TAGRISSO (osimertinib) - Unresectable non-small cell lung cancer (NSCLC)

The clinical benefit of TAGRISSO 40 mg and 80 mg (osimertinib) is substantial in the MA indication.

Considering:

• the concomitant development of IMFINZI (durvalumab) and TAGRISSO (osimertinib) and the absence of an expected benefit of immunotherapy in these patients, no direct comparison between these two products was expected on the date of this assessment,
• the demonstration of the superiority of TAGRISSO (osimertinib) on progression-free survival compared to placebo, with a median survival of 39.1 months in the osimertinib group versus 5.6 months in the placebo group (HR = 0.16; 95% CI [0.10; 0.24]; p<0.001) in a randomised, double-blind study (LAURA trial), conducted in patients with locally advanced, unresectable (stage IIIA, IIIB, IIIC) NSCLC whose tumours have activating EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations) and whose disease has not progressed during or following platinum-based chemoradiation therapy,
• the lack of evidence of efficacy on overall survival (immature data at the time of the interim analysis), a relevant clinical endpoint in this disease,
• the absence of any formal conclusion that can be drawn on quality of life (exploratory endpoint),
• a safety profile marked by a higher frequency of grade 3-5 adverse events (35% versus 12.3%), serious adverse events (38.5% versus 15.1%) and adverse events leading to treatment discontinuation (12.6% versus 5.5%) or of particular interest (in particular diffuse and radiation-induced interstitial lung disease),

the Committee deems that TAGRISSO 40 mg and 80 mg (osimertinib) provides a minor clinical added value (CAV IV) compared to monitoring alone.