Clinical Data in the Adjuvant Setting

To date, no results of adjuvant ICI treatment have been published. Four Phase III trials in patients with completely resected stage IB–IIIA with or without adjuvant chemo- therapy are under way. In KEYNOTE 91, patients were randomised to receive pembrolizumab or placebo for a year (NCT02504372). In the BR31-trial, patients were randomised to receive either durvalumab or matching pla- cebo for a year (NCT02273375). In the IMPower 010 trial, atezolizumab or placebo is administered every 3 weeks for

a maximum of 16 cycles. Finally, the ANVIL trial ran- domises patients to either nivolumab or matching placebo for 1 year (NCT02595944).

Primary endpoint of all trials is disease-free survival. Due to the expected long median, results will not be avail- able soon. None of the trials will solve the question of whether ICI should be given concomitant with adjuvant chemotherapy or might replace it.