Adding Tecentriq (atezolizumab) to standard chemotherapy reduced the risk of disease worsening or death in previously untreated patients with locally advanced or metastatic urothelial cancer, according to early results of a Phase 3 trial
Also, according to Genentech — the company marketing Tecentriq — the analysis showed encouraging overall survival results, but definitive conclusions will only be possible after a longer follow-up.
Safety results in patients on Tecentriq and chemotherapy were consistent with the safety profiles of the individual medicines. No new safety signals were identified. The team is planning to present these findings at an upcoming medical meeting and share them with health authorities globally, including the U.S. Food and Drug Administration (FDA).
The multi-center IMvigor130 study (NCT02807636) is comparing the efficacy and safety of the combination of Tecentriq with platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin) to either Tecentriq alone or chemotherapy with placebo.
The trial, expected to be completed by November 2020, randomized 1,213 patients not previously treated with systemic therapies to either study group.
“IMvigor130 is the first positive Phase III study of a cancer immunotherapy combination in previously untreated advanced bladder cancer,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech and Roche (which owns Genentech), said in a press release.
Tecentriq is an immune checkpoint inhibitor. By binding to the PD-L1 protein on cancer cells, the therapy blocks its interaction with PD-1 on T cells, a mechanism used by tumor cells to evade immune attack.
Urothelial cancer is the most common type of bladder cancer. Tecentriq was the first immunotherapy approved in bladder cancer. It is available in the United States following accelerated approval by the FDA to treat adults with locally advanced or metastatic urothelial cancer, including those not eligible for cisplatin-containing chemotherapy and whose tumors express high levels of PD-L1, or not eligible for platinum-based chemotherapy regardless of PD-L1 status.
Patients whose disease worsened during or after platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before or after surgery, may also be treated with Tecentriq.
Continued approval for these indications may depend on clinical benefits seen in a confirmatory trial, according to Genentech.
Four Phase 3 trials are assessing Tecentriq, either alone or in combination therapies, in early and advanced bladder cancer. Several other Phase 3 studies are testing or will test Tecentriq across lung, breast, genitourinary, skin, gastrointestinal, gynecological, and head and neck cancers.
“These results support our broad clinical development program for Tecentriq in bladder cancer, as well as our approach of combining immunotherapy with chemotherapy or other medicines to improve patient outcomes, and we look forward to discussing them with health authorities,” Horning said.