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Full Indication

In the adjuvant treatment of patients with
UC at high-risk of recurrence after radical resection

Select Important Safety Information

In Checkmate 274, serious adverse reactions occurred in 30% of patients receiving OPDIVO (n=351). The most frequent serious adverse reaction reported in ≥2% of patients receiving OPDIVO was urinary tract infection. Fatal adverse reactions occurred in 1% of patients; these included events of pneumonitis (0.6%).

In Checkmate 274, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=351) were rash (36%), fatigue (36%), diarrhea (30%), pruritus (30%), musculoskeletal pain (28%), and urinary tract infection (22%).

Please see additional Important Safety Information below and U.S. Full Prescribing Information for OPDIVO.
PD-L1=programmed death-ligand 1; UC=urothelial carcinoma.

Click or tap the tabs to view additional data.

In the adjuvant treatment of patients with UC at high risk of recurrence after radical resection

Checkmate 274: The first and only phase 3, placebo-controlled adjuvant trial in patients with UC1,2,5

Checkmate 274 Study Design
Checkmate 274 Study Design
  • *Urothelial carcinoma originating in the bladder or upper urinary tract (renal pelvis or ureter).1
  • AJCC tumor stage.6
  • Using the PD-L 1 IHC 28-8 pharmDx assay.1
  • §Approved dosing for OPDIVO is 240 mg IV q2w or 480 mg IV q4w.1
  • OS data are immature at the time of the planned interim analysis.1
  • DFS=disease-free survival; ECOG=Eastern Cooperative Oncology Group; IHC=immunohistochemistry; IV=intravenous;
  • NUTRFS=non-urothelial tract recurrence-free survival; OS=overall survival; PS=performance status; q2w=every 2 weeks: q4w=every 4 weeks.
  • This trial excluded patients with any condition requiring systemic treatment with immunosuppressants (eg, glucocorticoids) within 2 weeks of treatment7
  • DFS was defined as time to first recurrence (local urothelial tract, local non-urothelial tract, or distant metastasis), or death2
  • Minimum follow-up time in all randomized patients was 5.9 months. Median follow-up time in all randomized patients was 20.9 months for OPDIVO and 19.5 months for placebo1

Checkmate 274 baseline characteristics5

  OPDIVO
(n=353)
Placebo
(n=356)
Median age (range), year 65.3 (30‑92) 65.9 (42‑88)
Male, % 75.1 77.2
Region, %    
United States 13.9 14.9
Europe 48.2 48.0
Asia 22.7 20.8
Rest of the world 15.3 16.3
ECOG PS, %    
0 63.5 62.1
1 34.6 35.1
2# 2.0 2.5
Tumor origin at initial diagnosis, %    
Urinary
bladder
79.0 78.9
Upper tract
disease
21.0 21.1
Minor histological variants present,% 41.1 39.6
PD-L1
positivity ≥1% (IVRS)
39.7 39.9
Prior neoadjuvant cisplatin, % 43.3 43.5
Pathologic T stage at resection,**†† %    
pT0-2 22.7 24.2
pT3 58.4 57.3
pT4a 16.1 17.4
Other 2.5 0.8
Nodal status at resection,†† %    
N+ 47.3 47.2
N0/X with <10 nodes removed 26.6 27.8
N0 with ≥10 nodes removed 25.8 24.7
  OPDIVO
(n=353)
Placebo
(n=356)
Median age (range), year 65.3 (30‑92) 65.9 (42‑88)
Male, % 75.1 77.2
Region, %    
United States 13.9 14.9
Europe 48.2 48.0
Asia 22.7 20.8
Rest of the world 15.3 16.3
ECOG PS, %    
0 63.5 62.1
1 34.6 35.1
2# 2.0 2.5
Tumor origin at initial diagnosis, %    
Urinary
bladder
79.0 78.9
Upper tract
disease
21.0 21.1
Minor histological variants present, % 41.1 39.6
PD-L1
positivity ≥1% (IVRS), %
39.7 39.9
Prior neoadjuvant cisplatin, % 43.3 43.5
Pathologic T stage at resection,**†† %    
pT0-2 22.7 24.2
pT3 58.4 57.3
pT4a 16.1 17.4
Other 2.5 0.8
Nodal status at resection,†† %    
N+ 47.3 47.2
N0/X with <10 nodes removed 26.6 27.8
N0 with ≥10 nodes removed 25.8 24.7
  • Not reported for 1 patient in the placebo arm.5
  • #ECOG PS of 2 was permitted only for patents who did not receive cisplatin-based neoadjuvant chemotherapy and were ineligible for adjuvant cisplatin-based chemotherapy.5
  • **The AJCC tumor staging included patients with N+, NO, or NX.5,6
  • ††Not reported for 1 patient in each arm.5
  • IVRS=lnteractive Voice Response System.
In the OPDIVO arm:
  • ~ 40% of patients expressed PD-L1 ≥1%5
  • ~ 43% of patients received prior neoadjuvant chemotherapy5
  • ~ 47% of patients had nodal involvement5

