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Nivolumab (Opdivo°) as adjuvant treatment for certain oesophageal cancers

 Marketing Authorisations  No proven increase in survival, as of mid-2022, in a double-blind randomised placebo-controlled trial in 794 patients. Longer time before relapse, but with adverse effects that are sometimes serious.
Full article (1 page) available for download by subscribers.

  • Nivolumab is an "immunostimulant" that has already been authorised in the European Union for use in various cancers. It has now also been authorised as adjuvant treatment for patients with oesophageal or gastro-oesophageal junction cancer who have residual disease despite neoadjuvant chemoradiotherapy and surgery.
     
  • The clinical evaluation data on nivolumab in this situation were mainly obtained in a double-blind randomised placebo-controlled trial conducted in 794 patients treated for up to one year.
     
  • At a time when half of the patients had been followed up for at least 24 months, 29% had died. There are no details on how these deaths were distributed between the two groups.

EDITORS' OPINION
Insist upon it
The European Medicines Agency (EMA) published its public assessment report on nivolumab (Opdivo°) as adjuvant therapy for certain oesophageal cancers, without providing the comparative mortality data from the main clinical trial submitted by the drug company. It reported the mortality for all patients, but without specifying the mortality in each group, i.e. deaths in the nivolumab-treated group versus deaths in the placebo group. The EMA argued that these results were unavailable at the time of its assessment, on the pretext that the data were “immature”, i.e. incomplete, due to insufficient follow-up. (...)

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©Prescrire 1 December 2022

Source: "Nivolumab (Opdivo°) as adjuvant treatment for certain oesophageal cancers" Prescrire International 2022; 31 (243): 290. Subscribers only.

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