EAU 2018: Early Surgical Safety Outcomes from PURE-01: Neoadjuvant Pembrolizumab before Radical Cystectomy For Muscle-Invasive Urothelial Bladder Carcinoma

Copenhagen, Denmark (UroToday.com) Briganti et al. presented a secondary analysis on the early surgical safety outcomes from PURE-01, a phase 2 open-label trial of neoadjuvant Pembrolizumab, an immune checkpoint inhibitor, prior to radical cystectomy for muscle-invasive bladder cancer (MIBC). Pembro is already approved for the treatment of metastatic urothelial carcinoma, and given the benefit of using neoadjuvant chemotherapy for MIBC, there is a great deal of excited anticipation to see how well checkpoint inhibitors may work in this space. Given the toxicity of chemotherapy regimens, using immune-oncologic agents would be a preferred choice, if clinically effective.

According to the study design, patients with MIBC are given 3x3 weekly cycles of pembro, and are then imaged to check for progression or response. Non-responders are given DD-MVAC x 3 to ensure they get effective neoadjuvant therapy, followed by radical cystectomy. Survival data is collected until 2 years post-surgery. Of 25 patients, only 6 developed complications, and only 1 developed a Grade 3-4 complication from pembro treatment. 3 patients developed thyroiditis, which was the most frequent complication.

Overall, early data suggests that the use of pembro in the neoadjuvant setting is safe and tolerated well by these patients. This is some of the first data presenting safety profiles on checkpoint inhibitors in the neoadjuvant setting, so we hope that this safety endures. Of course, unique immunological side effects need longer-term follow up; and more patient data is needed to understand if patients recover differently following major surgery after immunomodulation. Nonetheless, we look forward to the results of this trial as the treatment landscape for bladder cancer continues to grow.

Presented by: Briganti A., Vita Salute San Raffaele University, Dept. of Urology, Milan, Italy

Co-Authors: Necchi A.², Raggi D.², Giannatempo P.², Bianchi M.¹, Freschi M.3, Colecchia M.⁴, Fossati N.¹, Gandaglia G.¹, Salonia A.¹, Salvioni R.⁵, Colombo R.¹, Gallina A.¹, Montorsi F.¹

Author Information:
1. Vita Salute San Raffaele University, Dept. of Urology, Milan, Italy
2. National Cancer Institute, Dept. of Oncology, Milan, Italy
3. IRCCS San Raffaele Hospital, Dept. of Pathology, Milan, Italy
4. National Cancer Institute, Dept. of Pathology, Milan, Italy
5. National Cancer Institute, Dept. of Urology, Milan, Italy

Written by: Shreyas Joshi, MD, Fox Chase Cancer Center, Philadelphia, PA at the 2018 European Association of Urology Meeting EAU18, 16-20 March, 2018 Copenhagen, Denmark

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