In adult patients with previously untreated metastatic NSCLC (CheckMate 9LA)^†

OPDIVO, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated
for the treatment of adult patients with metastatic NSCLC with no EGFR or ALK genomic tumor
aberrations, and no prior systemic therapy for metastatic NSCLC.

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In an open-label trial, OPDIVO + YERVOY and platinum-doublet chemotherapy
demonstrated a significant improvement in overall survival^1†

31% reduction in risk of death vs. platinum-doublet chemotherapy alone
(HR: 0.69; 96.71% CI: 0.55, 0.87, p=0.0006)
43.2% (156/361) of patients in the OPDIVO + YERVOY and platinum-doublet
chemotherapy arm experienced an event vs. 54.5% (195/358) of patients
in the platinum-doublet chemotherapy arm

Efficacy results from the pre-specified interim analysis when 351 events
were observed (87% of the planned number of events for the final analysis).

For complete efficacy results and safety profile information, please refer to the OPDIVO Product Monograph.

CI: confidence interval; HR: hazard ratio; NSCLC: non-small cell lung cancer; OS: overall survival; PD-L1: Programmed death-ligand 1

† CheckMate 9LA: A randomized, open-label, phase 3 study of OPDIVO + ipilimumab and platinum-doublet chemotherapy vs. platinum-doublet chemotherapy alone. Patients (N=719)
were randomized 1:1 to receive either OPDIVO 360 mg Q3W + ipilimumab 1 mg/kg Q6W and histology-based platinum-doublet chemotherapy Q3W for 2 cycles (n=361) or histology-based
platinum-doublet chemotherapy Q3W for 4 cycles (n=358) (patients with non-squamous NSCLC could receive optional pemetrexed maintenance therapy). Trial evaluated patients across PD-L1
expression and histology. Patients with known EGFR mutations or ALK translocations sensitive to available targeted inhibitor therapy, untreated brain metastases, carcinomatous meningitis,
active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the study. Treatment continued until disease progression, unacceptable toxicity,
or for up to 2 years. Treatment could continue beyond disease progression if a patient was clinically stable and was considered to be deriving clinical benefit by the investigator. Patients who
discontinued combination therapy because of an adverse event attributed to ipilimumab were permitted to continue OPDIVO as a single agent. Primary endpoint was overall survival.

In previously untreated, unresectable or metastatic melanoma^†

OPDIVO, as monotherapy or in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable
or metastatic melanoma who have not received prior systemic therapy for unresectable or metastatic melanoma.
YERVOY in combination with nivolumab is indicated for the treatment of unresectable or metastatic melanoma in adults
who have not received prior systemic therapy for unresectable or metastatic melanoma.

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your patients more time?

Demonstrated superior OS vs. YERVOY
(primary analysis – 28 months of minimum follow-up)^1†

45% reduction in risk of death for OPDIVO + YERVOY vs. YERVOY alone
(HR: 0.55 [98% CI: 0.42, 0.72; p<0.0001]); number of events: 128/314
(OPDIVO + YERVOY arm) vs. 197/315 (YERVOY arm)
37% reduction in risk of death for OPDIVO alone vs. YERVOY alone (HR: 0.63 [98% CI:
0.48–0.81; p<0.0001]); number of events: 142/316 (OPDIVO arm) vs. 197/315 (YERVOY arm)

For complete efficacy results and safety profile information, please refer to the OPDIVO Product Monograph.

OS: overall survival; CI: confidence interval; HR: hazard ratio. † CheckMate 067: A multicenter, double-blind, randomized trial in patients with unresectable or metastatic melanoma. Patients received OPDIVO + YERVOY (n=314),
OPDIVO as a single agent (n=316), or YERVOY alone (n=315). Patients in the combination arm received OPDIVO 1 mg/kg and YERVOY 3 mg/kg every 3 weeks for the
first 4 doses followed by OPDIVO 3 mg/kg as a single agent every 2 weeks. Patients in the OPDIVO single-agent arm received OPDIVO 3 mg/kg every 2 weeks.
Patients in the comparator arm received YERVOY 3 mg/kg every 3 weeks for 4 doses followed by placebo every 2 weeks. Patients who had not received prior
systemic anticancer therapy for unresectable or metastatic melanoma were enrolled regardless of PD-L1 expression.
‡ Exploratory follow-up conducted for CheckMate 067. The minimum follow-up for patients at the time of this analysis was 5 years.

