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13th ILCA Annual Conference
20 ► 22 September 2019 │Chicago, USA
13th Annual Conference20 ► 22 September 2019
Chicago, USA
Safety Profile of Nivolumab Plus Ipilimumab
Combination Therapy in Patients With Advanced
Hepatocellular Carcinoma in the CheckMate 040 StudyAnthony B. El-Khoueiry,1 Chiun Hsu,2 Yoon-Koo Kang,3 Tae-You Kim,4 Armando Santoro,5 Bruno Sangro,6
Ignacio Melero,7 Masatoshi Kudo,8 Ming-Mo Hou,9 Ana Matilla,10 Francesco Tovoli,11 Jennifer J. Knox,12 Aiwu Ruth He,13
Bassel El-Rayes,14 Mirelis Acosta-Rivera,15 Jaclyn Neely,16 Yun Shen,16 Jeffrey Anderson,16 Thomas Yau17
1USC Norris Comprehensive Cancer Center, Los Angeles, CA, USA ; 2National Taiwan University Hospital, Taipei, Taiwan; 3Asan Medical Center, University of Ulsan, Seoul, South Korea; 4Seoul National University, Seoul, South Korea; 5Istituto Clinico Humanitas, Rozzano, Italy; 6Clinica Universidad de Navarra and CIBEREHD, Pamplona, Spain; 7Universidad de Navarra,
Pamplona, Spain; 8Kindai University Faculty of Medicine, Osaka, Japan; 9Chang Gung Memorial Hospital, Taipei, Taiwan; 10Servicio de Digestivo, Hospital General Universitario Gregorio
Marañón, Madrid, Spain; 11Department of Medical & Surgical Sciences, University of Bologna, Bologna, Italy; 12Princess Margaret Cancer Centre, Toronto, Canada; 13Georgetown University Hospital, Washington, DC, USA; 14Emory University Winship Cancer Institute, Atlanta, GA, USA; 15Fundacion de Investigacion, San Juan, Puerto Rico;
16Bristol- Myers Squibb, Princeton, NJ, USA; 17University of Hong Kong, Hong Kong, China
13th ILCA Annual Conference
20 ► 22 September 2019 │Chicago, USA
Introduction
• Nivolumab monotherapy is approved in several countries for sorafenib-treated patients with HCC based on
data from the CheckMate 040 study (NCT01658878), which reported an ORR of 14% and median OS of 15
months1
• The clinical efficacy observed with nivolumab monotherapy has led to investigation of nivolumab combination
therapy to achieve durable responses in higher proportions of patients
• The combination of nivolumab, a PD-1 checkpoint inhibitor, and ipilimumab, a CTLA-4 immune checkpoint
inhibitor, promotes synergistic antitumor immune response using distinct but complementary mechanisms2
and has shown durable responses in other tumor types (RCC, NSCLC, melanoma, and MSI-H/dMMR CRC)3-6
• The first report on the combination of nivolumab plus ipilimumab in sorafenib-treated patients with advanced
HCC indicated that the combination led to robust and durable responses in sorafenib-treated patients7
• Here we report results for the nivolumab plus ipilimumab combination in sorafenib-treated patients with
advanced HCC, with a focus on hepatic safety
CTLA-4, cytotoxic T-lymphocyte–associated protein 4; HCC, hepatocellular carcinoma; MSI-H/dMMR CRC, microsatellite instability–high/DNA mismatch repair–deficient metastatic
colorectal cancer; NSCLC, non-small cell lung cancer; ORR, objective response rate; PD-1, programmed death-1; RCC, renal cell carcinoma.
1. El-Khoueiry AB, et al. American Society of Clinical Oncology – Gastrointestinal Cancers Symposium 2018; January 18–20, 2018; San Francisco, CA. Abstract 475;
2. Das R, et al. J Immunol 2015;194:950–959; 3. Hellmann MD, et al. Lancet Oncol 2017;18:31–41; 4. Hodi FS, et al. Lancet Oncol 2016;17:1558–1568; 5. Motzer RJ, et al.
N Engl J Med 2018;378:1277–1290; 6. Overman MJ, et al. J Clin Oncol 2018;36:773–779; 7. Yau T, et al. American Society of Clinical Oncology Annual Meeting 2019; Poster 4012.
