Durvalumab (9) – Imfinzi®

• Clinical trials
  • The AEGEAN trial is an ongoing, double-blind, randomised Phase IIItrial in which durvalumab in combination with platinum-based chemotherapy for neoadjuvant treatment, followed by durvalumab as monotherapy for adjuvant treatment (intervention arm), was compared with placebo in combination with platinum-based chemotherapy for neoadjuvant treatment, followed by placebo after surgery (control arm).
  • The KEYNOTE 671 trial is an ongoing, double-blind, randomised Phase IIItrial in which pembrolizumab in combination with platinum-based chemotherapy for neoadjuvant treatment, followed by pembrolizumab as monotherapy for adjuvant treatment (intervention arm), was compared with placebo in combination with platinum-based chemotherapy for neoadjuvant treatment, followed by placebo after surgery (comparison arm).

Adults with resectable NSCLC at high risk of recurrence and without EGFR mutations or ALK translocations; neoadjuvant and adjuvant therapy

• An additional benefit is not proven.
• In the absence of direct comparative studies, the pharmaceutical manufacturer relies on an adjusted indirect comparison based on the procedure developed by Bucher et al. to demonstrate additional benefit.
• Consequently, the adjusted indirect comparison submitted is assessed as generally unsuitable for drawing conclusions regarding additional benefit.
• Consequently, taken as a whole, there are no data available that would allow an assessment of additional benefit.
• Conclusion
  • With regard to the similarity between the AEGEAN and KEYNOTE 671 studies, and the patient population used for the adjusted indirect comparison, significant uncertainties remain concerning the proportion of patients with an EGFR mutation or ALK translocation.
  • The results of the adjusted indirect comparison set out in the pharmaceutical manufacturer’s dossier show no statistically significant differences in the endpoints of overall survival, event-free survival and adverse events.
  • Consequently, the adjusted indirect comparison submitted is, on the whole, assessed as unsuitable for drawing conclusions regarding additional benefit. The pharmaceutical manufacturer itself does not infer any additional benefit from these results.

Courtesy translation only, please refer to the German original.