Rose TL, Harrison MR, Deal AM, et al. - Among patients with clinical T2-4aN0/XM0 muscle-invasive bladder cancer who were eligible for radical cystectomy (RC), neoadjuvant gemcitabine and cisplatin plus pembrolizumab met its primary endpoint for improved pathologic downstaging and was generally safe.

• Enrolled were 39 patients (72% cT2, 23% cT3, and 5% cT4a).

• Lead-in pembrolizumab 200 mg was provided once 2 weeks to the initial six patients prior to pembrolizumab 200 mg once on day 1, cisplatin 70 mg/m² once on day 1, and gemcitabine 1,000 mg/m² once on days 1 and 8 every 21 days for four cycles.

• Because of toxicity, this schedule was discontinued and subsequent patients were provided cisplatin 35 mg/m² once on days 1 and 8 without lead-in pembrolizumab.

• In 22 patients (56% [95% CI, 40 to 72]), < pT2N0 was achieved and in 14 patients (36% [95% CI, 21 to 53]), pT0N0 was achieved.

• Thrombocytopenia (74%), anemia (69%), neutropenia (67%), and hypomagnesemia (67%) were the most commonly reported adverse events (AEs).