Atezolizumab (3) – Tecentriq®

a) Urothelial carcinoma; patients who are not suitable for treatment with cisplatin and whose tumours have PD-L1 expression ≥ 5 % (first-line)

• Additional benefit is not proven for the treatment of locally advanced or metastatic urothelial carcinoma in adult patients who are not suitable for treatment with cisplatin and whose tumours have PD-L1 expression of ≥ 5%.
• mortality
  • The median overall survival in the single-arm IMvigor210 trial, based on the latest data cut-off (12 July 2017), is 16.3 months, which is marginally longer than the 7.2 to 10 months observed following treatment with gemcitabine and carboplatin, compared with the data available at the time of the initial assessment.
  • In the context of the four head-to-head comparisons of overall survival conducted by the pharmaceutical manufacturer, only the results of two analyses are statistically significantly different for the current data cut-off as well.
• Side effects
  • As previously described in the initial assessment, the data on adverse events are once again incomplete, as no comparative data are available for some adverse events.
• Overall assessment
  • The data submitted by the pharmaceutical manufacturer are not suitable for establishing any additional benefit of atezolizumab compared with the appropriate comparator therapy.
  • On the one hand, the data are incomplete, particularly with regard to adverse events. Due to this incomplete data set, no proper comparison can be made between atezolizumab and the appropriate comparator therapy.
  • Furthermore, the effects reported are not sufficiently large to rule out the possibility that the differences are attributable solely to confounding factors.
  • Statements regarding additional benefit based on a comparison of individual arms from different studies can, due to the high uncertainty of the results, only be made if very large effects are present. However, such effects are not present here for relevant endpoints relating to overall survival, symptoms, health-related quality of life and adverse events.
  • In summary, there are therefore no suitable data available to establish the additional benefit of atezolizumab as monotherapy; this applies in particular to the patient population covered by the current marketing authorisation (patients with tumours exhibiting PD-L1 expression ≥ 5 %). Due to the limited data available, the additional benefit of atezolizumab as monotherapy is therefore not proven for patients who are unsuitable for treatment with cisplatin and whose tumours have PD-L1 expression ≥ 5%.

Courtesy translation only, please refer to the German original.