Opdivo (nivolumab)

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

Approval Status:

Approved November 2016

Specific Treatments:

recurrent or metastatic squamous cell carcinoma of the head and neck

Therapeutic Areas

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General Information

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

Opdivo is specifically indicated for recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy.

Opdivo is supplied as an intravenous infusion. The recommended dose is 3 mg/kg every two weeks

Clinical Results

FDA Approval

The FDA approval of Opdivo for head and neck cancer was based on the Phase III CheckMate -141 trial. The global open-label, randomized, trial evaluated Opdivo versus investigator’s choice of therapy in patients with recurrent or metastatic SCCHN who had tumor progression during or within six months of receiving platinum-based therapy administered in the adjuvant, neo-adjuvant, primary (unresectable locally advanced) or metastatic setting.Patients were included regardless of their HPV or PD-L1 status.1 Patients were randomized 2:1 to receive Opdivo 3 mg/kg intravenously over 60 minutes every two weeks (n=240), or investigator’s choice (n=121) of: methotrextate 40 to 60 mg/m2 intravenously weekly, docetaxel 30 to 40 mg/m2 intravenously weekly, or cetuximab 400 mg/m2 intravenously once then 250 mg/m2 weekly. Opdivo demonstrated statistically significant and clinically meaningful superior OS vs the comparator arm, with a 30% reduction in the risk of death (p=0.0101]). The median OS was 7.5 months for Opdivo compared to 5.1 months for investigator’s choice.

Side Effects

Adverse effects associated with the use of Opdivo for head and neck cancer 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

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 recurrent or metastatic squamous cell carcinoma of the head and neck, please visit http://www.opdivo.bmscustomerconnect.com/gateway