13th ILCA Annual Conference
20 ► 22 September 2019 │Chicago, USA
CheckMate 040 Nivolumab Plus Ipilimumab
Combination Cohort Study Design
Nivolumab
240 mg IV
Q2W
flat dose
Study endpoints
Primary
• Safety and tolerability
using NCI CTCAE v4.0
• ORR and DOR based on
investigator assessmenta
Secondary
• DCR • TTP
• PFS • TTR
• OS
Other
• BOR and ORR based on
BICR-assessed tumor
responsea
Arm C:
NIVO3 Q2W +
IPI1 Q6W
Arm B:
NIVO3 + IPI1
Q3W × 4
Arm A:
NIVO1 + IPI3
Q3W × 4
R
1:1:1
Unacceptabletoxicity
ordisease
progression
BICR, blinded independent central review; BOR, best overall response; CP, Child-Pugh; DCR, disease control rate; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology
Group performance status; HBV, hepatitis B virus; HCC, hepatocellular carcinoma; HCV, hepatitis C virus; IPI1, ipilimumab 1 mg/kg; IPI3, ipilimumab 3 mg/kg; IV, intravenous; NCI CTCAE,
National Cancer Institute Common Terminology Criteria for Adverse Events; NIVO1, nivolumab 1 mg/kg; NIVO3, nivolumab 3 mg/kg; ORR, objective response rate; OS, overall survival;
PFS, progression-free survival; Q2W, every 2 weeks; Q3W, every 3 weeks; Q6W, every 6 weeks; R, randomization; RECIST, Response Evaluation Criteria in Solid Tumors; TTP, time to
progression; TTR, time to response.
Key eligibility criteria
• Advanced HCC,
sorafenib treated,
intolerant, or
progressors
• Uninfected, HCV
infected, or HBV
infected
• CP score A5–A6
• ECOG PS 0–1
aUsing RECIST v1.1.
Minimum follow-up at time of data cutoff: 28 months.
13th ILCA Annual Conference
20 ► 22 September 2019 │Chicago, USA
Patient Demographics and Baseline Characteristics
AFP, alpha-fetoprotein; BCLC, Barcelona Clinic Liver Cancer.
Yau T, et al. Presented at the American Society of Clinical Oncology Annual Meeting 2019; May 31–June 4, 2019; Chicago, IL. Poster 4012.
Arm A
NIVO1/IPI3 Q3W
n = 50
Arm B
NIVO3/IPI1 Q3W
n = 49
Arm C
NIVO3 Q2W/IPI1 Q6W
n = 49
Median age (range), years 60.5 (18–80) 65 (34–83) 58 (32–79)
Male, n (%) 43 (86) 37 (76) 40 (82)
Race, n (%)
Asian 37 (74) 27 (55) 30 (61)
White 12 (24) 20 (41) 15 (31)
Black 1 (2) 1 (2) 3 (6)
BCLC stage C, n (%) 43 (86) 45 (92) 46 (94)
Child-Pugh score of 5 or 6, n (%) 50 (100) 47 (96) 47 (96)
Vascular invasion, n (%) 18 (36) 13 (27) 19 (39)
Extrahepatic spread, n (%) 40 (80) 40 (82) 42 (86)
AFP ≥ 400 µg/L, n (%) 25 (50) 18 (37) 22 (45)
Etiology, n (%)
Uninfected 13 (26) 11 (22) 9 (18)
HBV infected 28 (56) 21 (43) 26 (53)
HCV infected 7 (14) 14 (29) 12 (24)
Prior sorafenib treatment, n (%) 50 (100) 48 (98) 48 (98)
Reason for sorafenib discontinuation
Disease progression 44 (88) 41 (85) 38 (79)
Toxicity 5 (10) 6 (12.5) 10 (21)
Other 1 (2) 2 (4) 1 (2)
13th ILCA Annual Conference
20 ► 22 September 2019 │Chicago, USA
Patient Exposure and Disposition
CI, confidence interval; NA, not applicable.
Yau T, et al. Presented at the American Society of Clinical Oncology Annual Meeting 2019; May 31–June 4, 2019; Chicago, IL. Poster 4012.
