IPI combination therapy in patients with MEL who may have progressed on other therapies, but who were treatment-naïve for anti-ctla-4 and anti-pd- United States (US) cohort: 58 treated patients with a minimum follow-up of year Canada cohort: 52 treated patients with a minimum follow-up of 6 months We previously reported safety data on 252 patients treated in the US with 6 months of follow-up Here, we report the first OS data for all patients, as well as updated safety data in all patients. Chapman PB et al. Presented at the ASCO 26 Annual Meeting. Abstract
4 Study Design and Assessments NIVO mg/kg + IPI 3 mg/kg Q3W 4 NIVO 3 mg/kg Q2W Treat until progression or unacceptable toxicity (48 weeks maximum) Safety assessments included the incidence of treatment-related Aes and select AEs (ie, those with a potential immunologic etiology) Overall survival was analyzed for all patients based on Kaplan-Meier survival curves Anti-tumor response assessments were not captured within the EAP 4
5 Patient Demographics, Characteristics, and Disposition Total (N=732) Of 732 treated patients, 3% had received prior therapies US (n=58) Canada (n=52) Male, n (%) 466 (64) 366 (63) (66) Median age, (range) 59 (8 87) 59 (8 87) 57 (27 8) BRAF mutant, n (%) 36 (43) 24 (4) 76 (5) LDH > ULN, n (%) 226 (3) 69 (29) 57 (38) LDH > 2x ULN, n (%) 69 (9) 53 (9) 6 () M stage at study entry, n (%) M 76 () 65 () (7) Ma 98 (3) 8 (4) 8 (2) Mb 37 (9) 99 (7) 38 (25) Mc with brain metastases 9 (2) 7 (2) 2 (3) Mc without brain metastases 286 (39) 223 (38) 63 (4) Median duration of therapy was.8 months for NIVO and.4 months for IPI Median number of NIVO+IPI combination doses was 3 (range: -4) and 44% of patients continued onto NIVO maintenance Overall, at the time of database lock, 9% of patients were still receiving treatment LDH = lactate dehydrogenase; ULN = upper limit of normal 5
6 OS (%) Overall Survival CheckMate 28 and Clinical Trials Events/number at risk Median OS, Months (95% CI) Number of patients at risk NIVO+IPI 27/732 NR (NR, NR) % Months NIVO+IPI CI = confidence interval; NR = not reached 6
7 OS (%) Overall Survival for LDH Subpopulations Events/number at risk Median OS, Months (95% CI) Number of patients at risk % 7 Months LDH ULN 47/462 NR (NR, NR) LDH > ULN 7/ (3.4, NR) LDH > 2 ULN 29/69.5 (7.5, NR) 6 6% % LDH ULN LDH > ULN LDH > 2 ULN CI = confidence interval; LDH = lactate dehydrogenase; NR = not reached; ULN = upper limit of normal 7
8 OS (%) Overall Survival for Melanoma Subtype Subpopulation Events/number at risk Median OS, Months (95% CI) Number of patients at risk 9 Mucosal / (3.5, NR) Ocular/Uveal / (6., NR) % % Months Mucosal Ocular/uveal CI = confidence interval; NR = not reached 8
9 Overall Safety Summary Total patients (N=732) n (%) Any grade Grade 3/4 Patients with any treatment-related AE 686 (94) 364 (5) Patients with treatment-related AEs leading to discontinuation 235 (32) 84 (25) Treatment-related deaths a 4 () Treatment-related select (immune-related) AEs were similar to clinical trial studies Most common all grade AEs were skin (62%), gastrointestinal (43%), and hepatic (33%) Most common grade 3-4 AEs were gastrointestinal (6%), hepatic (4%), and skin (5%) a Includes multiorgan failure, congestive heart failure, sepsis due to grade 4 colitis, and diffuse myositis and myocarditis. 9
10 Conclusions This large EAP of North American patients showed -year OS rates consistent with those reported in clinical trials in patients with untreated MEL Although -year survival rates were decreased in poor prognostic subgroups, OS was still >4% in patients with elevated LDH and those with ocular/uveal MEL subtypes -year OS rates were 73% for NIVO+IPI in both CheckMate 69 and 67 2 in treatment-naive patients with advanced MEL Grade 3-4 treatment-related AEs were reported in 5% of patients No new safety signals were identified NIVO+IPI treatment demonstrated survival outcomes and a safety profile consistent with clinical trial data in this real-world population. Postow MA et al. Presented at the AACR 26 meeting. Abstract CT2. 2. Larkin J et al. Presented at the AACR 27 Annual Meeting. Abstract CT75.
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