Bladder Cancer Coverage from Every Angle

Immune Checkpoint Inhibitors in Urothelial Bladder Cancer: Changing the Treatment Game

By: Julia Fiederlein
Posted: Tuesday, June 29, 2021

Several trials combining chemotherapy with immune checkpoint inhibitors have resulted in approvals from the U.S. Food and Drug Administration (FDA), and subsequent revisions to the NCCN Clinical Practice Guidelines in Oncology, according to Arlene O. Siefker-Radtke, MD, Professor of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, and member of the NCCN panel for bladder cancer. These new settings for immune checkpoint inhibitors in urothelial bladder cancer were discussed in detail in her presentation during the NCCN 2021 Virtual Annual Conference, highlights of which were published in JNCCN–Journal of the National Comprehensive Cancer Network.

Pembrolizumab was granted approval by the FDA and incorporated into the guidelines for the treatment of patients with Bacillus Calmette-Guérin–unresponsive, high-risk non–muscle-invasive bladder cancer (carcinoma in situ). According to Dr. Siefker-Radtke, immune checkpoint inhibitors may also be used to prolong the benefits of first-line systemic chemotherapy; the use of avelumab as a maintenance strategy is FDA-approved. Per the NCCN Guidelines, patients who achieved stable disease or better after receiving cisplatin or carboplatin may be administered avelumab until disease progression.

In addition, patients with urothelial tumors may benefit from front-line chemotherapy followed by immune checkpoint inhibition at disease progression. The FDA approved the use of pembrolizumab, and it was integrated into the NCCN Guidelines as the preferred regimen for the second-line treatment of locally advanced or metastatic disease. Nivolumab and avelumab have received early approval and are also included in the NCCN Guidelines. As a result of negative trials, in 2021, durvalumab and atezolizumab were voluntarily withdrawn for this indication.

Immune checkpoint inhibitors have been administered concurrently with chemotherapeutic agents and in the adjuvant treatment of urothelial carcinoma. However, they have not been FDA-approved or incorporated into the NCCN Guidelines in these clinical contexts.

“There are multiple other settings where immune checkpoint inhibitors are currently under study and are showing promise,” Dr. Siefker-Radtke concluded. “We hope to be able to add to the FDA approval list.”

Disclosure: For full disclosures for Dr. Siefker-Radtke, visit

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