Opdivo (nivolumab)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved August 2018

Specific Treatments:

advanced small cell lung cancer

General Information

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

Opdivo is specifically indicated for patients with metastatic small cell lung cancer with progression after platinum based chemotherapy and at least one other line of therapy.

Opdivo is supplied as an injection for intravenous administration. The recommended dose of Opdivo for patients with metastatic small cell lung cancer is 240 mg administered as an intravenous infusion over 30 minutes every 2 weeks until disease progression or unacceptable toxicity.

Clinical Results

FDA Approvals

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

The FDA approval of Opdivo for small cell lung cancer was based on CHECKMATE-032, multicenter, open-label, multi-cohort trial evaluating nivolumab as a single agent or in combination with ipilimumab in patients with advanced or metastatic solid tumors. 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 treatment with OPDIVO 3 mg/kg by intravenous infusion over 60 minutes every 2 weeks. Tumor assessments were conducted every 6 weeks for the first 24 weeks and every 12 weeks thereafter. The major efficacy outcome measures were ORR and duration of response according to RECIST v1.1 as assessed by Blinded Independent Central Review (BICR). A total of 109 patients with SCLC who progressed after platinum-based chemotherapy and at least one other prior line of therapy were enrolled and received OPDIVO 3 mg/kg IV every two weeks. The overall response rate of the trial was 12% (13 patients). The duration of response was 6 months or longer in 10 of the patients.

Side Effects

Adverse effects associated with the use of Opdivo 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.

Additional Information

For additional information regarding Opdivo or advanced small cell lung cancer, please visit https://www.opdivo.com/advanced-small-cell-lung-cancer