In the adjuvant treatment of patients with UC at high risk of recurrence after radical resection

Nearly double median DFS with OPDIV01,2‡‡

Disease-free survival in all randomized patients1,2
Median Disease-Free Survival With Adjuvant OPDIVO® (nivolumab)
Median Disease-Free Survival With Adjuvant OPDIVO® (nivolumab)
‡‡Vs placebo.1,2
HR=hazard ratio; NE=not estimable; NR=not reached.

Minimum follow-up time of 5.9 months. Median follow-up time of 20.9 months for OPDIVO and 19.5 months for placebo.2

mDFS in patients with PD-L1 ≥1% (minimum follow-up time of 6.3 months; median follow-up time of 22.1 months for OPDIVO and 18.7 months for placebo)1,8

  • OPDIVO (n=140): NR (95% CI: 21.2-NE)1
  • Placebo (n=142): 8.4 months (95% CI: 5.6-21.2)1
  • HR=0.55 (95% CI: 0.39-0.77); P=0.00051

In the adjuvant treatment of patients with UC at high risk of recurrence after radical resection

What are your safety expectations for OPDIVO in the adjuvant setting?

Adjuvant OPDIVO® Selected Safety Profile in UC
Events, %

Adverse reactions occurring in
≥10% of patients receiving OPDIVO1
OPDIVO
(n=351)
Placebo
(n=348)
Any grade (%) Any grade (%)
Any-cause AEs2 98.9 95.4
Rash|||| 36 19
Fatigue/asthenia 36 32
Pruritus 30 16
Diarrhea|||| 30 27
Musculoskeletal pain|||| 28 24
Urinary tract infection|||| 22 23
Renal disorder|||| 17 16
Nausea 16 13
Upper respiratory tract infection|||| 16 16
Abdominal pain|||| 15 15
Cough|||| 14 11
Constipation 13 15
Decreased appetite 13 7
Hepatitis|||| 11 8
Dyspnea|||| 11 6
Arthralgia 11 13
Dizziness|||| 11 9
Hyperthyroidism 11 1.1
Hypothyroidism 11 2.3
Pyrexia 10 10
Events, %

Adverse reactions occurring in
≥10% of patients receiving OPDIVO1
OPDIVO
(n=351)
Placebo
(n=348)
Grade
≥3§§ (%)
Grade
≥3 (%)
Any-cause AEs2 42.7 36.8
Rash|||| 1.7 0.3
Fatigue/asthenia 1.1 0.3
Pruritus 0 0
Diarrhea|||| 2.8 1.7
Musculoskeletal pain|||| 0.6 0.9
Urinary tract infection|||| 6 9
Renal disorder|||| 1.7 0.9
Nausea 0.6 0
Upper respiratory tract infection|||| 0.3 0.6
Abdominal pain|||| 0.9 0.6
Cough|||| 0 0
Constipation 0.3 0.3
Decreased appetite 0.9 0.3
Hepatitis|||| 4 0.6
Dyspneallll 0.3 0.3
Arthralgia 0.3 0
Dizziness|||| 0.3 0
Hyperthyroidism 0 0
Hypothyroidism 0 0
Pyrexia 0.3 0.3
  • Toxicity was graded per NCI CTCAE v4.1
  • §§Fatal adverse reactions occurred in 1% of patients; these included events of pneumonitis (0.6%).1
  • IIIIFor additional information about these adverse reactions, see Full Prescribing Information.
  • AE=adverse event; IMAR=immune-mediated adverse reaction; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.
Grade ≥3 AEs occurred in 42.7% of patients receiving OPDIVO
and in 36.8% of patients receiving placebo2
  • OPDIVO was discontinued for adverse reactions in 18% of patients. OPDIVO was delayed for adverse reactions in 33.3% of patients1,9
  • Placebo was discontinued for adverse reactions in 6% of patients. Placebo was delayed for adverse reactions in 25.9% of patients9
  • Serious adverse reactions occurred in 30% of patients1
  • The most frequent serious adverse reaction reported in ≥2% of patients was urinary tract infection. Fatal adverse reactions occurred in 1% of patients; these included events of pneumonitis (0.6%)1
  • The most common adverse reactions (reported in ≥20% of patients) were fatigue, pruritus, diarrhea, rash, musculoskeletal pain, and urinary tract infection1

