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Combining the Nectin-4 antibody-drug conjugate enfortumab vedotin with pembrolizumab nearly doubled survival compared with platinum chemotherapy in advanced urothelial cancer, the biggest advance in this disease in 40 years.
Open-label phase 3 trial of 886 patients with untreated locally advanced or metastatic urothelial carcinoma, eligible for cisplatin or carboplatin, randomised to enfortumab vedotin plus pembrolizumab or gemcitabine plus platinum. Dual primary endpoints were PFS by blinded review and OS.
Median PFS was 12.5 vs 6.3 months (HR 0.45) and median OS 31.5 vs 16.1 months (HR 0.47), with benefit regardless of cisplatin eligibility or PD-L1 expression. It displaced platinum chemotherapy as first-line standard of care, the first regimen to do so since the 1980s, and is the first ADC plus checkpoint inhibitor combination to become a first-line standard in any cancer.
Almost every patient newly diagnosed with advanced bladder or urothelial cancer should now be offered enfortumab vedotin plus pembrolizumab rather than chemotherapy, with median survival extended from about 16 months to over two and a half years. Neuropathy and skin toxicity need monitoring and dose adjustment, and patients with severe diabetes or pre-existing neuropathy need care. Platinum chemotherapy remains an option for those who cannot receive the combination.
Shares Lines of therapy, Objective response rate (ORR), Too many combinations to test, Progression-free survival (PFS).
Shares Enfortumab vedotin, Astellas, Muscle-invasive and advanced bladder cancer, Pfizer (incl. Seagen).
Shares Enfortumab vedotin, Astellas, Muscle-invasive and advanced bladder cancer, Pfizer (incl. Seagen).
Shares Bladder preservation for MIBC after perioperative EV + pembrolizumab complete response, Nectin-4, Enfortumab vedotin, Astellas.
Shares Bladder preservation for MIBC after perioperative EV + pembrolizumab complete response, Enfortumab vedotin, Astellas, Bladder & urothelial cancer.
Shares Enfortumab vedotin, Muscle-invasive and advanced bladder cancer, Merck & Co. (MSD), Bladder & urothelial cancer.
Shares Enfortumab vedotin, Astellas, Muscle-invasive and advanced bladder cancer, Pfizer (incl. Seagen).
Shares Enfortumab vedotin, Muscle-invasive and advanced bladder cancer, Merck & Co. (MSD), Bladder & urothelial cancer.