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The CheckMate 901 trial investigated a new combination of the drugs and compared it to treatment with only chemotherapy.
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New Approach to Using Immunotherapy Combinations in Bladder Cancer

Nivolumab and gemcitabine–cisplatin combo showed significantly better outcomes than standard-of-care in patients with advanced urothelial carcinoma

Netherlands Cancer Institute
Published:Nov 17, 2023
|2 min read
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Traditionally, cisplatin-based chemotherapy has been the standard treatment for bladder cancer patients who can tolerate it. However, responses have been limited, and durable outcomes, rare. Over the past years, two Phase 3 clinical trials studied the effects of combining immunotherapy with either chemotherapy or a new drug, enfortumab vedotin, to treat bladder cancer (urothelial carcinoma). With success, both studies show a significant increase in both overall survival as well as progression-free survival.

Medical oncologist Michiel van der Heijden, MD, PhD, from the Netherlands Cancer Institute (NKI) explains: “These results mark a milestone in bladder cancer research, providing the first evidence of a survival benefit of combination therapy involving immune checkpoint inhibitors over chemotherapy. This is an exciting development in our field, as these findings will thoroughly change the treatment landscape for advanced bladder cancer. It is a testament to the collaborative efforts of researchers, and most importantly, the resilience of all patients who participated in this study."

Combining therapies

The CheckMate 901 trial investigated a new combination of the drugs nivolumab and gemcitabine–cisplatin and compared this to treatment with only chemotherapy. The results demonstrated that patients treated with both drugs showed a 22 percent reduction in the risk of death compared to patients only treated with chemotherapy. 

The findings also showed that the combination of nivolumab and chemotherapy led to a significant improvement in progression-free survival vs chemotherapy alone. The results were published in The New England Journal of Medicine

The results of another Phase 3 in the same treatment line will be presented at the European Society for Medical Oncology (ESMO) presidential session, featuring a novel combination of an antibody–drug conjugate with immune checkpoint inhibition, using enfortumab vedotin–pembrolizumab. This study found a statistically significant and clinically meaningful improvement in overall survival and progression-free survival as well. 

In the US, the enfortumab vedotin–pembrolizumab conjugate is already available for a subgroup of bladder cancer patients, based on a Phase 2 study.

- This press release was originally published on the Netherlands Cancer Institute website