• Disease progression was the most common reason for treatment discontinuation, with the
lowest rate of discontinuation due to disease progression observed in arm A (51%)
Arm A
NIVO1/IPI3 Q3W
n = 49
Arm B
NIVO3/IPI1 Q3W
n = 49
Arm C
NIVO3 Q2W/IPI1 Q6W
n = 48
Median doses of nivolumab during combination period (range), n 4 (1–4) 4 (1–4) 9 (1–77)
Median doses of nivolumab during monotherapy period (range), n 24 (1–71) 27.5 (3–62) NA
Median doses of ipilimumab (range), n 4 (1–4) 4 (1–4) 3 (1–26)
Continuing treatment, n (%) 8 (16) 6 (12) 9 (19)
Reasons for discontinuation, n (%)
Disease progression 25 (51) 34 (69) 33 (69)
Study-drug toxicity 11 (22) 3 (6) 1 (2)
Other 5 (10) 6 (12) 5 (10)
Median follow-up (range), months 30.8 (28.2–36.9) 30.7 (28.6–36.9) 30.7 (28.4–36.9)
Median duration of therapy (95% CI), months 5.1 (2.7–9.3) 2.3 (1.4–6.3) 4.0 (2.1–6.7)
13th ILCA Annual Conference
20 ► 22 September 2019 │Chicago, USA
Efficacy Results
CR, complete response; NE, not estimable; PD, progressive disease; PR, partial response; SD, stable disease.
Yau T, et al. Presented at the American Society of Clinical Oncology Annual Meeting 2019; May 31–June 4, 2019; Chicago, IL. Poster 4012.
• Similar ORR, DCR, and DOR were observed across treatment arms, with consistently high ORR (> 30%) achieved
in all treatment arms
• The greatest survival benefit was observed in arm A, with a median OS of 22.8 months and the highest OS rate of
44% through 30 months
Arm A
NIVO1/IPI3 Q3W
n = 50
Arm B
NIVO3/IPI1 Q3W
n = 49
Arm C
NIVO3 Q2W/
IPI1 Q6W
n = 49
ORR by BICR using RECIST v1.1, n (%)
16 (32) 15 (31) 15 (31)
BOR, n (%)
CR 4 (8) 3 (6) 0
PR 12 (24) 12 (24) 15 (31)
SD 9 (18) 5 (10) 9 (18)
PD 20 (40) 24 (49) 21 (43)
Unable to determine 3 (6) 4 (8) 4 (8)
DCR, n (%) 27 (54) 21 (43) 24 (49)
Median TTR (range), months
2.0 (1.1–12.8) 2.6 (1.2–5.5) 2.7 (1.2–8.7)
Median DOR (range), months
17.5 (4.6 to 30.5+)
22.2 (4.2 to 29.9+)
16.6 (4.1+ to 32.0+)
Time (months)
0 3 6 9 12 15 18 21 24 27 30 33 36 39
0
10
20
30
50
100
40
60
70
80
90
Ove
rall
su
rviv
al
(%)
Arm B mOS (95% CI) = 12.5 mo (7.6–16.4)
Arm C mOS (95% CI) = 12.7 mo (7.4–33.0)
Arm A mOS (95% CI) = 22.8 mo (9.4–NE)
13th ILCA Annual Conference
20 ► 22 September 2019 │Chicago, USA
Summary of TRAEs by CategoryArm A
NIVO1/IPI3 Q3Wn = 49
Arm B NIVO3/IPI1 Q3W
n = 49
Arm C NIVO3 Q2W/IPI1 Q6W
n = 48
Any grade Grade 3–4 Any grade Grade 3–4 Any grade Grade 3–4
Any TRAE, n (%) 46 (94) 26 (53) 35 (71) 14 (29) 38 (79) 15 (31)
Skin and subcutaneous tissue 30 (61) 4 (8) 24 (49) 2 (4) 23 (48) 1 (2)
Investigations (including liver laboratory abnormalities) 24 (49) 16 (33) 21 (43) 11 (22) 15 (31) 7 (15)
General and administration site 19 (39) 2 (4) 15 (31) 0 16 (33) 0
Gastrointestinal 18 (37) 3 (6) 18 (37) 1 (2) 17 (35) 2 (4)
Endocrine 16 (33) 1 (2) 9 (18) 1 (2) 9 (19) 1 (2)
Metabolism and nutrition 14 (29) 7 (14) 6 (12) 2 (4) 6 (13) 1 (2)
Respiratory, thoracic, and mediastinal 7 (14) 1 (2) 2 (4) 0 3 (6) 0
Nervous system 7 (14) 0 6 (12) 0 2 (4) 0
Musculoskeletal and connective tissue 6 (12) 0 3 (6) 0 6 (13) 0
Hepatobiliary 3 (6) 3 (6) 1 (2) 0 1 (2) 0
TRAE, treatment-related adverse event.
