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Non–Muscle-Invasive Disease: BCG With or Without Novel Vaccine Tested in Phase II Trial

By: Celeste L. Dixon
Posted: Monday, November 1, 2021

In patients with high-grade Bacillus Calmette-Guérin (BCG)-refractory non–muscle-invasive bladder cancer, no significant differences in recurrence-free survival or progression-free survival emerged in a phase II trial comparing further treatment with either an additional course of BCG alone or BCG in combination with a recombinant pox-viral vector vaccine. The results of this trial, conducted by Ragheed Saoud, MD, of Northwell Health on Long Island, New York, and colleagues, were presented during the 2021 American Urological Association (AUA) Annual Meeting (Abstract MP16-04) and published in The Journal of Urology.

The randomized, open-label, prospective study included 15 patients in each arm, with no statistically significant difference in baseline patient characteristics. Of the 30 patients, 10 had had two or more prior induction courses of BCG. Although all 30 patients received intravesical BCG for a total of 6 weeks, the patients in the combination arm also received priming and booster doses of the vaccine. All were followed for 1 year.

The 12-month recurrence-free survival rates and the primary endpoints were 42.9% and 44.4% in the BCG-alone and combination arms, respectively (P = .971). The median time to recurrence was also similar (11.7 vs. 9.9 months; P = .77). The rates of progression-free survival, a secondary endpoint, were 79.6% in the BCG-alone arm and 78.6% in the combination arm.

“Following the trial, nine patients sought radical cystectomy, four after BCG alone and five after BCG and [the vaccine],” reported Dr. Saoud and co-investigators, noting that the surgery is standard of care for patients who fail to respond to BCG. The trial was distinctive, they added, “in that it originated prior to the definition of BCG-unresponsive disease, and at least a third of the patients on this trial were already ‘BCG-unresponsive’ upon enrollment and received more BCG.”

Disclosure: The study authors reported no conflicts of interest.



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