1L Metastatic Gastric, GEJ, or EAC and 1L Metastatic ESCC

Selected safety profile

OPDIVO® (nivolumab) logo with Gastroesophageal icon

INDICATION OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1%).

INDICATION OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1%).

Safety data for OPDIVO + chemotherapy in the 1L metastatic setting

CHECKMATE 648: IN THE 1L TREATMENT OF ADULT PATIENTS EXPRESSING PD-L1 CPS ≥1 WITH METASTATIC ESOPHAGEAL SQUAMOUS CELL CARCINOMA

The chance for durable survival with a well known safety profile

ADVERSE REACTIONS IN ≥10% OF PATIENTS RECEIVING OPDIVO AND CHEMOTHERAPY1

ADVERSE REACTIONS OPDIVO + Cisplatin and 5-FU
(n=310)
Cisplatin and 5-FU
(n=304)
OPDIVO + Cisplatin and 5-FU
(n=310)
Cisplatin and 5-FU
(n=304)
GRADES 1-4 (%) GRADES 1-4 (%) GRADES 3-4 (%) GRADES 3-4 (%)
Gastrointestinal 
Nausea 
Constipation 
Stomatitis* 
Diarrhea 
Vomiting 
Dysphagia 
Abdominal pain
 
65
44
44
29
23
14
13
 
56
43
35
20
19
12
11
 
4.2
1.0
9
2.9
2.3
7
1.9
 
2.6
1.0
3.0
2.0
3.0
4.9
0.7
Metabolism and nutrition 
Decreased appetite
 
51
 
50
 
7
 
6
General
Fatigue
Pyrexia§
Edema||

47
19
16

41
12
13

3.5
0.3
0

4.9
0.3
0
Nervous system 
Peripheral neuropathy

18

13

1.3

1.0
Psychiatric
Insomnia

16

10

0

0.3
Skin and subcutaneous tissue 
Rash# 
Pruritus 
Alopecia
 
16
11
10
 
7
3.6
11
 
0.6
0
0
 
0
0
0
Respiratory, thoracic and mediastinal 
Cough**
 
 16
 
 13
 
 0.3
 
 0.3
Infections and infestations 
Pneumonia††
 
13
 
10
 
5
 
2.6
Endocrine 
Hypothyroidism
 
7
 
0.3
 
0
 
0
Investigations 
Weight decreased
 
12
 
11
 
0.6
 
1.0
Musculoskeletal and
connective tissue 

Musculoskeletal pain‡‡
 
 
11
 
 
8
 
 
0.3
 
 
0.3


Adverse reaction data is from the primary analysis in the ITT population.

Toxicity was graded per NCI CTCAE v4.1
*Includes aphthous ulcer, mouth ulceration, and mucosal inflammation.1
Includes abdominal discomfort, abdominal pain lower, and abdominal pain upper.1
Includes asthenia and malaise.1
§
Includes tumor associated fever.1
||
Includes swelling, generalized edema, edema peripheral, and peripheral swelling.1
Includes hyperaesthesia, hypoaesthesia, peripheral motor neuropathy, peripheral sensorimotor neuropathy, and peripheral sensory neuropathy.1
#
Includes dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis bullous, drug eruption, exfoliative rash, rash erythematous, rash follicular, rash macular, rash maculopapular, rash papular, and rash pruritic.1
**Includes productive cough.1
††
Includes organizing pneumonia, pneumonia bacterial, and pneumonia pseudomonal.1
‡‡
Includes back pain, bone pain, musculoskeletal chest pain, myalgia, neck pain, pain in extremity, and spinal pain.1

1L=first-line; 5-FU=5-fluorouracil; CPS=combined positive score; EAC=esophageal adenocarcinoma; GEJ=gastroesophageal junction; ITT=intention to treat; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events; PD-L1=programmed death-ligand 1.

Among patients who received OPDIVO + chemotherapy:

  • Fatal adverse reactions occurred in 5 (1.6%) patients who received OPDIVO in combination with chemotherapy; these included pneumonitis, pneumatosis intestinal, pneumonia, and acute kidney injury1
  • Serious adverse reactions occurred in 62% of patients receiving OPDIVO in combination with chemotherapy1
  • OPDIVO and/or chemotherapy were discontinued in 39% of patients and were delayed in 71% of patients for an adverse reaction1
  • The most frequent serious adverse reactions reported in ≥2% of patients who received OPDIVO with chemotherapy were pneumonia (11%), dysphagia (7%), esophageal stenosis (2.9%), acute kidney injury (2.9%), and pyrexia (2.3%)1
  • The most common adverse reactions reported in ≥20% of patients treated with OPDIVO in combination with chemotherapy were nausea (65%), decreased appetite (51%), fatigue (47%), constipation (44%), stomatitis (44%), diarrhea (29%), and vomiting (23%)1
Bar graph with magnifying glass icon

Learn about OPDIVO (nivolumab) + ipilimumab as another option in the treatment of 1L metastatic ESCC

Laboratory values worsening from baseline* occurring in ≥10% of patients on OPDIVO, cisplatin, and 5-FU1

LABORATORY ABNORMALITY OPDIVO + Cisplatin and 5-FU
(n=310)
Cisplatin and 5-FU
(n=304)
OPDIVO + Cisplatin and 5-FU
(n=310)
Cisplatin and 5-FU
(n=304)
GRADES 1-4 (%) GRADES 1-4 (%) GRADES 3-4 (%) GRADES 3-4 (%)
Hematology
Anemia
Lymphopenia
Neutropenia
Leukopenia
Thrombocytopenia
 
81
67
61
53
43
 
66
44
48
39
29
 
21
23
18
11
3.3
 
14
8
13 
5
2.8
Chemistry
Hyponatremia
Hypocalcemia
Increased creatinine
Hypomagnesemia
Hyperglycemia
Hyperkalemia
Hypokalemia
Increased alkaline phosphatase
Increased AST
Increased ALT
Hypoglycemia
Hypercalcemia

52
43
41
35
34
33
29
26
23
23
18
11

40
23
31
25
36
24
17
15
11
8
7
8

15
3.0
2.3
1.7
0
2.3
9
1.3
3.3
2.3
0.4
2.6

8
0.7
0.7
1.8
0.8
0.7
6
0
1.4
0.7
0
0

*Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: OPDIVO with cisplatin and 5-FU group (range: 60 to 305 patients) or cisplatin and 5-FU group (range: 56 to 283 patients).1

ALT=alanine aminotransferase; AST=aspartate aminotransferase.

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Treatment Modifications

See recommended dosing modifications for immune-mediated adverse reactions.

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Dosing Schedules

Find dosing information to get patients started on therapy. 

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More Gastroesophageal Indications

Learn more about other gastroesophageal indications across adjuvant and 1L metastatic settings.

Reference:

  1. OPDIVO [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.


1506-US-2400772 05/25

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