Laboratory abnormalities worsening from baseline¶¶ occurring in ≥10% of patients1

Laboratory
abnormality
OPDIVO
(n=351)
Placebo
(n=348)
All Grades (%) Grades
3-4 (%)
All Grades (%) Grades
3-4 (%)
Chemistry        
Increased
creatinine
36 1.7 36 2.6
Increased
amylase
34 8 23 3.2
Increased
lipase
33 12 31 10
Hyperkalemia 32 5 30 6
Increased
alkaline
phosphatase
24 2.3 15 0.6
Increased AST 24 3.5 16 0.9
Increased ALT 23 2.9 15 0.6
Hyponatremia 22 4.1 17 1.8
Hypocalcemia 17 1.2 11 0.9
Hypomagnesemia Hypo-
magnesemia
16 0 9 0
Hypercalcemia 12 0.3 8 0.3
Hematology        
Lymphopenia 33 2.9 27 1.5
Anemia 30 1.4 28 0.9
Neutropenia 11 0.6 10 0.3
Laboratory
abnormality
OPDIVO
(n=351)
Placebo
(n=348)
All Grades 1-4 (%) All Grades 1-4 (%)
Chemistry    
Increased
creatinine
36 36
Increased
amylase
34 23
Increased
lipase
33 31
Hyperkalemia 32 30
Increased
alkaline
phosphatase
24 15
Increased AST 24 16
Increased ALT 23 15
Hyponatremia 22 17
Hypocalcemia 17 11
Hypomagnesemia Hypo-
magnesemia
16 9
Hypercalcemia 12 8
Hematology    
Lymphopenia 33 27
Anemia 30 28
Neutropenia 11 10
Laboratory
abnormality
OPDIVO
(n=351)
Placebo
(n=348)
Grades
3-4 (%)
Grades
3-4 (%)
Chemistry    
Increased
creatinine
1.7 2.6
Increased
amylase
8 3.2
Increased
lipase
12 10
Hyperkalemia 5 6
Increased
alkaline
phosphatase
2.3 0.6
Increased AST 3.5 0.9
Increased ALT 2.9 0.6
Hyponatremia 4.1 1.8
Hypocalcemia 1.2 0.9
Hypomagnesemia Hypo-
magnesemia
0 0
Hypercalcemia 0.3 0.3
Hematology    
Lymphopenia 2.9 1.5
Anemia 1.4 0.9
Neutropenia 0.6 0.3
  • ¶¶Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: OPDIVO group (range: 322 to 348 patients) and placebo group (range: 312 to 341 patients).1
  • ALT=alanine aminotransferase: AST=aspartate aminotransferase.

OPDIVO dosing in the adjuvant treatment of UC1,2

Dosing Options for Adjuvant OPDIVO® (nivolumab)
Dosing Options for Adjuvant OPDIVO® (nivolumab)
  • Based on exploratory dose exposure-response relationships for efficacy and safety, OPDIVO 240 mg q2w and 480 mg q4w are predicted to be similar10
  • Review the Full Prescribing Information for OPDIVO prior to initiation, including recommended dosage and dose modifications
  • No premedication required1
##OPDIVO is administered as an IV infusion over 30 minutes.1

The OPDIVO Safety Tool is a quick reference to the immune-mediated adverse reactions (IMARs) associated with OPDIVO treatment. You may access this web app from your phone, tablet, or computer.


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IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

  • Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions.
  • Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO. Early identification and management are essential to ensure safe use of OPDIVO. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment with OPDIVO. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
  • Withhold or permanently discontinue OPDIVO depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

Immune-Mediated Pneumonitis

  • OPDIVO can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%).

Immune-Mediated Colitis

  • OPDIVO can cause immune-mediated colitis. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%).

Immune-Mediated Hepatitis and Hepatotoxicity

  • OPDIVO can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%).

