Pembrolizumab Before Radical Cystectomy: Safe and Effective in Urothelial Carcinoma

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One instance of grade 3 alanine aminotransferase elevation and 5 instances of reversible immune-related adverse events were observed.
One instance of grade 3 alanine aminotransferase elevation and 5 instances of reversible immune-related adverse events were observed.
The following article features coverage from the American Association for Cancer Research (AACR) 2018 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.

Preoperative pembrolizumab is safe and effective among patients with muscle-invasive urothelial bladder carcinoma (MIUC), according to research presented at the 2018 American Association for Cancer Research Annual Meeting in Chicago, Illinois.1

For the phase 2 PURE-01 study (ClinicalTrials.gov Identifier: NCT02736266), researchers administered 3 cycles of neoadjuvant pembrolizumab 200 mg to 34 patients with MIUC scheduled to undergo radical cystectomy (RC). Eligible patients had predominant urothelial carcinoma histology, had T3bN0 or less disease, and were susceptible to cisplatin or carboplatin therapy. Biomarker analyses were conducted during transurethral resection of the bladder (TURB) and post-RC.

Twenty-two patients were evaluable at the time of analysis. Seven (31.8%) patients had a pathologic complete response (pT0) and 3 had noninvasive disease/carcinoma in situ (pTa/is).

An analysis of TURB samples showed that all patients with pT0 had a PD-L1 combined positive score (CPS) exceeding 20% compared with 10% or less among non-pT0 patients. Patients who were responsive to treatment had a tumor mutational burden (TMB) of 12.28 mut/mb compared with 7.02 mut/mb among others.

One instance of grade 3 alanine aminotransferase elevation and 5 instances of reversible immune-related adverse events were observed.

Interim data demonstrated a strong association between CPS, pT0, higher TMB, and pT response ≤2, leading the authors to conclude that the study, once completed, may potentially be “practice changing.”

Read more of Cancer Therapy Advisor's coverage of the American Association for Cancer Research (AACR) 2018 meeting by visiting the conference page.

Reference

  1. Necchi A, Briganti A, Bianchi M, et al. Preoperative pembrolizumab (pembro) before radical cystectomy (RC) for muscle-invasive urothelial bladder carcinoma (MIUC): interim clinical and biomarker findings from the phase II PURE-01 study. Oral presentation at: 2018 American Association for Cancer Research Annual Meeting; April 14-18, 2018; Chicago, IL.

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