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Global guidelines, including from ESMO, EAU, and National Comprehensive Cancer Network® (NCCN®), have been restructured to preferentially recommend enfortumab vedotin + pembrolizumab in the 1L setting, regardless of platinum-eligibility status.2-4
Adapted from Powles 2024.2
*At time of publication, this was only approved by the FDA and not approved by the EMA.2
†ESMO-MCBS v1.1 was used to calculate scores for new therapies/indications approved by the EMA or FDA. The scores have been calculated and validated by the ESMO-MCBS Working Group and reviewed by the authors (https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-evaluation-forms).2
‡Enfortumab vedotin (PADCEV) + pembrolizumab is preferred over platinum-based chemotherapy irrespective of platinum eligibility.2
Enfortumab vedotin (PADCEV) + pembrolizumab [I, A; MCBS 4] is the new standard of care and is recommended as the preferred first-line therapy for advanced or metastatic UC.
The combination of enfortumab vedotin (PADCEV) + pembrolizumab is the preferred first-line systemic therapy option for patients with advanced or metastatic urothelial carcinoma, regardless of whether or not they are eligible for cisplatin. Based on high-level data from the EV-302 trial, this regimen has been given a NCCN Category 1 designation by the panel.
The combination of enfortumab vedotin (PADCEV) + pembrolizumab represents the standard of care for patients who are deemed fit for combination therapies, demonstrating significant survival benefit as compared to chemotherapy.
1L – first-line; 2L – second-line; EAU – European Association of Urology; ESMO – European Society for Medical Oncology; MoA – mechanism of action; NCCN – National Comprehensive Cancer Network; SoC – standard of care; UC – urothelial cancer
References
PADCEV, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.
PADCEV as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor.