ADVERSE REACTIONS | OPDIVO + FOLFOX or CapeOx (n=782) |
FOLFOX or CapeOx (n=767) |
OPDIVO + FOLFOX or CapeOx (n=782) |
FOLFOX or CapeOx (n=767) |
---|---|---|---|---|
ALL GRADES (%) | ALL GRADES (%) | GRADES 3-4 (%) | GRADES 3-4 (%) | |
Adverse reactions | 99 | 98 | 69 | 59 |
Nervous system Peripheral neuropathy* Headache |
53 11 |
46 6 |
7 0.8 |
4.8 0.3 |
Gastrointestinal Nausea Diarrhea Vomiting Abdominal pain† Constipation Stomatitis‡ |
48 39 31 27 25 17 |
44 34 29 24 21 13 |
3.2 5 4.2 2.8 0.6 1.8 |
3.7 3.7 4.2 2.6 0.4 0.8 |
General Fatigue§ Pyrexia|| Edema¶ |
44 19 12 |
40 11 8 |
7 1.0 0.5 |
5 0.4 0.1 |
Metabolism and nutrition Decreased appetite Hypoalbuminemia# |
29 14 |
26 9 |
3.6 0.3 |
2.5 0.3 |
Investigations Weight decreased Increased lipase Increased amylase |
17 14 12 |
15 8 5 |
1.3 7 3.1 |
0.7 3.7 0.4 |
Musculoskeletal and connective tissue Musculoskeletal pain** |
20 |
14 |
1.3 |
2.0 |
Skin and subcutaneous tissue Rash†† Palmar-plantar erythrodysesthesia syndrome |
18 13 |
4.4 12 |
1.7 1.5 |
0.1 0.8 |
Respiratory, thoracic and mediastinal Cough‡‡ |
13 |
9 |
0.1 |
0 |
Infections and infestations Upper respiratory tract infection§§ |
10 |
7 |
0.1 |
0.1 |
1L Metastatic Gastric, GEJ, or EAC and 1L Metastatic ESCC
Selected safety profile
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
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.
Treatment Modifications
See recommended dosing modifications for immune-mediated adverse reactions.
Dosing Schedules
Find dosing information to get patients started on therapy.
More Gastroesophageal Indications
Learn more about other gastroesophageal indications across adjuvant and 1L metastatic settings.
Reference:
- OPDIVO [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.