Roche announced Tuesday it will voluntarily withdraw Tecentriq (atezolizumab) from the U.S. market for treating bladder cancer, marking the end of the immunotherapy's accelerated approvals that failed to gain confirmation through subsequent clinical trials.
The Swiss pharmaceutical company will no longer market the PD-L1 inhibitor for any form of urothelial carcinoma, the first cancer type for which Tecentriq received FDA approval more than six years ago. This decision follows consultation with the FDA regarding results from the phase 3 IMVigor130 trial, which failed to meet its co-primary endpoint of overall survival.
Failed Confirmatory Trial Results
The IMVigor130 study tested Tecentriq in combination with chemotherapy against chemotherapy alone in patients with metastatic bladder cancer. Results showed patients receiving the Tecentriq-chemotherapy combination lived a median of 16 months after treatment, compared with 13.4 months for those receiving chemotherapy alone—a difference that was not statistically significant.
The multicenter, randomized, placebo-controlled trial enrolled patients with untreated advanced urothelial cancer who were eligible to receive platinum-based chemotherapy. Patients were randomly assigned to receive intravenous atezolizumab at 1200 mg once every 3 weeks alone, the same dosing schedule of atezolizumab plus chemotherapy, or chemotherapy plus placebo.
Regulatory Context and Industry Impact
The withdrawal represents the completion of Roche's removal of "dangling" accelerated approvals for Tecentriq. The company had previously narrowed the drug's label to cover only patients who couldn't take chemotherapy or whose tumors express the PD-L1 protein that Tecentriq targets, after clinical trial results questioned whether the drug helped patients live longer.
"While we are disappointed with this withdrawal, we understand the need to uphold the principles of the U.S. FDA's Accelerated Approval Program, which brings innovative medicines to patients sooner," said Levi Garraway, Roche's chief medical officer and head of global product development.
The decision reflects broader FDA scrutiny of accelerated approvals in oncology. Immunotherapy competitors Merck & Co. and Bristol Myers Squibb have also withdrawn indications for their drugs Keytruda and Opdivo, sometimes driven by FDA decisions to call in outside advisers for consultation. Last week, GSK pulled its multiple myeloma drug Blenrep after a confirmatory study failed.
Clinical Implications
The original accelerated approval was granted in April 2017 based on findings from the phase 2 IMVigor210 trial for cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma. The withdrawal specifically affects the indication for adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 tumor proportion score of at least 5%, or who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
"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 OS," Garraway stated.
With this withdrawal, Roche will only sell Tecentriq in tumor types for which it has received full FDA approval, typically based on trial data showing the drug can help patients survive or delay cancer progression longer than comparator treatments. The withdrawal will not affect any other indications for atezolizumab in the United States.
Detailed findings from IMVigor130 are scheduled to be presented at an upcoming medical meeting, providing the oncology community with comprehensive data on the trial's outcomes and implications for future bladder cancer treatment strategies.
