In adults with cHL who have relapsed or progressed after auto-HSCT
OPDIVO® Select Safety Profile1
- Among all patients (safety population [n=266]):
- OPDIVO was discontinued due to adverse reactions in 7% of patients
- Dose delay for an adverse reaction occurred in 34% of patients
- Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in at least 1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last nivolumab dose, 2 from infection 8 to 9 months after completing nivolumab, and 6 from complications relating to allogeneic HSCT
- The most common adverse reactions (reported in ≥20%) among all patients were upper respiratory tract infection, fatigue, cough, diarrhea, pyrexia, musculoskeletal pain, rash, nausea, and pruritus
- Pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO (one Grade 3 and 12 Grade 2). The median time to onset was 4.5 months (range: 5 days to 12 months). All 13 patients received systemic corticosteroids, with resolution in 12. Four patients permanently discontinued OPDIVO due to pneumonitis. Eight patients continued OPDIVO (three after dose delay), of whom two had recurrence of pneumonitis
- Treatment-emergent peripheral neuropathy was reported in 14% (31/266) of all patients receiving OPDIVO. Twenty-eight patients (11%) had new-onset peripheral neuropathy, and 3 of 40 patients had worsening of neuropathy from baseline. These adverse reactions were Grade 1 or 2, except for 1 Grade 3 event (<1%). The median time to onset was 50 (range: 1 to 309) days
- Please refer to the Important Safety Information for complications of allogeneic HSCT after OPDIVO
Auto-HSCT=autologous hematopoietic stem cell transplantation.
Non-Laboratory Adverse Reactions Occurring in ≥10% of Patients With cHL (Checkmate 205 and Checkmate 039)*
|Respiratory, Thoracic, and Mediastinal Disorders|
|Skin and Subcutaneous Tissue Disorders|
|Musculoskeletal and Connective Tissue Disorders|
|Nervous System Disorders|
|Injury, Poisoning, and Procedural Complications|
*Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.
†Includes events occurring up to 30 days after last nivolumab dose, regardless of causality. After an immune-mediated adverse reaction, reactions following nivolumab rechallenge were included if they occurred up to 30 days after completing the initial nivolumab course.
||Includes abdominal discomfort and upper abdominal pain.
¶Includes nasopharyngitis, pharyngitis, rhinitis, and sinusitis.
#Includes pneumonia bacterial, pneumonia mycoplasmal, pneumocystis jirovecii pneumonia.
**Includes dermatitis, dermatitis acneiform, dermatitis exfoliative, and rash described as macular, papular, maculopapular, pruritic, exfoliative, or acneiform.
††Includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, myalgia, neck pain, and pain in extremity.
‡‡Includes hyperesthesia, hypoesthesia, paresthesia, dysesthesia, peripheral motor neuropathy, peripheral
sensory neuropathy, and polyneuropathy. These numbers are specific to treatment-emergent events.