Immune-Mediated Endocrinopathies

  • OPDIVO can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.
  • In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%).
  • In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%).
  • In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0.6% (12/1994) of patients, including Grade 2 (0.2%).
  • In patients receiving OPDIVO monotherapy, hyperthyroidism occurred in 2.7% (54/1994) of patients, including Grade 3 (<0.1%) and Grade 2 (1.2%).
  • In patients receiving OPDIVO monotherapy, hypothyroidism occurred in 8% (163/1994) of patients, including Grade 3 (0.2%) and Grade 2 (4.8%).
  • In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients, including Grade 3 (0.4%) and Grade 2 (0.3%), and 2 cases of diabetic ketoacidosis.

Immune-Mediated Nephritis with Renal Dysfunction

  • OPDIVO can cause immune-mediated nephritis. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.5%), and Grade 2 (0.6%).

Immune-Mediated Dermatologic Adverse Reactions

  • OPDIVO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes.
  • Withhold or permanently discontinue OPDIVO depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).
  • In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients, including Grade 3 (1.1%) and Grade 2 (2.2%).

Other Immune-Mediated Adverse Reactions

  • The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received OPDIVO monotherapy or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions: cardiac/vascular: myocarditis, pericarditis, vasculitis; nervous system: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; ocular: uveitis, iritis, and other ocular inflammatory toxicities can occur; gastrointestinal: pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis; musculoskeletal and connective tissue: myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica; endocrine: hypoparathyroidism; other (hematologic/immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.
  • Some ocular IMAR cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, which has been observed in patients receiving OPDIVO, as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss.

Infusion-Related Reactions

  • OPDIVO can cause severe infusion-related reactions. Discontinue OPDIVO in patients with severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild (Grade 1) or moderate (Grade 2) infusion-related reactions. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate trial in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation

  • Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with OPDIVO. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between OPDIVO and allogeneic HSCT.
  • Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with OPDIVO prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

  • Based on its mechanism of action and findings from animal studies, OPDIVO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and for at least 5 months after the last dose.

Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone

  • In randomized clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Lactation

  • There are no data on the presence of OPDIVO in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 5 months after the last dose.

Serious Adverse Reactions

  • In Checkmate 274, serious adverse reactions occurred in 30% of patients receiving OPDIVO (n=351). The most frequent serious adverse reaction reported in ≥2% of patients receiving OPDIVO was urinary tract infection. Fatal adverse reactions occurred in 1% of patients; these included events of pneumonitis (0.6%).

Common Adverse Reactions

  • In Checkmate 274, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=351) were rash (36%), fatigue (36%), diarrhea (30%), pruritus (30%), musculoskeletal pain (28%), and urinary tract infection (22%).

Please see US Full Prescribing Information for OPDIVO.

References:

  1. OPDIVO [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
  2. Bajorin DF, Witjes JA, Gschwend JE, et al. Adjuvant nivolumab versus placebo in muscle-invasive urothelial carcinoma. N Engl J Med. 2021;384(22):2102-2114.
  3. Jodon G, Fischer S, Kessler ER. Treatment of urothelial cancer in elderly patients: focus on immune checkpoint inhibitors. Drugs Aging. 2018;35(5):409-421.
  4. Duplisea JJ, Dinney CPN. Should chemotherapy still be used to treat all muscle invasive bladder cancer in the “era of immunotherapy”? Expert Rev Anticancer Ther. 2019;19(7):543-545.
  5. Bajorin DF, Witjes JA, Gschwend JE, et al. First results from the phase 3 CheckMate 274 trial of adjuvant nivolumaba versus placebo in patients who underwent radical surgery for high-risk muscle-invasive urothelial carcinoma. Oral presentation at ASCO GU 2021. Abstract 391.
  6. American Cancer Society. Bladder cancer early detection, diagnosis, and staging. Accessed February 24, 2021. https://www.cancer.org/content/dam/CRC/
    PDF/Public/8559.00.pdf.
  7. Bajorin DF, Witjes JA, Gschwend JE, et al. Adjuvant nivolumab versus placebo in muscle-invasive urothelial carcinoma. N Engl J Med. 2021;384(22):2102-2114 [supplementary appendix].
  8. Data on file. NIVO 639. Princeton, NJ: Bristol-Myers Squibb Company; 2021.
  9. Data on file. NIVO 652. Princeton, NJ: Bristol-Myers Squibb Company; 2021.
  10. Long GV, Tykodi SS, Schneider JG, et al. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018;29(11):2208-2213.