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FDA Adds PD-L1 Expression to Frontline Pembrolizumab, Atezolizumab Urothelial Carcinoma Labels

Silas Inman @silasinman
Published: Wednesday, Jun 20, 2018

The FDA has incorporated PD-L1 status into the labels for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for existing frontline approvals for cisplatin-ineligible patients with urothelial carcinoma, based on lower overall survival (OS) rates with the PD-1/PD-L1 inhibitors compared with platinum-based chemotherapy for patients with PD-L1–low expressing platinum-eligible urothelial carcinoma.

Several clinical trials exploring checkpoint inhibitors remain ongoing for patients with urothelial carcinoma. The single-arm phase II KEYNOTE-057 study is enrolling participants with high-risk non-muscle invasive bladder cancers (NMIBC) who are unresponsive to bacillus Calmette-Guérin (BCG) therapy (NCT02625961). Additionally, studies are ongoing to assess neoadjuvant treatment with pembrolizumab prior to cystectomy for patients with muscle-invasive bladder cancer (NCT02736266). These studies do not have strict PD-L1 testing requirements for entry.

References

  1. Bellmunt J, de Wit R, Vaughn DJ, et al. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N Engl J Med. 2017;376(11):1015-1026. doi: 10.1056/NEJMoa1613683.
  2. Balar AV, Castellano D, O'Donnell PH, et al. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017;18(11):1483-1492.
  3. Balar AV, Galsky MD, Rosenberg JE, et al. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017;389(10064):67-76.

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