Opdivo (nivolumab)

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

Approval Status:

Approved May 2016

Specific Treatments:

classical Hodgkin lymphoma

Therapeutic Areas

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General Information

Opdivo (nivolumab) targets the cellular pathway known as PD-1/PD-L1, proteins found on the body’s immune cells and some cancer cells. By blocking this pathway, Opdivo may help the body’s immune system fight cancer cells.

Opdivo is specifically indicated for the treatment of patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin.

Opdivo is supplied as a solution for intravenous administration. The recommended dose is 3 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

 

Clinical Results

FDA Approval

The FDA approval of Opdivo for classic Hodgkin's lymphoma was based on two single-arm, multicenter trials of nivolumab in adults with relapsed or refractory cHL. The trials enrolled patients regardless of PD-L1 expression status on Reed-Sternberg cells. The primary efficacy endpoint was objective response rate (ORR) as determined by an independent radiographic review committee.  Additional outcome measures included duration of response (DOR). Efficacy was evaluated in 95 patients previously treated with autologous HSCT and post-transplantation brentuximab vedotin.  Patients had a median of 5 prior systemic regimens and received a median of 17 doses of nivolumab. Single-agent nivolumab produced a 65% ORR, with 58% partial remission and 7% complete remission.  The median time-to-response was 2.1 months.  The estimated median DOR was 8.7 months.

Side Effects

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

  • fatigue
  • upper respiratory tract infection
  • cough
  • pyrexia
  • diarrhea
  • rash
  • pruritus
  • musculoskeletal pain
  • nausea
  • vomiting
  • abdominal pain
  • headache
  • peripheral neuropathy
  • arthralgia
  • dyspnea
  • infusion-related reactions
  • hypothyroidism or thyroiditis

A new “Warning and Precaution” was issued for complications of allogeneic HSCT after nivolumab. Transplant-related deaths have occurred, and health care professionals should follow patients closely for early evidence of transplant-related complications, such as hyperacute graft-versus-host disease (GVHD), severe acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions.

Mechanism of Action

Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. 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.

Additional Information

For additional information regarding Opdivo or Classical Hodgkin's lymphoma, please visit http://www.opdivo.bmscustomerconnect.com/gateway