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ESMO conference: Roche's Tecentriq sees split early results in bladder cancer

Roche Holding AG's Tecentriq and chemotherapy improved the survival of certain bladder cancer patients without their disease worsening during a phase 3 clinical trial, but the therapy has not met its goal for improving the overall survival of patients at the mid-point of the trial.

A combination of Tecentriq plus chemotherapy is being compared with chemotherapy alone in patients with bladder cancer that is either advanced or has spread to other parts of the body in the study called IMvigor130, Roche unit Genentech Inc. said in a Sept. 30 press release. The therapy combination is specifically being investigated as an initial treatment for this type of cancer in previously untreated patients.

Interim results of the trial were released at the European Society for Medical Oncology, which is taking place in Barcelona, Spain.

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Tecentriq is part of a class of tumor-targeting drugs called checkpoint inhibitors. The therapy blocks the PD-L1 protein on cancer cells from linking with a partner arm on healthy cells — an interaction that prevents the spread of the disease.

In the IMvigor130 study, the immunotherapy and chemotherapy improved the survival of patients without their disease progressing to 8.2 months, compared to 6.3 in patients receiving chemotherapy alone. However, Genentech said the combination has not reached statistical significance at the interim data point of the trial in terms of the overall survival of patients. The Tecentriq arm saw patients survive 16 months, while the chemotherapy-only patients survived for 13.4 months.

The split results mean IMvigor130 has so far met one of two primary goals. No new safety concerns for Tecentriq have been noted during the trial.

Tecentriq was previously granted accelerated approval by the U.S. Food and Drug Administration for treating bladder cancer in patients with a certain gene mutation who are not eligible for chemotherapy. The approval also includes patients with advanced disease, or those whose cancer has spread, whose disease was not controlled by chemotherapy, and as a pre-surgery treatment after receiving chemotherapy, or post-surgical treatment regimen. Continued approval in these indications is contingent upon the submission of data to support the benefits of the therapy.

The therapy is also approved for treating lung cancer in the EU and U.S.

Genentech said another four clinical trials are underway in bladder cancer with Tecentriq alone and in combination. The drug is also being examined in other clinical trials in other types of cancer, including lung, skin and breast.

Results from a separate clinical trial of Tecentriq in lung cancer were also released during ESMO.

The European Society for Medical Oncology is holding its 2019 scientific meeting in Barcelona, where more than 3,900 study abstracts have been submitted for review by oncology professionals from around the world.