Perioperative durvalumab combined with neoadjuvant chemotherapy improves survival in bladder cancer

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 years [1]. However, about half of patients experience recurrence within 3 years [2].

The international, open-label phase 3 NIAGARA trial (NCT03732677) evaluated the safety and efficacy of peri-operative durvalumab combined with neoadjuvant chemotherapy in patients with MIBC. Enrolled were 1,066 (cisplatin-eligible) MIBC participants who were randomised 1:1 to 4 cycles of neoadjuvant durvalumab plus gemcitabine/cisplatin or gemcitabine/cisplatin alone, followed by cystectomy. After surgery, participants in the durvalumab/chemotherapy arm received 8 cycles of durvalumab while there was no adjuvant treatment for the participants in the neoadjuvant chemotherapy alone arm. Prof. Thomas Powles (University of London; Barts Cancer Center, UK) presented the primary results of NIAGARA [3].

After a median follow-up of 42 months, the first primary endpoint of event-free survival (EFS) 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 also 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 favoured 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 Prof. Powles.

1. Holzbeierlein J, et al. J Urol 2024;212:3-10.
2. Pfister C, et al. J Clin Oncol. 2022;40:2013-2022.
3. Powles TB, et al. A randomized phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). Abstract LBA5, ESMO Congress 2024, 13–17 September, Barcelona, Spain.

 

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Posted on 4 November 20244 November 2024