Nivolumab plus gemcitabine-cisplatin shows benefit for locally advanced mUC

Dr Michiel Van der Heijden - Netherlands Cancer Institute, Amsterdam, Netherlands

The current standard of care, already for decades, in metastatic urothelial cancer is platinum-based chemotherapy and then for those patients who are eligible to receive it it’s cisplatin-based chemotherapy. Now, in recent years maintenance avelumab after chemotherapy has been added to this standard line of therapy, however, this is only for a selected group of patients who still remain in remission directly after their chemotherapy. So there are still big unmet needs for first-line patients, for all first-line patients, to receive better treatments.

In this study what we did is that we randomised patients between cisplatin gemcitabine with or without nivolumab. This study recruited about 600 patients and they were evenly randomised to these two treatments. All patients had previously untreated advanced urothelial cancer. The primary endpoint of the study was overall survival and progression free survival.

The results that we presented here at ESMO are after a median follow-up of 33.6 months. What we found is that, indeed, the study, the CheckMate 901 study, met its primary endpoint of overall survival, significantly improving survival for nivolumab plus gemcitabine over just gemcitabine cisplatin alone. We also met our second primary endpoint which was progression free survival. What was interesting about the responses we saw is that the objective responses were higher in the cisplatin gemcitabine plus nivolumab arm and especially the complete remissions were higher. So they were nearly double in the cisplatin gemcitabine nivolumab arm. Even more interesting was that the duration of these complete remissions was almost three times longer in the cisplatin gemcitabine nivolumab arm than in the cisplatin gemcitabine alone arm. So this suggests that this treatment leads to durable and very deep responses that last quite a long time.