Genentech’s Tecentriq® (ATEZOLIZUMAB) Plus Platinum-based Chemotherapy Reduced the Risk of Disease Worsening or Death in People With Previously Untreated Advanced Bladder Cancer

– IMvigor130 is the first positive Phase III study of a cancer immunotherapy combination in previously untreated advanced bladder cancer –

– Data will be shared with health authorities globally, including the U.S. Food and Drug Administration (FDA)

SOUTH SAN FRANCISCO, CA, USA I August 05, 2019 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMvigor130 study met its co-primary endpoint of investigator-assessed progression-free survival (PFS). The combination of Tecentriq® (atezolizumab) plus platinum-based chemotherapy showed a statistically significant reduction in the risk of disease worsening or death in people with previously untreated locally advanced or metastatic urothelial carcinoma (mUC) compared with chemotherapy alone. Encouraging overall survival (OS) results were observed at this interim analysis, however these data are not yet mature and follow-up will continue until the next planned analysis.

Safety in the Tecentriq plus chemotherapy arm appeared consistent with the known safety profiles of the individual medicines and no new safety signals were identified with the combination. Results will be presented at an upcoming medical meeting and shared with health authorities globally, including the U.S. Food and Drug Administration (FDA).

“IMvigor130 is the first positive Phase III study of a cancer immunotherapy combination in previously untreated advanced bladder cancer, an aggressive disease with high unmet need,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “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.”

Tecentriq was the first cancer immunotherapy approved in bladder cancer. Tecentriq has accelerated approval from the FDA for the treatment of adults with locally advanced or mUC, including those who are not eligible for cisplatin-containing chemotherapy and whose tumors express high levels of PD-L1 (PD-L1–stained tumor-infiltrating immune cells covering ≥5 percent of the tumor area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The accelerated approval also includes the treatment of adults with locally advanced or mUC whose disease had progressed during or following platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). These accelerated approvals are based on tumor response rate and durability of response. Continued approval in these types of bladder cancer may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Currently, there are four ongoing Phase III studies evaluating Tecentriq alone and in combination with other medicines in early and advanced bladder cancer. Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMvigor130 study

IMvigor130 is a multicenter, partially blinded, randomized Phase III study, evaluating the efficacy and safety of Tecentriq in combination with chemotherapy or alone versus chemotherapy alone for people with mUC who have not received prior systemic therapy for metastatic disease. It enrolled 1,213 people that were randomized to receive:

  • Tecentriq plus platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin), or
  • Tecentriq, or
  • Platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin) plus placebo (control arm).

In the Tecentriq combination arm, the co-primary endpoints are OS and PFS as assessed by investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

About bladder cancer

According to the American Cancer Society (ACS), it is estimated that more than 80,000 Americans will be diagnosed with bladder cancer in 2019, and about 11 percent of new diagnoses are made when bladder cancer is in advanced stages. There is a dramatic difference in survival rates between early and advanced bladder cancer. The ACS estimates that approximately 90 percent of people will live five or more years when diagnosed with the earliest stage of the disease, compared to 40 percent when diagnosed in advanced stages (stage III-IV) of the disease. Men are about three to four times more likely to get bladder cancer during their lifetime than women.

About Tecentriq® (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq U.S. Bladder Indications

Tecentriq is a prescription medicine used to treat adults with:

A type of bladder and urinary tract cancer called urothelial carcinoma.

Tecentriq may be used when your bladder cancer:

  • has spread or cannot be removed by surgery, and if you have any one of the following conditions:
    • you are not able to take chemotherapy that contains a medicine called cisplatin, and your doctor has tested your cancer and found high levels of a specific protein on your cancer called programmed death-ligand 1 (PD-L1), or
    • you are not able to take chemotherapy that contains any platinum regardless of the levels of “PD-L1” status, or
    • you have tried chemotherapy that contains platinum, and it did not work or is no longer working

The approval of Tecentriq in these patients is based on a study that measured response rate and duration of response. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

About Genentech in personalized cancer immunotherapy

For more than 30 years, Genentech has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever to bring personalized cancer immunotherapy (PCI) to people with cancer. The goal of PCI is to provide each person with a treatment tailored to harness his or her own immune system to fight cancer. Genentech is studying more than 10 cancer immunotherapy medicines across 70 clinical trials alone or in combination with other medicines. In every study we are evaluating biomarkers to identify which people may be appropriate candidates for our medicines. For more information visit http://www.gene.com/cancer-immunotherapy.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

SOURCE: Genentech

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