Durvalumab in combination with BCG for BCG-naive, high-risk, non-muscle-invasive bladder cancer (POTOMAC)
thelancet.com/journals/lance…
In patients with BCG-naive, high-risk non-muscle-invasive
#BladderCancer (NMIBC), recurrence and progression after standard transurethral resection of bladder tumor (TURBT) and BCG therapy remain significant challenges.
This phase 3, randomized, open-label trial evaluated whether adding 1 year of durvalumab to BCG therapy could improve outcomes compared with BCG alone. A total of 1,018 patients were randomized to durvalumab plus BCG induction and maintenance, durvalumab plus BCG induction only, or BCG induction and maintenance alone. At a median follow-up of approximately 5⃣ years, the combination of durvalumab with BCG induction and maintenance reduced the risk of disease recurrence or death by 32% compared with BCG alone (hazard ratio 0.68), with a manageable safety profile.
These findings suggest that durvalumab combined with BCG induction and maintenance may offer a new, effective treatment option for patients with high-risk NMIBC.
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