MP43-09 PHASE I TRIAL OF INTRAVESICAL BACILLUS CALMETTE-GUéRIN COMBINED WITH INTRAVENOUS PEMBROLIZUMAB IN HIGH GRADE NONMUSCLE INVASIVE BLADDER CANCER. (2019)

You have accessJournal of UrologyBladder Cancer: Non-invasive III (MP43)1 Apr 2019MP43-09 PHASE I TRIAL OF INTRAVESICAL BACILLUS CALMETTE-GUéRIN COMBINED WITH INTRAVENOUS PEMBROLIZUMAB IN HIGH GRADE NONMUSCLE INVASIVE BLADDER CANCER. Shaheen Alanee*, Ahmed El-Zawahry, kevin McVary, Mustafa Deebajah, Sherjeel Sana, Kathy Robinson, and Krishna Rao Shaheen Alanee*Shaheen Alanee* More articles by this author , Ahmed El-ZawahryAhmed El-Zawahry More articles by this author , kevin McVarykevin McVary More articles by this author , Mustafa DeebajahMustafa Deebajah More articles by this author , Sherjeel SanaSherjeel Sana More articles by this author , Kathy RobinsonKathy Robinson More articles by this author , and Krishna RaoKrishna Rao More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000556232.21454.29AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: A phase I trial of intravesical bacillus Calmette-Guerin (BCG) in combination with systemic pembrolizumab was conducted in patients with high grade non-muscle invasive bladder cancer who had persistent or recurrent disease after failing treatment with at least 2 courses of intravesical therapy (one of which had to contain BCG) or BCG followed by maintenance BCG. The primary objective was to determine the safety of this combination. Secondary end points included response to treatment at 19 weeks (end of treatment) and 3 months post treatment. METHODS: A total of 12 patients were consented and 10 patients with recurrent/persistent high-grade non-muscle invasive bladder cancer after at least two courses of intravesical therapy or one course of BCG treatment followed by one course of maintenance BCG received treatment. Six doses of pembrolizumab (100 vs 200 mg) were given every 3 weeks over 16 weeks given concurrently with 6 weekly doses of BCG beginning at week 7. Patient safety was evaluated during and for 30 days following pembrolizumab treatment. Preliminary combination efficacy was determined at 19 weeks using cystoscopy. Bladder biopsy was performed in patients with suspicious lesions. RESULTS: The combination of BCG and pembrolizumab was well tolerated at both 100mg and 200mg fixed doses. Fatigue and dysuria, spasm, urgency, sensitivity, and frequency were the most common adverse events reported. All AE were grade 1 or 2. Two patients died during the trial period. One patient died due to progression of upper urinary tract urethelial carcinoma. The second patient died after cystectomy (for progressive disease) from a cardiovascular event. Of the first 9 patients, 7 (78%) had no evidence of disease in the bladder at 19 weeks, end of treatment. The tenth patient is still in treatment. CONCLUSIONS: The combination of BCG and Pembrolizumab was well tolerated. Intravesical BCG and pembrolizumab may have clinical activity in non-muscle invasive bladder cancer recurring after repeated intravesical therapy. A phase III trial will soon open to test the clinical activity of this combination (KEYNOTE-676). Source of Funding: MERCK & CO Detroit, MI; Springfield, IL; Maywood, IL; Detroit, MI; Springfield, IL© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e620-e621 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Shaheen Alanee* More articles by this author Ahmed El-Zawahry More articles by this author kevin McVary More articles by this author Mustafa Deebajah More articles by this author Sherjeel Sana More articles by this author Kathy Robinson More articles by this author Krishna Rao More articles by this author Expand All Advertisement PDF downloadLoading ...