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 0 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 |
7 15 |
2.3 0 |
0 0 |
Nervous system Peripheral neuropathy§ |
13 |
6 |
0 |
0 |
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*
- 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.
Treatment Modifications
See recommended dosing modifications for immune-mediated adverse reactions.
Dosing Schedules
Find dosing information to get patients started on therapy.
More NSCLC Indications
See selected safety profiles for other non-small cell lung cancer indications.
References:
- OPDIVO [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
- 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.