1. Phase I/II CheckMate 032: Nivolumab ± Ipilimumab in Advanced SCLC
CCO Independent Conference Highlights* of the 2017 ASCO Annual Meeting; June 2-6, 2017; Chicago, Illinois
*Clinical Care Options (CCO) is an independent medical education organization that provides conference coverage and other unique educational programs for healthcare professionals
This activity is supported by educational grants from AbbVie, Amgen, AstraZeneca, Celgene Corporation, Genentech, Halozyme, Incyte, and Merck & Co., Inc.

2. Nivolumab ± Ipilimumab in Advanced SCLC (CheckMate 032): Background
Few treatment options, poor prognosis for pts with recurrent SCLC
CheckMate 032: phase I/II trial evaluating nivolumab with or without ipilimumab in multiple tumor types including SCLC that progressed after platinum-based treatment
Early data from nonrandomized pt cohort suggested durable responses and promising survival in SCLC
Nivolumab ± ipilimumab included in guidelines for SCLC
Current report presents first results from randomized cohort added to further evaluate nivolumab ± ipilimumab in SCLC
SCLC, small-cell lung cancer.
Slide credit: clinicaloptions.com
Hellmann MD, et al. ASCO Abstract Antonia SJ, et al. Lancet Oncol. 2016;17:

3. CheckMate 032: Study Design
Nivolumab 1 mg/kg +
Ipilimumab 3 mg/kg IV
Q3W x 4 cycles
Nivolumab 3 mg/kg IV
Q2W
Pts with SCLC that progressed after ≥1 prior platinum-based therapy
Nivolumab 3 mg/kg IV
Q2W
Until PD or unacceptable toxicity
PD, progressive disease; RECIST, Response Evaluation Criteria in Solid Tumors; SCLC, small-cell lung cancer.
Primary objective: ORR per RECIST v1.1
Same dosing regimens used for randomized (3:2) and nonrandomized cohorts
Slide credit: clinicaloptions.com
Hellmann MD, et al. ASCO Abstract 8503.

4. Nivolumab + ipilimumab
CheckMate 032: Response Outcomes for Nonrandomized Cohort With Extended Follow-up
Response Characteristic
Nivolumab
(n = 98)
Nivolumab + ipilimumab
(n = 61)
ORR, %
PD-L1 ≥ 1%
PD-L1 < 1% 11 9 14 23 10 32
Median time to response, mos (range)
1.4 ( )
2.0 ( )
Median duration of response, mos (range)
17.9 ( )
14.2 ( )
Ongoing responses at 2 yrs, % 45 36
Slide credit: clinicaloptions.com
Hellmann MD, et al. ASCO Abstract 8503.

5. CheckMate 032: OS for Nonrandomized Cohort With Extended Follow-up
100
Median OS,
Mos (95% CI)
4.1 ( )
7.8 ( )
Minimum Follow-up, Mos 90 80
Nivolumab Nivolumab + ipilimumab 70 60
OS (%) 50
1-yr OS: 40% 40 30
2-yr OS: 26%
1-yr OS: 27% 20 10
2-yr OS: 14% 3 6 9 12 15 18 21 24 27 30 33 36 39
Pts at Risk, n Nivolumab Nivolumab + ipilimumab
Mos
98 61
56 43
39 33
35 28
26 24
21 21
17 19
12 16
7 14
7 7
6 3
4 1
4 1
0 0
Slide credit: clinicaloptions.com
Hellmann MD, et al. ASCO Abstract Reproduced with permission.

6. CheckMate 032: Pt Characteristics (Randomized Cohort)
Nivolumab
(n = 147)
Nivolumab + Ipilimumab
(n = 95)
Mean age (SD), yrs
≥ 65 yrs, %
63 (29-83) 44
65 (41-91) 51
Male, % 59 63
Prior treatment regimens, % 1
2-3 67 33
Platinum sensitive, % 50 42
Current or former smoker, % 92 95
ECOG PS 0 /1, %
33 / 67
28 / 71
ECOG, Eastern Cooperative Oncology Group; PS, performance status; SD, standard deviation.
Slide credit: clinicaloptions.com
Hellmann MD, et al. ASCO Abstract 8503.

7. CheckMate 032: Efficacy in Randomized and Nonrandomized Pt Cohorts
Outcome
Randomized Cohort
Nonrandomized Cohort
Nivolumab
(n = 147)
Nivolumab + Ipilimumab
(n = 95)
(n = 98)
(n = 61)
ORR, % 12 21 11 23
TTR, mos
1.5
1.4
2.0
3-mo PFS, % 18 30 27 36
3-mo OS, % 65 64 59 72
TTR, time to response.
Responses observed regardless of number of prior lines of therapy, platinum sensitivity or resistance
Slide credit: clinicaloptions.com
Hellmann MD, et al. ASCO Abstract 8503.

8. CheckMate 032: Safety (Pooled Cohorts)
Treatment-Related AE, %
Nivolumab (n = 245)
Nivolumab + Ipilimumab (n = 156)
Any
Grade 3/4 55 12 73 37
Skin 16
<1 36 6
Endocrine 8 21 3
Hepatic 2
Gastrointestinal 5 24
Pulmonary 4
Leading to discontinuation 13 10
Resolution of Gr 3/4 NA 45 78
AE, adverse event; NA, not applicable.
4 treatment-related deaths in combination arm (myasthenia gravis, pneumonitis, seizures/encephalitis, autoimmune hepatitis) vs 1 in nivolumab arm (pneumonitis)
Slide credit: clinicaloptions.com
Hellmann MD, et al. ASCO Abstract 8503.

9. CheckMate 032: Conclusions
Response durability and survival promising with nivolumab ± ipilimumab in extended follow-up of nonrandomized cohort of pts with advanced SCLC
Efficacy of nivolumab ± ipilimumab in randomized cohort of pts with advanced SCLC consistent with prior nonrandomized cohort
Higher incidence of grade 3/4 treatment-related AEs and deaths with combination therapy
Randomized phase III trials ongoing in SCLC
Nivolumab ± ipilimumab as maintenance therapy after initial chemotherapy (CheckMate 451)
Nivolumab alone vs chemotherapy as second line therapy (CheckMate 331)
AE, adverse event; SCLC, small-cell lung cancer.
Slide credit: clinicaloptions.com
Hellmann MD, et al. ASCO Abstract 8503.

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