Atezolizumab FDA indication for pretreated bladder cancer voluntarily withdrawn

The withdrawal comes after the confirmatory phase 3 IMvigor211 study missed its primary end point.

Roche (Genentech) has voluntarily withdrawn the FDA indication for the PD-L1 inhibitor atezolizumab (Tecentriq) for use in patients with locally advanced or metastatic urothelial carcinoma (mUC) previously treated with platinum-based chemotherapy.1

Atezolizumab received an accelerated approval from the FDA for this indication in May 2016 based on cohort data from the phase 2 IMvigor210 study.2 However, an FDA accelerated approval is contingent upon the results of a confirmatory trial, and in May 2017, Roche reported that the phase 3 IMvigor211 study exploring atezolizumab in the second-line setting for patients with locally advanced or (mUC) missed its primary end point of improving overall survival (OS).3

“The Accelerated Approval Program allows people with difficult-to-treat cancers to receive certain new therapies earlier,” Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, stated in a press release. “While the withdrawal of Tecentriq for prior-platinum treated bladder cancer is disappointing, Tecentriq continues to demonstrate benefits across multiple cancer types and therefore remains a meaningful treatment option for many patients.”

The phase III IMvigor211 study included 931 patients with previously treated mUC who progressed during or following a platinum-based regimen. Patients were randomized to atezolizumab or investigator’s choice of chemotherapy, which included vinflunine, paclitaxel, or docetaxel. Treatment in both arms was administered every 3 weeks. Patients were required to have an ECOG performance status of 0 or 1 and evaluable tumor samples for PD-L1 testing.

The IMvigor 210 cohort on which the accelerated approval of second-line atezolizumab was based included an all-comer population of 316 patients with inoperable locally advanced or mUC who progressed after receiving platinum-based chemotherapy. Data from 310 patients were evaluable. The patients had been heavily pretreated, with 40% of patients undergoing 2 or more prior systemic regimens in the metastatic setting and 74% of patients receiving previous cisplatin-based chemotherapy.

At a median follow-up of 14.4 months, the overall response rate (ORR) was 14.8% (n = 46/310) in all comers, 26% (n = 26/100) in patients with PD-L1 expression ≥5%, and 9.5% (n = 20/210) in those with PD-L1 expression <5%. In a subgroup of 59 patients from the IMvigor 210 study who progressed after neoadjuvant or adjuvant platinum-based chemotherapy, the ORR was 22%.

Complete response rates in the overall, higher—PD-L1, and lower–PD-L1 groups were 5.5%, 12%, and 2.4%, respectively. Partial response rates were 9.4%, 14%, and 7.1%, respectively. The median duration of response was 12.7 months (range, 2.1+ to 12.7) in the lower PD-L1 population, and had not yet been reached in either the overall group or the higher PD-L1 cohort.

This is the second recent voluntary withdrawal of an FDA indication for second-line bladder cancer. On February 22, AstraZeneca voluntarily withdrew the FDA indication for the PD-L1 inhibitor durvalumab (Imfinzi) for use in previously treated patients with locally advanced or metastatic bladder cancer.


1. Roche provides update on Tecentriq US indication in prior-platinum treated metastatic bladder cancer. Posted online March 8, 2021. Accessed March 8, 2021.

2. Hoffman-Censits JH, Grivas P, Van Der Heijden MS, et al. IMvigor 210, a phase II trial of atezolizumab (MPDL3280A) in platinum-treated locally advanced or metastatic urothelial carcinoma (mUC). J Clin Oncol 34, 2016 (suppl 2S; abstr 355). doi: 10.1200/jco.2016.34.2_suppl.355

3. Roche provides update on phase III study of TECENTRIQ® (atezolizumab) in people with previously treated advanced bladder cancer. Posted online May 10, 2017. Accessed March 8, 2021.

Related Videos
Eric A. Singer, MD, MA, FACS, an expert on bladder cancer
Eric A. Singer, MD, MA, FACS, an expert on bladder cancer
Eric A. Singer, MD, MA, FACS, an expert on bladder cancer
Eric A. Singer, MD, MA, FACS, an expert on bladder cancer
Dr. Diana Magee in an interview with Urology Times
Dr. Brian Chun in an interview with Urology Times
Jacob Taylor, MD, MPH, answers a question during a Zoom video interview
blurred photo of a clinic hallway
Related Content
© 2023 MJH Life Sciences

All rights reserved.