This year’s ESMO congress was a landmark event for research in urothelial carcinoma. The introduction of two studies that demonstrated effective treatment alternatives to chemotherapy, the standard of care for decades, marks a significant turning point. Prof Christof Vulsteke, a GU oncologist from Maria Middelares Gent, seized the opportunity to converse with Dr Michiel van der Heijden, medical oncologist at the Netherlands Cancer Institute, Amsterdam who presented the outcomes of the CheckMate 901 trial.
Trial Design:
The CheckMate 901 is a phase III trial evaluating the combination of nivolumab plus gemcitabine/cisplatin versus gemcitabine/cisplatin alone for patients with previously untreated unresectable or metastatic urothelial carcinoma. The combination of nivolumab and gemcitabine/cisplatin not only improved overall and progression-free survival, but also significantly increased both objective response and complete response rates. The fact that the complete response rate was nearly doubled with the combination therapy (21.7% versus 11.8%) is particularly noteworthy. Similarly impressive is that the duration of complete response was almost three times longer with the combination therapy (37.1 months versus 13.2 months), despite nivolumab being administered for a maximum of only two years.
Implications for practice:
Prof Vulsteke and Dr van der Heijden also touched upon the impressive results of the EV-302 trial in which both of them participated. It’s going to be hard to point out groups of patients that cannot be treated with enfortumab vedotin and pembrolizumab. Healthcare systems worldwide differ dramatically in how they handle pricing and reimbursement for pharmaceuticals. While EV pembrolizumab may become a more immediate choice for patients in the US due to different structures and regulations, the cost and reimbursement process can limit availability in Europe and other parts of the world. That’s why it’s beneficial to have alternatives like the combination of nivolumab and gemcitabine/cisplatin.
They concluded their interesting discussion with some future insights. The currently ongoing studies that are awaiting approval have chemotherapy as a control arm, so there will be criticism for these trials when they read out in the coming years. Strategic decisions will be necessary regarding the design of future trials, taking into account the evolving landscape of first line treatments. With multiple treatment options and combinations becoming available, it becomes crucial to wisely choose which therapies to use and when.
The final results of CheckMate 901 are concurrently published in The New England Journal of Medicine https://www.nejm.org/doi/pdf/10.1056/NEJMoa2309863
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