Complete resolution occurred in 77% of patients. Twenty-eight patients (11%) had new-onset peripheral neuropathy and 3 patients had worsening of neuropathy from baseline.
The first tumor assessments were conducted 9 weeks after randomization and continued every 6 weeks thereafter. This includes 4 patients (1.5%) who died from pneumonitis or The most frequent serious adverse reactions reported in ≥2% of patients were Tables 24 and 25 summarize adverse reactions and laboratory abnormalities, respectively, in CHECKMATE-275.The safety of OPDIVO administered as a single agent or in combination with ipilimumab was evaluated in CHECKMATE-142, a multicenter, non-randomized, multiple parallel-cohort, open-label trial [see In the OPDIVO with ipilimumab cohort, serious adverse reactions occurred in 47% of patients.
The incidence of neutralizing antibodies against nivolumab was 0.8% (4/516) with OPDIVO 3 mg/kg followed by ipilimumab 1 mg/kg every 3 weeks, 1.4% (7/491) with OPDIVO 3 mg/kg every 2 weeks and ipilimumab 1 mg every 6 weeks, and 4.6% (18/394) with OPDIVO 1 mg/kg followed by ipilimumab 3 mg/kg every 3 weeks.Of the patients with hepatocellular carcinoma who were treated with OPDIVO and ipilimumab every 3 weeks for 4 doses followed by OPDIVO every 3 weeks and were evaluable for the presence of anti-nivolumab antibodies, the incidence of anti-nivolumab antibodies was 45% (20/44) with OPDIVO 3 mg/kg followed by ipilimumab 1 mg/kg and 56% (27/48) with OPDIVO 1 mg/kg followed by ipilimumab 3 mg/kg; the corresponding incidence of neutralizing antibodies against nivolumab was 14% (6/44) and 23% (11/48), respectively.Of the patients with NSCLC who were treated with OPDIVO 360 mg every 3 weeks in combination with ipilimumab 1 mg/kg every 6 weeks and platinum-doublet chemotherapy, and were evaluable for the presence of anti-nivolumab antibodies, the incidence of anti-nivolumab antibodies was 34% (104/308); the incidence of neutralizing antibodies against nivolumab was 2.6% (8/308).There was no evidence of increased incidence of infusion-related reactions with anti-nivolumab antibody development.The following adverse reactions have been identified during postapproval use of OPDIVO. The majority of patients were White (93%) and male (76%); the majority of patients were enrolled in Europe (57%) with the remainder in US/Canada (32%) and the rest of the world (11%). Pneumonitis resolved in 72% of the patients. Several cohorts enrolled patients with metastatic small cell lung cancer (SCLC), regardless of PD-L1 tumor status, with disease progression after platinum-based chemotherapy to receive OPDIVO 3 mg/kg by intravenous infusion every 2 weeks. No overall difference in safety was reported between elderly patients and younger patients. The majority of patients were male (75%) and White (88%) and 34% and 66% of patients had a baseline KPS of 70% to 80% and 90% to 100%, respectively.
Key eligibility criteria were at least one prior line of treatment for metastatic disease, ECOG performance status 0 or 1, and absence of the following: active brain metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression.Patients enrolled in the single agent OPDIVO MSI-H mCRC cohort received OPDIVO 3 mg/kg by intravenous infusion (IV) every 2 weeks. Complete resolution occurred in 38 patients.Hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (119/547) of patients with RCC and 15% (18/119) of patients with CRC who received OPDIVO 3 mg/kg and ipilimumab 1 mg/kg every 3 weeks. Discard if cloudy, discolored, or contains extraneous particulate matter other than a few translucent-to-white, proteinaceous particles.