Leo Reis MD MSc PhD MBA Fulbright UroScience

It has been nearly 5 months since the FDA approved durvalumab + BCG for “BCG-naïve” high-risk #NMIBC based on the POTOMAC trial. There has been considerable discussion about the discordant results of the recent phase III trials evaluating BCG + immune checkpoint blockade. But I think we're overlooking a potentially important difference between these trials, one that could have major implications for how we interpret the results and counsel our patients. POTOMAC and CREST were positive trials, but unlike the negative ALBAN trial, both permitted enrollment of patients previously treated with BCG. To my knowledge, neither has reported how many patients had prior BCG exposure or whether the benefit of adding checkpoint blockade differs between previously treated and truly BCG-naïve patients. Given the additional toxicity, treatment burden, and cost of systemic checkpoint blockade, how can we adequately counsel patients receiving BCG for the first time without knowing the magnitude of benefit specifically in patients like them? I think we need to see these subgroup data from @AstraZeneca and @pfizer . 1/n @BladderCancerUS ; @BCAN_Research ; @SUO_YUO ; @UroOnc ; @FDA ; @chana_weinstock ; @AmerUrological