Posted: Tuesday, November 14, 2023
According to the results of the phase III CheckMate 901 trial, presented at the European Society for Medical Oncology (ESMO) Congress 2023 (Abstract LBA7), patients with previously untreated unresectable or metastatic urothelial carcinoma may benefit from the chemoimmunotherapy combination of nivolumab and gemcitabine/cisplatin. This therapeutic strategy significantly improved overall and progression-free survival in this patient population, thus suggesting it may prove to be a new standard-of-care approach, according to Michiel S. Van der Heijden, MD, PhD, of the Netherlands Cancer Institute, Amsterdam, and colleagues.
A total of 608 patients with previously untreated unresectable or metastatic urothelial carcinoma were recruited for the study. They were randomly assigned to receive treatment with nivolumab plus gemcitabine/cisplatin (n = 304) or gemcitabine/cisplatin alone (n = 304). Patients were stratified based on their expression of PD-L1 and the extent of liver metastasis. Clinical outcomes were monitored regularly by blinded independent central review.
The study authors reported an increased median overall survival for patients treated with nivolumab plus gemcitabine/cisplatin (21.7 months) compared with gemcitabine/cisplatin alone (18.9 months, hazard ratio [HR] = 0.78). Similarly, patients treated with nivolumab plus gemcitabine/cisplatin (7.9 months) had an improved overall median progression-free survival compared with patients treated with gemcitabine/cisplatin alone (7.6 months, HR = 0.72). Moreover, overall response (57.6%) and complete response (21.7%) rates were increased with nivolumab plus gemcitabine/cisplatin. Furthermore, 61.8% and 51.7% of patients treated with nivolumab plus gemcitabine/cisplatin and gemcitabine/cisplatin alone reported treatment-related adverse events.
Disclosure: For full disclosures of the study authors, visit cslide.ctimeetingtech.com.