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Opdivo (nivolumab)

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

Approval Status:

Approved February 2017

Specific Treatments:

metastatic urothelial carcinoma

Therapeutic Areas

General Information

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

Opdivo is specifically indicated for patients with locally advanced or metastatic urothelial carcinoma who: • have disease progression during or following platinum-containing chemotherapy • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Opdivo is supplied as an injection for intravenous administration. The recommended dose for patients with locally advanced or metastatic urothelial 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 duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Opdivo was evaluated in CHECKMATE-275, which enrolled 270 patients with locally advanced or metastatic urothelial carcinoma who had disease progression during or following platinum containing chemotherapy or who had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen. Patients received 3 mg/kg of Opdivo by intravenous infusion every 2 weeks until unacceptable toxicity or either radiographic or clinical progression. Tumor response assessments were conducted every 8 weeks for the first 48 weeks and every 12 weeks thereafter. Major efficacy outcome measures included confirmed overall response rate (ORR) as assessed by independent radiographic review committee (IRRC) using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and duration of response (DOR). The confirmed ORR was 19.6%. Responses were observed in both PD-L1 expressors and non-expressors. The confirmed ORR in patients expressing PD-L1 ≥1% was 23.8%  and 16.1% in patients expressing PD-L1 <1%. In patients expressing PD-L1 ≥5%, the confirmed ORR was 28.4% and 15.8% in patients expressing PD-L1 <5%. The median duration of response was not reached in the overall population with a minimum follow-up of six months, and responses were ongoing in 77% of patients.

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.

Additional Information

For additional information regarding Opdivo or metastatic urothelial carcinoma, please visit https://www.opdivo.com/

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