• Although rates of any-grade TRAEs were higher in arm A, the types of TRAEs observed were similar across
treatment arms
• No new safety signals were observed, and most TRAEs were manageable and reversible
• Serious TRAEs were reported in 11 patients (22%) in arm A, 9 patients (18%) in arm B, and 7 patients (15%) in arm C – One serious hepatobiliary disorder was reported in arm A (drug-induced liver injury); 3 serious hepatic investigations were reported (elevated AST in arm
A; elevated AST and elevated ALT in arm B)
Listed in the table are any-grade TRAEs that occurred in ≥10% of patients in any arm and grade 3/4 TRAEs that occurred in ≥5% of patients in
any arm. Includes events reported between first dose and 30 days after last dose of study therapy.
13th ILCA Annual Conference
20 ► 22 September 2019 │Chicago, USA
Hepatic Investigations and Hepatobiliary TRAEs
• Increased AST and ALT were the most common abnormalities in hepatic investigations in all treatment arms, and the vast majority were without concomitant bilirubin elevation
• A total of 5 patients had hepatobiliary TRAEs (3 in arm A and 1 each in arms B and C)
• Four patients had hepatic TRAEs leading to discontinuation: 2 in arm A (ALT increased and drug-induced liver injuryb) and 2 in arm B (AST increased)
System Organ Class
Arm A NIVO1/IPI3 Q3W
n = 49
Arm B NIVO3/IPI1 Q3W
n = 49
Arm C NIVO3 Q2W/IPI1 Q6W
n = 48
Any grade Grade 3–4 Any grade Grade 3–4 Any grade Grade 3–4
Investigations,a n (%) 24 (49) 16 (33) 21 (43) 11 (22) 15 (31) 7 (15)
AST increased 10 (20) 8 (16) 10 (20) 4 (8) 6 (13) 2 (4)
ALT increased 8 (16) 4 (8) 7 (14) 3 (6) 4 (8) 0
Blood bilirubin increased 3 (6) 0 0 0 2 (4) 0
Liver function test abnormal 1 (2) 1 (2) 0 0 0 0
Blood alkaline phosphatase increased 1 (2) 0 2 (4) 1 (2) 3 (6) 0
Transaminases increased 0 0 1 (2) 1 (2) 0 0
Hepatobiliary, n (%) 3 (6) 3 (6) 1 (2) 0 1 (2) 0
Hepatitis 2 (4) 2 (4) 0 0 0 0
Drug-induced liver injuryb 1 (2) 1 (2) 0 0 0 0
Hepatocellular injury 0 0 1 (2) 0 0 0
Hypertransaminasemia 0 0 0 0 1 (2) 0
ALT, alanine aminotransferase; AST, aspartate aminotransferase; ULN, upper limit of normal.
aTotal includes all investigations; individual hepatic investigations are reported. bDrug induced liver injury was reported per investigator;
however, drug-induced liver injury did not meet protocol-specified definition of elevated bilirubin (> 2× ULN) and ALT (> 10× ULN).
