CheckMate 901: Analyzing Complete Responders to Nivolumab Plus Gemcitabine, Cisplatin

A study from Matt D. Galsky, MD, and colleagues presented at the 2024 American Society of Clinical Oncology Annual Meeting evaluated the data of patients who achieved complete response (CR) while participating in the CheckMate 901 study and those with lymph node (LN)-only metastatic urothelial carcinoma (mUC).

The phase 3 CheckMate 901 trial assigned patients with mUC to receive either nivolumab plus gemcitabine and cisplatin or gemcitabine plus cisplatin alone. Trial data showed that patients who received the combination therapy experienced improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR). Those with previously untreated unresectable or mUC demonstrated deep, durable CR.

Dr. Galsky and colleagues created a post hoc analysis reviewing the data of 102 (16.8%) patients in the CheckMate 901 trial who reached a CR.

Researchers found that of the randomized patients, 54 who received nivolumab plus gemcitabine and cisplatin and 56 who received gemcitabine plus cisplatin demonstrated LN-only mUC. The ORR was 81.5% for the nivolumab plus gemcitabine and cisplatin cohort and 64.3% the gemcitabine plus cisplatin cohort. The CR rate was 63.0% and 33.9%, respectively.

In LN-only patients, the OS was 46.3 months for the nivolumab plus gemcitabine and cisplatin arm and 24.9 months for the gemcitabine plus cisplatin arm. Median PFS was 30.5 months and 8.8 months, respectively.

“Nivolumab plus gemcitabine and cisplatin generated deep responses in CheckMate 901 with a fixed duration of chemotherapy and up to 2 years of nivolumab,” the researchers wrote. “Exploratory characterization of patients with CR identified a group of patients enriched with LN-only disease. In patients with LN-only mUC, nivolumab plus gemcitabine and cisplatin induced durable disease control and clinically meaningful improvements in OS and PFS versus gemcitabine alone. These results provide additional support for nivolumab plus cisplatin-based chemotherapy as a first-line treatment option for patients with mUC.”