Neoadjuvant treatment of non-small cell lung cancer

Active Ingredient: Nivolumab

Indication for Nivolumab

Population group: only adults (18 years old or older)
Therapeutic intent: Neo-adjuvant intent

Nivolumab in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥1%.

For this indication, competent medicine agencies globally authorize below treatments:

360 mg of nivolumab once every 3 weeks for 3 cycles

For:

Dosage regimens

Intravenous, 360 milligrams nivolumab, once every 3 weeks. This step is repeated 3 times.

Detailed description

The recommended dose is 360 mg nivolumab administered intravenously over 30 minutes in combination with platinum-based chemotherapy every 3 weeks for 3 cycles.

Duration of treatment

Treatment with nivolumab, either as a monotherapy or in combination with other therapeutic agents, should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient (and up to maximum duration of therapy if specified for an indication).

Atypical responses (i.e., an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed. It is recommended to continue treatment with nivolumab or nivolumab in combination with ipilimumab for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.

Dose escalation or reduction is not recommended for nivolumab as monotherapy or in combination with other therapeutic agents. Dosing delay or discontinuation may be required based on individual safety and tolerability. When nivolumab is administered in combination with other therapeutic agents, refer to the SmPC of these other combination therapeutic agents regarding dosing.

Nivolumab as monotherapy or in combination with other therapeutic agents should be permanently discontinued for:

  • Grade 4 or recurrent Grade 3 adverse reactions;
  • Persistent Grade 2 or 3 adverse reactions despite management.

When nivolumab is administered in combination with chemotherapy, refer to the SmPC of the other combination therapy agents regarding dosing. If any agents are withheld, the other agents may be continued. If dosing is resumed after a delay, either the combination treatment, nivolumab monotherapy or chemotherapy alone could be resumed based on the evaluation of the individual patient.

Dosage considerations

When administered in combination with chemotherapy, nivolumab should be given first followed by chemotherapy on the same day. Use separate infusion bags and filters for each infusion.

Active ingredient

Nivolumab

Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to the programmed death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2. Nivolumab potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands. In syngeneic mouse models, blocking PD-1 activity resulted in decreased tumour growth.

Read more about Nivolumab

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