NIAGARA was an open label phase 3 randomised multicenter trial that randomised patients with MIBC planned for radical cystectomy into Durvalumab arm and standard treatment arm. The Durvalumab arm received 4 cycles of NACT (Gem-Cis) 4 cycles along with Duravlumab (1500mg) followed by RC and subsequently received 8 cycles of adjuvant Durvalumab every 4 weeks whereas the standard treatment arm received NACT followed by RC. A total of 1063 patients were randomised & 75% completed the neo-adj treatment in both the arms. The pathological complete response was seen in 33.8% of the patients in the Durvalumab arm and 25.8% patients in the standard arm. After a median follow-up of 42.3months, the estimated event free survival (progression, recurrence or death) at 24 months was 67.8% vs 59.8% and the overall survival at 24 months was 82.2% vs 75.2% in the Durvalumab arm vs the standard arm. Both the regimes were similarly tolerated and GrIII or IV adverse events were reported in 69.4% in the Durvalumab arm and in 67.5% in the standard treatment arm. Treatment related deaths were noted in 0.6% in each arm and adverse events leading to discontinuation of treatment was seen in 14.9% in Durvalumab arm vs 15.2% in the standard treatment arm. To summarise, peri-operative Durvalumab showed significant oncological advantage in patients undergoing radical cystectomy.
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