To report urinary bother, urinalysis changes, disease-free survival (DFS), and overall survival (OS) over 2 years for subjects enrolled in a phase I dose-escalation trial (NCT02324582) of intravesical Bacillus Calmette-Guérin (BCG) in combination with systemic pembrolizumab for recurrent or persistent high-grade non-muscle invasive bladder cancer (HGNMIBC).
Eighteen patients consented to the study. Five were screen failures. Clinical activity was determined using cystoscopy and cytology with a biopsy of suspicious lesions. Urinalysis and International Prostate symptom score were assessed at pre-treatment, Week 10 (during combined BCG and pembrolizumab treatment), and 3 and 6 months from treatment completion. IPSS was analyzed using a mixed-model repeated measures analysis. A Chi-square test was used to compare urinalysis results at each interval.
The pathologic disease stage after restaging transurethral resection and before treatment was pTa in 6 (46.2%), CIS in 6 (46.2%), and pT1 in 1 (7.7%). There was no increase in reported urinary bother throughout treatment. Quality of life measurements demonstrated no change in subjective burden. On urinalysis, we did not observe significant differences at 3 months compared to baseline evaluation. At 12 months, the DFS and OS were 69.23% and 92.31%, respectively. At 24 months, the DFS and OS were 38.46% and 92.31%, respectively.
Treatment with BCG combined with intravenous pembrolizumab is not showing increased urinary bother or adverse urinalysis changes. Two-year response data is promising and await confirmation in the phase III study (Keynote 676).
Clinical genitourinary cancer. 2024 Feb 28 [Epub ahead of print]
Jazzmyne Montgomery, Daniel Lybbert, Sherjeel Sana, Ahmed El-Zawahry, James Peabody, Tiffany Pearce, Nicole Adams, Mustafa Deebajah, Danuta Dynda, Kara Babaian, Jane Crabtree, Kristin Delfino, Kevin McVary, Kathy Robinson, Krishna Rao, Shaheen Alanee
Southern Illinois University School of Medicine, Southern Illinois School of Medicine, Springfield, IL., Aurora Healthcare, Milwaukee, WI., Department of Urology, The University of Toledo Medical Center, Toledo, OH., Henry Ford Health System, Detroit, MI., Loyola University Medical Center, Department of Urology, Maywood, IL., Detroit Medical Center, Detroit, MI. Electronic address: .