Neoadjuvant NSCLC

Selected safety profile

INDICATION OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

CHECKMATE 816: FOR PATIENTS WITH RESECTABLE NSCLC, REGARDLESS OF PD-L1 EXPRESSION

Neoadjuvant OPDIVO® + chemo safety profile1

ADVERSE REACTIONS IN >10% OF PATIENTS RECEIVING OPDIVO + CHEMO*
ADVERSE REACTIONS OPDIVO + CHEMO
(n=176)
CHEMO (n=176) OPDIVO + CHEMO
(n=176)
CHEMO (n=176)
ALL GRADES (%) ALL GRADES (%) GRADES 3-4 (%) GRADES 3-4 (%)
Gastrointestinal 
Nausea 
Constipation 
Vomiting

38 
34 
11

45 
32 
13

0.6 

1.1

1.1 
1.1 
0.6
General 
Fatigue 
Malaise

26 
15

23 
14

2.3 
0.6

1.1 
0.6
Metabolism and nutrition 
Decreased appetite

20

23

1.1

2.3
Skin and subcutaneous tissue 
Rash 
Alopecia

20 
11


15

2.3 
0


0
Nervous system 
Peripheral neuropathy§

13

6

0

0
  • The most common (>20%) adverse reactions were nausea (38%), constipation (34%), fatigue (26%), decreased appetite (20%), and rash (20%)1
  • Serious adverse reactions occurred in 30% of patients1
    • Serious adverse reactions in >2% of patients included pneumonia and vomiting1
  • 10% of patients discontinued therapy due to adverse reactions1
  • 30% of patients had at least one treatment withheld for an adverse reaction1
  • Adverse reaction data are from the primary analysis. At the 68.4-month median follow-up, no new safety signals were observed1,2

*Toxicity was graded per NCI CTCAE v4.1
Includes fatigue and asthenia.1
Includes rash, dermatitis, acneiform dermatitis, atopic dermatitis, bullous dermatitis, drug eruption, maculopapular rash, and pruritic rash.1
§Includes peripheral neuropathy, dysesthesia, hypoesthesia, peripheral motor neuropathy, peripheral sensory neuropathy.1

NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.

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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 NSCLC Indications

See selected safety profiles for other non-small cell lung cancer indications.

References:

  1. OPDIVO [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
  2. Forde PM, Spicer JD, Provencio M, et al. Overall survival with neoadjuvant nivolumab plus chemotherapy in lung cancer. N Engl J Med. 2025 Jun 2. doi:10.1056/NEJMoa2502931.


466-US-2500115 06/25