2022 Top Story in Bladder Cancer: Use of N-803 With BCG in BCG-Unresponsive Non–Muscle Invasive Bladder Cancer
The final results from an open-label multicenter study (NCT03022825) examining the use of N-803 with BCG in patients with BCG-unresponsive non–muscle invasive bladder cancer were presented at ASCO in June and published in the Journal of Clinical Oncology.1
N-803, an IL-15 super agonist that activates natural killer cells and CD8+ T cells, was combined with BCG and tested in patients in two cohorts: group A (carcinoma in situ [CIS]) and group B (papillary disease).
A total of 160 patients (83 with CIS and 77 with papillary disease) were enrolled, and the median number of prior BCG doses was 12. Patients received intravesical N-803 with BCG using standard induction and maintenance dosing.
The authors reported results for each cohort. Among patients with CIS, 71% (59/83) had a complete response, with a median duration of 24 months in responders. There was a 96% 2-year bladder cancer–specific progression-free survival in muscle-invasive bladder cancer. For patients with papillary disease, 12-month and 24-month disease-free survival rates of 57% and 48% were noted. At 2 years of follow-up, a total of 90% had avoided cystectomy.
Treatment was well-tolerated. Low-grade treatment-related adverse events were reported, including dysuria (22%) and urgency (12%), and there were no grade 4 or 5 adverse events. No immune-related serious adverse events occurred.
In summary, for patients with BCG-unresponsive disease, N-803 plus BCG offers a safe, effective, and well-tolerated treatment option.
This study is significant because treating BCG-unresponsive disease is challenging and patients have limited options. Also, many patients may not be eligible for or wish to undergo cystectomy. This important study offers a new option that can provide a durable treatment alternative for patients with a life-threatening bladder cancer diagnosis.
Bullish
