- Roche announced Wednesday morning that its key cancer drug Tecentriq (atezolizumab) failed to meet the primary endpoint in a Phase 3 trial for locally advanced or metastatic urothelial cancer (mUC).
- The drug got an accelerated approval from the Food and Drug Administration in this bladder indication in April. The approval was contingent on further study results validating the effectiveness of the checkpoint inhibitor.
- Tecentriq was the first immunotherapy approved as an initial treatment in bladder cancer, despite being the third PD-1/L1 inhibitor on the market. Roche targeted the bladder cancer indication first as a way to secure market ahead of Bristol-Myers Squibb and Merck & Co.
Roche said May 10 that Tecentriq failed to meet its primary endpoint of overall survival compared with chemotherapy in the Phase 3 IMvigor211 trial.
Tecentriq’s previous conditional approval was based on data from the Phase 2 IMvigor210 trial. The FDA granted Tecentriq a first-line approval in bladder cancer, while both Bristol-Myers’ Opdivo (nivolumab) and AstraZeneca’s Imfinzi (durvalumab) only have second-line indications. Pfizer and Merck KGaA gained approval in second-line bladder cancer yesterday for their checkpoint inhibitor Bavencio (avelumab).
The accelerated approval process allows the FDA to approve a drug based on limited clinical trial data, speeding the time it takes for drugs to get to market. Yet, the system has its drawbacks; the drugs approved under the process need to prove that they are as safe and effective as earlier studies have shown. Most of the data the agency bases accelerated approval on is usually from Phase 2 and earlier.
IMvigor211 was meant to validate the initial approval of Tecentriq in second-line bladder cancer, while another Phase 3 trial, IMvigor130, is ongoing and meant to validate the approval in first-line bladder cancer.
The failure calls into question whether Roche’s Tecentriq should’ve gotten approval in the first place. The company did not comment on what the agency will do next.