Sam S. Chang, MD, MBA, discusses the methods and design of the QUILT 3032 study.
Sam S. Chang, MD, MBA, professor Department of Urology, Patricia and Rodes Hart Professor of Urologic Surgery, and chief surgical officer and chief of the Division of Urologic Oncology at Vanderbilt Ingram Cancer Center, discusses the methods and design of the QUILT 3032 study (NCT03022825).
The trial examined the combination of N-803 plus Bacillus Calmette–Guérin (BCG) as treatment in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). There were 160 patients with BCG-unresponsive NMIBC enrolled in the 2 cohorts of the trial.
Patients with carcinoma in situ that may or may not have papillary disease were enrolled in the first tumors while the second cohort consisted of those with papillary disease and T1 disease. Findings of the trial showed improved efficacy and safety, and the combination exceeded what has previously been observed with currently available intravesical and systemic options.
There were 2 cohorts, 1 group that had this carcinoma in situ that may or may not had papillary disease with it. The second cohort was papillary disease [and] T1 disease. The reason why there was a difference was the FDA is focused on these carcinoma in situ patients, [and this] group patients was just under 100, and [it was] just under 100 [patients] in cohorts as well. These patients all received the combination medication, and it was once a week for 6 weeks. Then, there were evaluations to see if the tumor had been eradicated, a complete response for the CIS.
In the papillary group to make sure that disease did not come back, a disease-free period that was measured over time. If these patients responded, they also got a maintenance regimen. What they did was get treatments at 3 and 6 months, and then 6 months in different intervals. As long as they responded, they received maintenance as well. That was the setup for the trial. It was an intravesical therapy once a week for 6 weeks with maintenance, and evaluations with cystoscopy and urine tests.