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Confirmatory study of atezolizumab for advanced bladder cancer fails to meet primary endpoint
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A randomized phase 3 trial that evaluated atezolizumab for treatment of locally advanced or metastatic urothelial cancer failed to meet its primary endpoint, according to the drug’s manufacturer.
The FDA previously granted accelerated approval to atezolizumab (Tecentriq, Genentech) — a monoclonal antibody designed to bind with PD-L1 — for initial treatment of patients with locally advanced or metastatic urothelial carcinoma. The agency based the accelerated approval on results from the phase 2 IMvigor210 study, which demonstrated the agent’s positive effects on tumor response rate and duration of response.
The IMvigor211 trial — designed to serve as the confirmatory study to convert the accelerated approval to full approval in the United States — evaluated the safety and efficacy of atezolizumab compared with chemotherapy administered every 3 weeks to 931 patients with locally advanced or metastatic urothelial cancer whose disease progressed during or after treatment with platinum-based chemotherapy.
IMvigor211 was a randomized pivotal study designed to support full approval globally and to serve as the confirmatory study to convert the accelerated approval to full approval in the U.S.
OS — tested in a successive fashion in study populations defined by PD-L1 expression — served as the primary endpoint. Results showed atezolizumab did not significantly extend OS compared with chemotherapy.
“While these results are not what we had expected, we believe that Tecentriq will continue to play an important role in the treatment of people with advanced bladder cancer,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a company-issued press release. “We are committed to helping people with advanced bladder cancer and will discuss these data with health authorities.”
Complete data from the trial will be presented later this year, according to the press release.
Atezolizumab’s safety profile appeared consistent with previous studies of the drug.
The phase 3 confirmatory IMvigor130 study of atezolizumab as initial treatment for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin chemotherapy is ongoing. The FDA previously granted accelerated approval to atezolizumab for this patient population.
Thirty other trials are underway to evaluate atezolizumab alone or in combination for the treatment of lung, kidney, skin, breast, colorectal, prostate, ovarian, bladder and blood cancers.