Atezolizumab (2) – Tecentriq®

a) Patients who are not suitable for cisplatin-based therapy (first-line treatment)

• An additional benefit is not proven for the first-line treatment of locally advanced or metastatic urothelial carcinoma in patients for whom cisplatin-based chemotherapy is not suitable.
• mortality
  • Results on overall survival are available from only four studies; the results for median overall survival in the single-arm IMvigor210 study, at 15.9 months, compared with results for treatment with gemcitabine and carboplatin ranging from 7.2 to 10 months, are not of a magnitude at which it can be ruled out with sufficient certainty that a difference is not attributable solely to systematic bias.
  • Of the four individual comparisons of overall survival conducted by the pharmaceutical manufacturer, only the results of two analyses show a statistically significant difference.
• Side effects
  • Adverse events were also reported for the benefit assessment dossier, both in terms of relevant overall rates and in terms of specific chemotherapy- and immunotherapy-associated events.
  • Results on adverse events were reported only selectively or were not adequately operationalised and are therefore incomplete. For instance, the comparative studies included provide no data on the overall rates of adverse events (severe AE with CTCAE grade ≥ 3, SAE). Results on therapy discontinuations due to adverse events are available only from IMvigor210 and two comparative studies.
  • With regard to specific AEs, in the absence of further data from the comparative studies, only those AEs that were recorded in at least one of the studies included in the comparison were compared. Inevitably, this comparison is therefore focused on chemotherapy-associated side effects, as all the studies included in the comparison investigated chemotherapy regimens.
• Overall assessment
  • Overall, in first-line treatment of patients who are not suitable for cisplatin-based therapy, an additional benefit of atezolizumab is not proven due to the limited data available. There are no usable results available that could not have arisen solely as a result of systematic bias.
  • For this reason, the information on specific AEs is not sufficient to provide a comprehensive overview of the harm associated with atezolizumab; consequently, individual significant advantages regarding specific AEs are, on the whole, insufficient to demonstrate an additional benefit of atezolizumab in first-line treatment for patients unsuitable for cisplatin-ineligible patients.

b) Patients who have previously received platinum-based therapy

• The pharmaceutical manufacturer does not present any results in the dossier from directly comparative studies or studies suitable for an adjusted indirect comparison for this population.

Courtesy translation only, please refer to the German original.