13th ILCA Annual Conference
20 ► 22 September 2019 │Chicago, USA
• Hepatic select TRAEs were reported in 13 patients (27%) in arm A, 12 patients (24%) in arm B, and 8 patients (17%) in arm C
• Systemic corticosteroids were used to treat select TRAEs in 25 patients (51%) in arm A, 12 patients (24%) in arm B, and 11 patients (23%) in arm C
Summary of Select TRAEs
n (%)
Arm A NIVO1/IPI3 Q3W
n = 49
Arm B NIVO3/IPI1 Q3W
n = 49
Arm C NIVO3 Q2W/IPI1 Q6W
n = 48
Any grade Grade 3–4 Any grade Grade 3–4 Any grade Grade 3–4
Skin 29 (59) 4 (8) 24 (49) 2 (4) 21 (44) 1 (2)
Endocrine 16 (33) 1 (2) 9 (18) 1 (2) 10 (21) 1 (2)
Hepatic 13 (27) 11 (22) 12 (24) 6 (12) 8 (17) 2 (4)
Aspartate aminotransferase increased 10 (20) 8 (16) 10 (20) 4 (8) 6 (13) 2 (4)
Alanine aminotransferase increased 8 (16) 4 (8) 7 (14) 3 (6) 4 (8) 0
Blood alkaline phosphatase increased 1 (2) 0 2 (4) 1 (2) 3 (6) 0
Blood bilirubin increased 3 (6) 0 0 0 2 (4) 0
Hepatitis 2 (4) 2 (4) 0 0 0 0
Drug-induced liver injury 1 (2) 1 (2) 0 0 0 0
Liver function test abnormal 1 (2) 1 (2) 0 0 0 0
Transaminases increased 0 0 1 (2) 1 (2) 0 0
Gastrointestinal 13 (27) 3 (6) 7 (14) 1 (2) 8 (17) 1 (2)
Pulmonary 4 (8) 1 (2) 0 0 0 0
Hypersensitivity/infusion reaction 4 (8) 0 1 (2) 0 1 (2) 0
Renal 0 0 1 (2) 0 1 (2) 1 (2)
Select TRAEs are events with a potential inflammatory mechanism requiring more frequent monitoring and/or unique intervention such as
immunosuppressants and/or endocrine replacement therapy.
13th ILCA Annual Conference
20 ► 22 September 2019 │Chicago, USA
Summary of IMAEs
• Higher rates of IMAEs were observed in arm A compared with arms B and C, with similar rates of AEs observed in arms B and C
• The majority of IMAEs resolved across treatment arms, including hepatic IMAEs; in arm A, 90% of patients had resolution of
hepatic IMAEs– Of the 10 patients in arm A who had a hepatic IMAE, 7 received glucocorticoids (≥ 40 mg of prednisone per day or equivalent) for a median of 2
weeks (range, 0.4–147.6 weeks)
• No patients experienced a recurrence of any category of IMAE after rechallenge with nivolumab or ipilimumab
AE, adverse event; IMAE, immune-mediated adverse event.
Yau T, et al. Presented at the American Society of Clinical Oncology Annual Meeting 2019; May 31–June 4, 2019; Chicago, IL. Poster 4012.
n (%)
Arm A NIVO1/IPI3 Q3W
n = 49
Arm B NIVO3/IPI1 Q3W
n = 49
Arm C NIVO3 Q2W/IPI1 Q6W
n = 48
Any grade Grade 3–4 Any grade Grade 3–4 Any grade Grade 3–4
Rash 17 (35) 3 (6) 14 (29) 2 (4) 8 (17) 0
Hepatitis 10 (20) 10 (20) 6 (12) 5 (10) 3 (6) 3 (6)
Adrenal insufficiency 9 (18) 2 (4) 3 (6) 0 3 (6) 0
Diarrhea/colitis 5 (10) 3 (6) 1 (2) 1 (2) 1 (2) 1 (2)
Pneumonitis 5 (10) 3 (6) 0 0 0 0
Nephritis/renal dysfunction 0 0 1 (2) 0 1 (2) 1 (2)
Hypersensitivity 0 0 1 (2) 1 (2) 1 (2) 0
Hypophysitis 1 (2) 0 0 0 1 (2) 1 (2)
Hyperthyroidism 0 0 1 (2) 0 1 (2) 0
Hypothyroidism/thyroiditis 0 0 0 0 1 (2) 0
Diabetes mellitus 0 0 0 0 0 0
13th ILCA Annual Conference
20 ► 22 September 2019 │Chicago, USA
Time to Onset and Resolution of Select TRAEs
• In general, select TRAEs occurred early during treatment; time to onset for hepatic select TRAEs ranged from 4.1 to 5.3 weeks
• The vast majority of select TRAEs resolved, with the exception of endocrine events; across all treatment arms, ≈90% of hepatic
select TRAEs resolved
aTime to onset measured from treatment initiation and time to resolution measured from select TRAE onset; bIn arm A, 4 patients had hypersensitivity/infusion reactions; all
events resolved (median TTO: 10.3 weeks [range: 0.1–21.1]; median TTR: 0.4 week [range: 0.1–9.1]); cIn arm B, 1 patient had a renal select TRAE (TTO: 15.0 weeks;
TTR: 6.0 weeks), and 1 patient had a hypersensitivity/infusion reaction (TTO: 61.4 weeks; TTR: 0.1 week); dIn arm C, 1 patient had an unresolved renal select TRAE (TTO:
34.3 weeks), and 1 patient had a hypersensitivity/infusion reaction (TTO: 2.0 weeks; TTR: 1.0 week).
