Roche announced it was voluntarily withdrawing the U.S. indication Tecentriq for in prior-platinum treated metastatic urothelial carcinoma (mUC) after failing to meet endpoints in confirmatory trials.
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Two weeks after AstraZeneca withdrew the use of Imfinzi as a treatment for bladder cancer in the United States, Swiss pharma giant Roche is following suit with its checkpoint inhibitor Tecentriq (atezolizumab).
This morning, Roche announced it was voluntarily withdrawing the U.S. indication Tecentriq for in prior-platinum treated metastatic urothelial carcinoma (mUC) after failing to meet endpoints in confirmatory trials. Working in conjunction with the U.S. Food and Drug Administration (FDA), Roche said it will strive to complete the withdrawal process over the next few weeks.
Tecentriq was granted accelerated approval by the FDA for this indication in 2016 based on results from a cohort in the IMvigor210 study. The FDA’s Accelerated Approval Program allows people with difficult-to-treat cancers to receive certain new therapies earlier. However, part of the conditions for accelerated approval include post-marketing requirements that confirm the safety and efficacy of the treatment.
In the case of Tecentriq, which generated approximately $3 billion in revenue last year, that post-marketing study failed to be met. Continued approval for this indication was contingent upon the results of IMvigor211, the original post-marketing requirement for the prior-platinum treated mUC indication. However, the study failed to meet its primary endpoint of overall survival in the PD-L1 high patient population. Hints to this failure were first seen in 2017 when Tecentriq failed to hit the mark in a Phase III bladder cancer study as a second-line treatment.
Following that failure, the FDA designated the IMvigor130 study as the PMR which will still continue until the final analysis. In the IMvigor130 study, Tecentriq is being paired with chemotherapy in this indication. Although that study is ongoing, the company decided to go ahead and withdraw Tecentriq in this indication due to improvements in the treatment landscape in second-line mUC.
The decision to pull Tecentriq in this indication does not affect other approved indications for Tecentriq, which include non-small cell lung cancer, small cell lung cancer, certain types of bladder cancer, a kind of triple-negative breast cancer and for liver cancer. Roche will work with healthcare professionals as patients being treated with Tecentriq will have to find other options.
Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, called the withdrawal of Tecentriq for prior-platinum treated bladder cancer “disappointing.” However, he said Tecentriq continues to demonstrate benefits across multiple cancer types and therefore remains a meaningful treatment option for many patients.
Both Roche’s Tecentriq and AstraZeneca’s Imfinzi are checkpoint inhibitors, meaning they are monoclonal antibody designed to bind with a protein called Programmed Death Ligand-1 (PD-L1), which is expressed on tumor cells and tumor-infiltrating immune cells.
