Genentech has voluntarily withdrawn the US indication for Tecentriq® (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (PD-L1-stained tumor-infiltrating immune cells covering ≥5% of the tumor area) or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

In 2017, Tecentriq received accelerated approval for this indication based on tumor response rate and duration of response from the phase 2 IMvigor210 study (ClinicalTrials.gov Identifier: NCT02951767). Continued approval required further verification and description of clinical benefit in a confirmatory trial.

After consultation with the Food and Drug Administration (FDA), the decision to withdraw the indication was made based on findings from the subsequent confirmatory phase 3 IMvigor130 trial (ClinicalTrials.gov Identifier: NCT02807636), which evaluated Tecentriq plus platinum-based chemotherapy for the first-line treatment of patients with previously untreated advanced bladder cancer. Results showed that treatment with Tecentriq plus chemotherapy did not meet the coprimary endpoint of overall survival compared with chemotherapy alone.

The Company will be working with the FDA in the coming weeks to complete the withdrawal process. The withdrawal of the Tecentriq indication does not affect other approved US indications for Tecentriq. Patients who are receiving Tecentriq for previously untreated metastatic urothelial carcinoma should consult with their health care provider.

“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,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “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.”

References

  1. Genentech provides update on Tecentriq US indication for previously untreated metastatic bladder cancer. News release. Genentech. November 28, 2022. Accessed December 5, 2022. https://www.gene.com/media/statements/ps_112822.
  2. Tecentriq. Package insert. Genentech; 2022. Accessed December 5, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761034s050lbl.pdf.