Astellas article: UK multidisciplinary recommendations on use of combination first-line enfortumab vedotin▼ and pembrolizumab in advanced urothelial carcinoma.

[PRESCRIBING INFORMATION & ADR REPORTING] This is an Astellas article. Prescribing information can be accessed at https://dhgd52pup2eiv.cloudfront.net/23ffe42b-4e89-48e1-b8d8-08b726ed94c1/b5d6cdf5-d05a-4bb1-9965-de9a244d39eb/b5d6cdf5-d05a-4bb1-9965-de9a244d39eb_source__v.pdf and the adverse event reporting information can be found on the last page of that link.

[BACKGROUND] Advanced urothelial carcinoma (UC) significantly impacts quality of life, is associated with poor prognosis, and carries a high economic burden. Recently, the combination of enfortumab vedotin and pembrolizumab (EV-P) has demonstrated improved progression-free survival vs platinum-based chemotherapy and overall survival, and is now recommended as a first-line therapy for patients with unresectable or metastatic disease who are platinum eligible.

[METHODS] A multidisciplinary expert panel was convened to review the current UK patient pathway for advanced UC. The panel developed consensus recommendations for implementing EV-P in the United Kingdom and provided guidance on managing adverse events (AEs), taking into account the challenges in the current pathway.

[RESULTS] The expert panel recommended leveraging lessons from the previous implementation of new immunotherapies and antibody-drug conjugates as EV-P is implemented across the United Kingdom. They emphasized the importance of peer support from clinical centers involved in the EV-302 phase 3 clinical trial, advocating for the sharing of protocols, advice, and support for toxicity management. Recommendations included establishing robust referral pathways and multidisciplinary care models tailored to the resources and structures of different hospital settings. Education in proactive side effect identification and management was recommended for bladder cancer clinical nurse specialists, acute oncology nurses, pharmacists, and clinicians. The panel developed patient checklists to support clinicians in assessing treatment suitability, monitoring AEs during therapy, and ensuring continued monitoring after treatment ends. Detailed recommendations were provided for managing AEs, with a focus on skin reactions, peripheral neuropathy, hyperglycemia, pneumonitis/interstitial lung disease, and ocular disorders, along with guidance on when to involve specialist services.

[CONCLUSION] These consensus recommendations provide practical, multidisciplinary guidance to support the effective implementation of EV-P for advanced UC in UK healthcare settings.