CheckMate
067 trial results

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Exploratory Analysis

In previously untreated, unresectable or metastatic melanoma^†

OPDIVO, as monotherapy or in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable
or metastatic melanoma who have not received prior systemic therapy for unresectable or metastatic melanoma.¹
YERVOY in combination with nivolumab is indicated for the treatment of unresectable or metastatic melanoma in adults
who have not received prior systemic therapy for unresectable or metastatic melanoma.²

For complete efficacy results and safety profile information, please refer to the OPDIVO Product Monograph.

OS: overall survival; CI: confidence interval; HR: hazard ratio. † CheckMate 067: A multicenter, double-blind, randomized trial in patients with unresectable or metastatic melanoma. Patients received OPDIVO + YERVOY (n=314), OPDIVO as a single agent (n=316), or YERVOY alone (n=315).
Patients in the combination arm received OPDIVO 1 mg/kg and YERVOY 3 mg/kg every 3 weeks for the first 4 doses followed by OPDIVO 3 mg/kg as a single agent every 2 weeks. Patients in the OPDIVO single-agent arm received
OPDIVO 3 mg/kg every 2 weeks. Patients in the comparator arm received YERVOY 3 mg/kg every 3 weeks for 4 doses followed by placebo every 2 weeks. Patients who had not received prior systemic anticancer therapy for
unresectable or metastatic melanoma were enrolled regardless of PD-L1 expression.
‡ Exploratory follow-up conducted for CheckMate 067. The minimum follow-up for patients at the time of this analysis was 5 years.

In intermediate/poor risk patients with previously untreated, advanced RCC

OPDIVO, in combination with YERVOY, is indicated for the treatment of adult patients with
intermediate/poor-risk advanced or metastatic renal cell carcinoma (RCC).

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Demonstrated superior OS vs. sunitinib
(primary analysis – 17.5 months of minimum follow-up)^1†

HR 0.63; 99.8% CI: 0.44, 0.89, p<0.0001^‡
Number of events: 140/425 (OPDIVO + YERVOY arm) vs. 188/422 (sunitinib arm)

The trial did not demonstrate a statistically significant improvement in PFS
(co-primary endpoint): HR=0.82 (99.1% CI: 0.64, 1.05; p=0.0331); median PFS:
11.6 months (OPDIVO + YERVOY arm) vs. 8.4 (sunitinib arm)

For complete efficacy results and safety profile information, please refer to the OPDIVO Product Monograph.

OS: overall survival; CI: confidence interval; HR: hazard ratio; PFS: progression-free survival. † CheckMate 214: A randomized (1:1), open-label study in patients with previously untreated advanced or metastatic RCC. Patients were stratified by International
Metastatic RCC Database Consortium (IMDC) prognostic score and region. The primary efficacy population included intermediate/poor risk patients with
at least 1 or more of 6 prognostic risk factors as per the IMDC criteria. Patients were randomized to OPDIVO 3 mg/kg + YERVOY 1 mg/kg (n=425) administered
intravenously every 3 weeks for 4 doses followed by OPDIVO monotherapy 3 mg/kg every two weeks (n=425) or to sunitinib (n=422) administered orally
50 mg daily for 4 weeks followed by 2 weeks off, every cycle. OS was assessed by an independent radiologic review committee.
‡ Exploratory follow-up conducted for CheckMate 214. The minimum follow-up for patients at the time of this analysis was 41.4 months.

CheckMate
214 trial results

Learn more

Exploratory Analysis

In intermediate/poor risk patients with previously untreated, advanced RCC

OPDIVO, in combination with YERVOY, is indicated for the treatment of adult patients with intermediate/poor-risk advanced or metastatic renal cell carcinoma (RCC).

For complete efficacy results and safety profile information, please refer to the OPDIVO Product Monograph.

HR: hazard ratio; OS: overall survival. † CheckMate 214: A randomized (1:1), open-label study in patients with previously untreated advanced or metastatic RCC. Patients were stratified by International Metastatic RCC Database Consortium (IMDC) prognostic score and region.
The primary efficacy population included intermediate/poor risk patients with at least 1 or more of 6 prognostic risk factors as per the IMDC criteria. Patients were randomized to OPDIVO 3 mg/kg + YERVOY 1 mg/kg (n=425) administered
intravenously every 3 weeks for 4 doses followed by OPDIVO monotherapy 3 mg/kg every two weeks (n=425) or to sunitinib (n=422) administered orally 50 mg daily for 4 weeks followed by 2 weeks off, every cycle. OS was assessed by
an independent radiologic review committee.
‡ Exploratory follow-up conducted for CheckMate 214. The minimum follow-up for patients at the time of this analysis was 41.4 months.

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