IMFINZI (durvalumab) - Limited-stage small cell lung cancer (LS-SCLC)

The clinical benefit of IMFINZI (durvalumab) 50 mg/mL concentrate for solution for infusion is substantial in the MA indication.

Considering:

• evidence of the superiority of durvalumab versus placebo as maintenance therapy following chemoradiation therapy in a randomised, double-blind study in terms of overall survival (OS, primary endpoint) in the ITT population, with an HR = 0.73; 98.32% CI (0.54; 0.98) with a median OS of 55.9 months (95% CI [37.3–NR]) versus 33.4 months (95% CI [25.5–39.9]) in the  placebo group;

and despite:

• uncertainties regarding the robustness of the results for PFS, given the lack of initial significance when assigning a more conservative alpha risk;
• the imprecision of the median survival estimations, linked to data from interim analyses and a median follow-up limited to 30 months;
• the lack of efficacy and safety data beyond 30 months in this indication;
• the absence of any formal conclusion that can be drawn on quality of life (exploratory endpoint);
• non-inclusion of patients with an ECOG score > 1;
• a safety profile marked by the onset of adverse events leading to treatment discontinuation recorded in 12% of patients in the IMFINZI group and 6% in the comparator group, and more frequent immune-mediated adverse events, mainly hypothyroidism (13.7% versus 3.4%) and pneumonitis events (11.8% versus 3%);

the Committee deems that IMFINZI (durvalumab) 50 mg/ml concentrate for solution for infusion provides a minor clinical added value (CAV IV) in the current care pathway for the treatment of adults with limited-stage SCLC whose disease has not progressed following platinum-based chemoradiation therapy.