Atezolizumab FDA indication for pretreated bladder cancer voluntarily withdrawn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Roche (Genentech) has voluntarily withdrawn the FDA indication for the PD-L1 inhibitor atezolizumab (Tecentriq) for use in patients with locally advanced or metastatic urothelial carcinoma (mUC)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.

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