ONIVYDE PEGYLATED LIPOSOMAL (pegylated liposomal irinotecan) - Metastatic adenocarcinoma of the pancreas

The clinical benefit of ONIVYDE PEGYLATED LIPOSOMAL (pegylated liposomal irinotecan) 4.3 mg/ml concentrate for dispersion for infusion is substantial in the treatment of adult patients with metastatic adenocarcinoma of the pancreas with an ECOG score of 0 or 1.

Considering:

• evidence in a phase 3, comparative, randomised, open-label study of the superiority of ONIVYDE (pegylated liposomal irinotecan) in combination with oxaliplatin, leucovorin and 5-fluorouracil (NALIRIFOX protocol) compared to the gemcitabine/nab-paclitaxel combination for the treatment of patients with metastatic adenocarcinoma of the pancreas, in terms of:
  • overall survival (OS), with a modest difference in median of +1.9 months and an HR = 0.83 (CI95% = [0.70; 0.99]), and an upper bound of the confidence interval very close to 1,
  • progression-free survival, with a difference in median of +1.8 months and an HR = 0.69, (CI95%= [0.58; 0.83];

and despite:

• the absence of comparison of the NALIRIFOX protocol with the FOLFIRINOX protocol, and hence with irinotecan in its standard form,
• the absence of any formal conclusion that can be drawn based on the quality of life results,
• a safety profile marked, in particular, by gastrointestinal disorders, primarily diarrhoea (70.5% all grades and 20% with grade ≥3),

the Committee deems that ONIVYDE PEGYLATED LIPOSOMAL (pegylated liposomal irinotecan) 4.3 mg/ml concentrate for dispersion for infusion provides a minor clinical added value (CAV IV) compared to the gemcitabine/nab-paclitaxel combination.