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In patients with muscle-invasive bladder cancer (MIBC), neoadjuvant durvalumab combined with neoadjuvant cisplatin-based chemotherapy outperformed neoadjuvant chemotherapy alone in the phase 3 NIAGARA trial.

Neoadjuvant chemotherapy followed by radical cystectomy improves overall survival (OS) versus cystectomy alone in patients with MIBC and has been recommended for the past 40 years¹. However, about half of patients experience recurrence within 3 years².

The phase 3 NIAGARA trial (NCT03732677) evaluated the safety and efficacy of perioperative durvalumab combined with neoadjuvant chemotherapy in patients with MIBC. Enrolled were 1,066 (cisplatin-eligible) patients with MIBC were randomly assigned to four cycles of neoadjuvant durvalumab plus gemcitabine/cisplatin or gemcitabine/cisplatin alone, followed by cystectomy. After surgery, participants in the durvalumab/chemotherapy arm received eight cycles of durvalumab while there was no adjuvant treatment for the participants in the neoadjuvant chemotherapy alone arm. Thomas Powles, MD, MBBS, from the Barts Cancer Center, in the UK presented the primary results of NIAGARA³.

After a median follow-up of 42 months, event-free survival (EFS), the first primary endpoint, was significantly improved in the durvalumab arm: median EFS was not reached in the durvalumab arm versus 46.1 months in the chemotherapy alone arm (HR 0.68; 95% CI 0.56–0.82; P<0.0001). EFS rates at 24 months were 67.8% and 59.8%, respectively. OS rate at 24 months was improved in the durvalumab arm: 82.2% versus 75.5% (HR 0.75; 95% CI 0.59–0.93; P=0.0106). The observed EFS and OS benefits with durvalumab were consistent across subgroups. The second primary endpoint, pathological complete response, also favored the durvalumab arm: 37.3% versus 27.5%.

Adding durvalumab to neoadjuvant chemotherapy was tolerable with no new safety signals. Neoadjuvant durvalumab did not delay surgery and did not impact the ability of the participants to undergo and complete surgery.

“NIAGARA supports perioperative durvalumab with neoadjuvant chemotherapy as a potential new standard treatment for patients with cisplatin-eligible MIBC,” concluded Dr. Powles.

Medical writing support was provided by Marten Dooper.
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