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General Information

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody.

Opdivo is specifically indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Opdivo is supplied as an injection for intravenous administration. The recommended dose of Opdivo for hepatocellular carcinoma is either: • 240 mg every 2 weeks or • 480 mg every 4 weeks administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.

Clinical Results

FDA Approval

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Opdivo was evaluated in a 154-patient subgroup of CHECKMATE-040, a multicenter, open-label trial conducted in patients with hepatocellular carcinoma (HCC) who progressed on or were intolerant to sorafenib. Patients received 3 mg/kg of Opdivo by intravenous infusion every 2 weeks. Tumor assessments were conducted every 6 weeks for 48 weeks and every 12 weeks thereafter. The major efficacy outcome measure was confirmed overall response rate, as assessed by blinded independent central review using RECIST v1.1 and modified RECIST (mRECIST) for HCC. Duration of response was also assessed. Following Opdivo treatment, 22 (14.3%) of the 154 patients had a confirmed ORR; three patients had a complete response and 19 patients had a partial response. Of the 22 people who saw a response, 91% had a response that lasted 6 months or longer and 55% had a response that lasted 12 months or longer.

Side Effects

Adverse effects associated with the use of Opdivo as a single agent may include, but are not limited to, the following:

fatigue

rash

musculoskeletal pain

pruritus

diarrhea

nausea

asthenia

cough

dyspnea

constipation

decreased appetite

back pain

arthralgia

upper respiratory tract infection

pyrexia

headache

abdominal pain

Mechanism of Action

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody. Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.