11 september, 2017
Mature results from the KEYNOTE-045 trial to be presented at the ESMO 2017 Congress in Madrid have confirmed significantly longer survival in patients with advanced urothelial cancer who receive the checkpoint inhibitor pembrolizumab after initial chemotherapy, compared to an alternative chemotherapy regimen.
The new data back up interim figures published earlier this year (2) and are “striking in the setting of urothelial cancer, which is highly lethal in the metastatic state,” said study investigator Dr Ronald de Wit, from Erasmus University Medical Center in Rotterdam, the Netherlands.
“Pembrolizumab is the first agent to improve survival over chemotherapy in the second-line setting. Not all patients benefit from checkpoint inhibition, but a sizeable proportion of patients who respond have very durable responses, even well over one year,” noted de Wit.
SEE: Poster KEYNOTE-045
Mature results from KEYNOTE-045 confirm pembrolizumab significantly improves overall survival versus chemotherapy
The PD-L1 inhibitor pembrolizumab continued to demonstrate a survival benefit compared to chemotherapy among patients with advanced urothelial carcinoma, according to mature findings from the KEYNOTE-045 study presented during the ESMO 2017, the Annual Congress of the European Society for Medical Oncology in Madrid, Spain.
Furthermore, no new safety signals for pembrolizumab were raised with long-term follow-up.
Ronald de Wit, Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, Netherlands, and an international team of researchers conducted the phase III, multicentre, open label KEYNOTE-045 trial (NCT02256436) of pembrolizumab compared to investigators’ choice of chemotherapy, including paclitaxel, docetaxel, or vinflunine in patients with recurrent, advanced urothelial carcinoma.
Previously reported results from this study demonstrated that overall survival (OS) was significantly improved with pembrolizumab.
At ESMO 2017, mature results from KEYNOTE-045 were presented. The study randomly assigned 270 patients with recurrent, advanced urothelial carcinoma to pembrolizumab at 200 mg every 3 weeks and 272 were assigned to investigators’ choice of chemotherapy. The patients’ baseline characteristics were balanced between arms.