Patients,
n/n (%)
Arm A (NIVO1/IPI3 Q3W)a,b
Skin resolution 16/29 (55)
5/16 (31)
Skin onset
Endocrine resolution
Endocrine onset
Hepatic resolution 12/13 (92)
13/13 (100)
4/4 (100)
Hepatic onset
Gastrointestinalresolution
Gastrointestinalonset
Pulmonary resolution
Pulmonary onset
0 20 40 60 80 100 120 160140
Weeks
5.9–70.312.2
0.4–58.73.1
0.6–76.14.3
2.4–9.03.2
0.1–29.13.1
2.9–16.05.3
0.3–90.17.3
5.4–76.021.5
63.1 0.6–149.1+
1.9–145.6+
Patients,
n/n (%)
Arm B (NIVO3/IPI1 Q3W)a,c
16/24 (67)
3/9 (33)
11/12 (92)
7/7 (100)
0/0
0 20 40 60 80 100 120 160140
Weeks
5.9–122.16.7
0.6–51.0+4.1
0.3–4.32.4
0.1–108.35.3
3.0–15.04.6
0.3–80.06.3
12.9 0.4–139.0+
6.1–126.1+
Patients,
n/n (%)
Arm C (NIVO3 Q2W/IPI1 Q6W)a,d
11/21 (52)
3/10 (30)
7/8 (88)
5/8 (63)
0/0
0 20 40 60 80 100 120 160140
Weeks
4.0–120.111.1
3.0–19.1
0.6–141.3+22.3
1.0
0.1–55.64.4
2.0–25.94.1
0.1–33.42.4
123.10.1–143.3+
6.3+ –153.1+
12.0
TTO, time to onset; TTR, time to resolution.
13th ILCA Annual Conference
20 ► 22 September 2019 │Chicago, USA
Conclusions
• The combination of nivolumab plus ipilimumab led to clinically meaningful responses in sorafenib-
treated patients, with ORR > 30% in each treatment arm
– Patients in arm A had a median OS of 22.8 months and the highest OS rate of 44% through 30 months
• Nivolumab plus ipilimumab had a manageable safety profile in this patient population with advanced
HCC
– No new safety signals were seen with the addition of ipilimumab in any treatment arms
– The safety profile of nivolumab plus ipilimumab in HCC was consistent with that observed in studies of other
tumor types1-5
– Higher rates of TRAEs, IMAEs, and discontinuation due to study drug toxicity were observed in arm A
compared with arms B and C, with similar rates of AEs observed in arms B and C
– The majority of select TRAEs resolved across treatment arms with steroid use; ≈90% of patients in each arm
had resolution of hepatic select TRAEs
• The favorable benefit/risk profile observed with nivolumab plus ipilimumab warrants further
investigation
– The CheckMate 9DW phase 3 study of this combination in patients with HCC is planned (NCT04039607)1. Hellmann MD, et al. Lancet Oncol 2017;18:31–41; 2. Hodi FS, et al. Lancet Oncol 2016;17:1558–1568; 3. Motzer RJ, et al. N Engl J Med 2018;378:1277–1290; 4. Hammers HJ, et al.
J Clin Oncol 2017;35:3851–3858; 5. Sznol M, et al. J Clin Oncol 2017;35:3815–3822.
13th ILCA Annual Conference
20 ► 22 September 2019 │Chicago, USA
Acknowledgments
• The patients and families, as well as the investigators and participating study
teams, who made this study possible
• Dako, an Agilent Technologies, Inc. company, for collaborative development
of the PD-L1 IHC 28-8 pharmDx assay
• Bristol-Myers Squibb (Princeton, NJ) and ONO Pharmaceutical Company
Ltd. (Osaka, Japan)
• The study was supported by Bristol-Myers Squibb and ONO Pharmaceutical
Co. Ltd.
• All authors contributed to and approved the presentation; professional
medical writing and editorial assistance was provided by Andrea L.
Hammons, PhD, of Parexel International, funded by Bristol-Myers Squibb
13th ILCA Annual Conference
20 ► 22 September 2019 │Chicago, USA
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