Roche’s cancer immunotherapy shrank tumors in 24% of patients

June 6, 2016

Roche recently announced that its IMvigor210, Tecentriq (atezolizumab), in a Phase II study, shrank tumors in 24% of people with locally advanced or metastatic urothelial carcinoma (mUC) who have not received a prior first-line treatment and who were ineligible for cisplatin-based chemotherapy. Roche is a global biotech company and a pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.

Of those people who responded, 75% continued to respond to treatment and the median duration of response (mDOR) had not been reached at the time of analysis. Seven percent of all people in the study achieved a complete response. The median overall survival was 14.8 months. The safety profile of Tecentriq was consistent with that observed in earlier analyses of the study, as well as in other studies of Tecentriq as a monotherapy. Full results will be presented in an oral session at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) and highlighted as part of ASCO’s official press program.

Tecentriq is a monoclonal antibody designed to target and bind to a protein called PD-L1 (programmed death ligand-1), which is expressed on tumor cells and tumor-infiltrating immune cells. PD-L1 interacts with PD-1 and B7.1, both found on the surface of T cells, causing inhibition of T cells. By blocking this interaction, Tecentriq may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells.

“These Tecentriq results are highly encouraging because about half of all people with this type of bladder cancer are not able to tolerate a cisplatin-based chemotherapy, and alternative treatments bring very limited duration of response,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. “We are particularly pleased that the majority of people who responded to Tecentriq continued to respond at the time of analysis.”

IMvigor210 is an open-label, multicenter, single-arm phase II study that evaluated the safety and efficacy of Tecentriq in people with locally advanced or mUC, regardless of PD-L1 expression. People in the study were enrolled into one of two cohorts. Cohort 1 consisted of people who had received no prior therapies for locally advanced or mUC and who were ineligible for first-line cisplatin-based chemotherapy. Cohort 2 included people whose disease progressed during or following previous treatment with a platinum-based chemotherapy regimen (second-line or later). The primary endpoint of the study was ORR. Secondary endpoints included duration of response (DOR), overall survival (OS), progression-free survival (PFS) and safety. PD-L1 (programmed death-ligand 1) expression was assessed using an immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics.

Full results from IMvigor210 Cohort 1 will be presented by Arjun Balar, MD, Director of Genitourinary Medical Oncology at Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY. Updated results from IMvigor 210 Cohort 2, the trial upon which Tecentriq received U.S. Food and Drug Administration accelerated approval for the treatment of people with locally advanced or mUC who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant), will be presented by Robert Dreicer, Associate Director of Clinical Research, Hematology and Oncology, University of Virginia School of Medicine, Charlottesville, Va. in an oral session.

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