The FDA has approved Durvalumab (Imfinzi) plus BCG for adults with BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC). The approval is based on the phase 3 POTOMAC trial, which compared durvalumab plus BCG against standard BCG therapy alone.
The combination significantly improved disease-free survival, reducing the risk of recurrence or progression by 32% (HR 0.68; P = .0154). Disease-free survival rates at 36 months were 82% with durvalumab plus BCG versus 77% with BCG alone. Median disease-free and overall survival were not reached after more than 65 months of follow-up.
However, adding durvalumab only during BCG induction did not improve outcomes.
Side effects were more common with the combination therapy, including higher rates of serious and grade 3/4 adverse events. Common adverse effects included dysuria, hematuria, arthralgia, hypothyroidism, and rash.