FDA Approves Advanced Bladder Cancer Immunotherapy

The FDA today granted accelerated approval for atezolizumab (Tecentriq) for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) in patients who have disease progression during or after platinum-based chemotherapy, or whose disease worsened within 12 months of platinum-based chemotherapy before or after surgery.

Atezolizumab is a monoclonal antibody that binds with the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells. The drug blocks interactions with both PD-1 and B7.1 receptors to enable the activation of T cells.

The approval was based on an open-label, multicenter, 2 cohort phase 2 study that evaluated the safety and efficiency of Tecentriq in patients with locally advanced or mUC, regardless of PD-L1 expression.

There were 310 patients enrolled who received a 1200-mg dose of Tecentriq intravenously on the first day of the 21-day cycles, until they experienced unacceptable toxicity or had either radiographic or clinical progression. There was a median follow-up time of 14.4 months.

The study was assessed by an independent review facility that used the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 to determine the primary endpoint of objective response rate (ORR) and secondary endpoints involving duration of response (DOR).

Among a subset of people in the IMvigor 210 study with disease progression after neoadjuvant or adjuvant platinum-based therapy (n=59), Tecentriq was found to shrink tumors in 22% (95 percent CI: 12.3, 34.7) of people.

The most common adverse reactions (≥ 2%) included urinary tract infection, anemia, fatigue, dehydration, intestinal obstruction (partial or complete), urinary obstruction, hematuria, dyspnea, acute kidney injury, abdominal pain, venous thromboembolism, sepsis, and pneumonia.

There were 3 patients who experienced sepsis, intestinal obstruction, or pneumonitis that resulted in mortality. Tecentriq was discontinued in 10 of 310 patients because of adverse reactions.

“Even though bladder cancer is the fifth most commonly diagnosed cancer in the United States, it hasn’t received the same attention within the cancer community as other common cancers,” said Diane Zipursky Quale, president and co-founder, Bladder Cancer Advocacy Network. “Tecentriq is a new medicine for people whose locally advanced or metastatic bladder cancer has progressed on platinum-based chemotherapy and may have limited treatment options.”