Genentech withdraws atezolizumab frontline indication for metastatic urothelial carcinoma


Genentech (Roche) has decided to voluntarily withdraw its US indication for atezolizumab (Tecentriq) for the frontline treatment of patients with advanced urothelial carcinoma.1

The indication was specifically for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or those who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

Atezolizumab received an accelerated approval from the FDA for this indication in April 2017; however, an FDA accelerated approval is contingent upon the results of a confirmatory trial, and the subsequent phase 3 IMvigor130 trial (NCT02807636) failed to show that adding atezolizumab to chemotherapy would improve overall survival (OS) vs chemotherapy alone in this patient population.

Genentech reported in a press release that these OS data will be shared at a future medical meeting.

“While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA’s Accelerated Approval Program, which brings innovative medicines to patients sooner. We remain confident in the benefit Tecentriq offers to people diagnosed with some of the most difficult-to-treat forms of cancer,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, Genentech (Roche).

“There is a considerable unmet need for effective and tolerable treatments for people living with advanced bladder cancer and so we regret that the IMvigor130 trial did not cross the statistical threshold for overall survival,” added Garraway.

The multicenter phase 3 IMvigor130 study randomized 1213 patients with previously untreated locally advanced or mUC to atezolizumab plus platinum-based chemotherapy (451 patients), atezolizumab monotherapy (362), or placebo plus platinum-based chemotherapy (400).

The co-primary end points were progression-free survival (PFS) and OS. Although OS was not improved with the addition of atezolizumab to chemotherapy, add-on immunotherapy did improve the co-primary PFS end point. Initial data from the trial showed a median PFS of 8.2 months with atezolizumab plus chemotherapy compared with 6.3 months with placebo plus chemotherapy (HR, 0.82; P = .007).2

The is the second FDA-approved indication for atezolizumab in advanced bladder cancer that Genentech (Roche) has voluntarily withdrawn. Previously, the company withdrew atezolizumab’s indication for use in patients with locally advanced or mUC previously treated with platinum-based chemotherapy.3 In a similar situation as the frontline indication, atezolizumab received an accelerated approval for the second-line indication but a confirmatory phase 3 trial (IMvigor211) missed its primary end point of improved OS in this setting.

Genentech noted in the press release that other approved US indicationS for atezolizumab are not affected by the frontline mUC withdrawal, and that US patients currently receiving frontline atezolizumab for mUC should discuss next steps with their healthcare provider.


1. Genentech provides update on Tecentriq US indication for previously untreated metastatic bladder cancer. Posted online and accessed November 28, 2022.

2. Galsky MD, Arija JÁA, Bamias A, et al. Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10236):1547-1557. doi: 10.1016/S0140-6736(20)30230-0

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

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