AUA 2022: Two-Year Efficacy Follow-Up of a Phase I Trial of Intravesical BCG Combined with Intravenous Pembrolizumab in Recurrent or Persistent High-Grade NMIBC after Previous BCG Treatment

( The 2022 Annual Meeting of the American Urological Association was host to a moderated poster session for non-invasive bladder cancer. Dr. Jazzmyne Montgomery presented the results of a 2-year efficacy follow-up of a phase I dose-escalation trial of intravesical BCG in combination with systemic pembrolizumab in recurrent and persistent HG NMIBC after previous BCG treatment (NCT02324582). The objective of this study was to evaluate the safety profile and disease-free survival (DFS) and overall survival (OS) efficacy results after a 2-year follow up.


The study cohort included 13 patients (18 screened, 5 failure). Pembrolizumab was administered every 3 weeks (over a 16 week period) concurrently with six weekly doses of BCG beginning starting week 7. Patient safety was evaluated from the time of consent until 30 days after pembrolizumab treatment. Recurrence was evaluated using cystoscopy and cytology with biopsy of suspicious lesions.

Data cutoff for analysis was October 10, 2021. The median patient age was 73.0 years, and 11 patients (84.6%) were male. 92.3% were Caucasian. With regards to initial bladder cancer T stage: 9 (69.2%) were cT1, 3 (23.1%) were pTa and 1 (7.7%) had CIS. Following re-staging TURBT, 6 (46.2%) were pTa, 6 (46.2%) were CIS, and 1 (7.7%) was pT1. DFS and OS at 12 months were 69.3% and 92.31, respectively. At 24 months, the corresponding rates were 38.5% and 92.3%, respectively.




 Dr. Montgomery noted that the safety of combination BCG and IV pembrolizumab has now been established and the preliminary efficacy results are promising. A phase III trial is currently recruiting subjects to test the efficacy of this combination in HGNMIBC (KEYNOTE-676).


Presented by: Jazzmyne Montgomery, MD, MS, Resident Physician, Department of Urology, SIU School of Medicine, Springlfield, IL 

Written by: Rashid Sayyid, MD, MSc – Urology Chief Resident, Augusta University/Medical College of Georgia, @rksayyid on Twitter during the 2022 American Urological Association (AUA) Annual Meeting, New Orleans, LA, Fri, May 13 – Mon, May 16, 2022.