About the CheckMate 901 Trial of Frontline Nivolumab Plus Chemo in mUC

Michiel S. Van der Heijden, MD, PhD, Netherlands Cancer Institute, Amsterdam, the Netherlands, discusses background of the phase 3 CheckMate 901 study (NCT03036098) which evaluated concurrent frontline nivolumab (Opdivo) and gemcitabine/cisplatin followed by nivolumab maintenance therapy among patients with previously untreated, metastatic or unresectable urothelial carcinoma.

Findings from the study demonstrated overall survival (OS) and progression-free survival (PFS) benefits with the nivolumab regimen vs gemcitabine/cisplatin alone in this patient population.

In this video, Van der Heijden discusses what led to the start of this phase 3 study.

Transcription:

0:09 | Metastatic urothelial cancer has been treated for decades with chemotherapy for the whole generation [we have] known no different treatment than that. In recent years, immunotherapy has been added to the treatment landscape, first as a second-line and then as maintenance after chemotherapy, but only for those patients who had a disease control after 4 to 6 cycles of chemotherapy. There was only a subset of patients, so an important need was still there for patients to improve the treatment in the first-line.

0:45 | Now for bladder cancer, the chemotherapy that is used is platinum-based chemotherapy, which has 2 options: cisplatin or carboplatin. Cisplatin is the more active one. In previous studies, trying to combine chemotherapy and immunotherapy, investigators used both options mixed into the control group. And in those studies, we already saw that patients who had a combination of cisplatin chemotherapy with immunotherapy seem to do better on the combination and patients who received carboplatin because as the studies were not designed to make a difference, the studies were negative. But it is already indicated that that combination might actually do much better. So sort of in the study, CheckMate 901. We randomized patients with advanced urothelial cancer who never had treatment before for advanced disease to either regular cisplatin/gemcitabine or cisplatin/gemcitabine together with nivolumab, followed by nivolumab monotherapy.