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A New Therapeutic Option for BCG-Unresponsive Bladder Cancer
Patients with high-grade T1 or carcinoma in situ (CIS) bladder cancer who are unresponsive to treatment with intravesical bacillus Calmette–Guérin (BCG) have limited management options.
Now, investigators have conducted an industry-sponsored, multicenter, three-cohort, open-label trial to determine if intravesical nogapendekin alfa inbakicept (NAI) — an immune-cell–
activating interleukin-15 superagonist — can act synergistically with BCG in patients with BCG-unresponsive, non–muscle-invasive bladder cancer (NMIBC).
Patients in the three cohorts were treated for 6 weeks with the following results:
- Cohort A (84 patients), with BCG-unresponsive CIS with or without Ta/T1 papillary NMIBC, received NAI plus BCG. At median follow-up of 23.9 months, the complete response (CR) rate at 3 or 6 months (the primary endpoint) was 71%.
- Cohort B (77 patients), with BCG-unresponsive high-grade papillary Ta/T1 NMIBC, also received NAI and BCG. At a median follow-up of 20.7 months, disease-free survival at 12 months (the primary endpoint) was 55%.
- Cohort C (10 patients), with BCG-unresponsive CIS with or without Ta/T1 papillary NMIBC, received NAI alone. At median follow-up of 7.9 months, the CR rate at 3 or 6 months (the primary endpoint) was only 20%.
- In cohorts A and B, NAI plus BCG was well-tolerated with typical BCG-associated adverse effects. The most frequent grade 3 events were hematuria (2%) and urinary tract infection (2%). Three grade 3 immune adverse events occurred; 1 patient died from myocardial infarction.
In this preliminary report of an ongoing study, the combination of NAI plus BCG had provocative levels of activity and a very acceptable safety profile in patients with BCG-unresponsive CIS with or without Ta/T1 papillary NMIBC.
Chamie K et al.
Title: IL-15 superagonist NAI in BCG-unresponsive non–muscle-invasive bladder cancer.
Source: NEJM Evidence 2022 Nov 10; [e-pub]. (Abstract/FREE Full Text)