Safety Profile of Nivolumab Plus Ipilimumab Combination ... · Yau T, et al. Presented at the...

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

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.

CheckMate 040 Nivolumab Plus Ipilimumab

Combination Cohort Study Design

Nivolumab

240 mg IV

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

• 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

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.

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.

NIVO1/IPI3 Q3W

n = 50

NIVO3/IPI1 Q3W

n = 49

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)

Patient Exposure and Disposition

CI, confidence interval; NA, not applicable.

• 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%)

NIVO1/IPI3 Q3W

n = 49

NIVO3/IPI1 Q3W

n = 49

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)

Efficacy Results

CR, complete response; NE, not estimable; PD, progressive disease; PR, partial response; SD, stable disease.

• 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

NIVO1/IPI3 Q3W

n = 50

NIVO3/IPI1 Q3W

n = 49

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

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)

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.

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

n = 48

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).

• 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 = 49

n = 48

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.

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.

n = 49

n = 48

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

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

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 20 40 60 80 100 120 160140

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 20 40 60 80 100 120 160140

4.0–120.111.1

3.0–19.1

0.6–141.3+22.3

0.1–55.64.4

2.0–25.94.1

0.1–33.42.4

123.10.1–143.3+

6.3+ –153.1+

TTO, time to onset; TTR, time to resolution.

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

– 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.

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

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