Genentech’s Tecentriq in Combination With Chemotherapy (Including Abraxane) Meets Primary Endpoint of Improved Pathological Complete Response, Regardless of PD-L1 Status, as Initial Treatment for People With Early Triple-negative Breast Cancer

IMpassion031 data will be discussed with health authorities globally, including the U.S. Food and Drug Administration and the European Medicines Agency

Tecentriq is the only approved cancer immunotherapy for the treatment of metastatic triple-negative breast cancer, a very aggressive and difficult-to-treat form of breast cancer

SOUTH SAN FRANCISCO, CA, USA I June 17, 2020 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpassion031 study, evaluating Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane ® [albumin-bound paclitaxel; nab-paclitaxel]; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chemotherapy (including Abraxane), met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in pathological complete response (pCR) for the treatment of people with early triple-negative breast cancer (TNBC), regardless of PD-L1 expression.

“Triple-negative breast cancer remains an aggressive disease with high rates of recurrence,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Our goal in treating TNBC at its earliest stages is to provide people with the best chance for a future cure. Adding Tecentriq to chemotherapy now has the potential to help women with TNBC at multiple different stages of the disease.”

In the study, fewer patients who received the Tecentriq combination as a neoadjuvant (before surgery) treatment had evidence of tumor tissue detectable at the time of surgery (known as pCR), regardless of PD-L1 expression, in comparison to the control arm. Neoadjuvant treatment may allow a doctor to quickly assess whether a medicine is working, and may also reduce a tumor's size so it is easier to surgically remove. pCR is a common measure of neoadjuvant treatment effect in breast cancer and can be assessed more quickly than traditional endpoints in early-stage breast cancer.

Safety for the Tecentriq combination appeared to be consistent with the known safety profiles of the individual medicines and no new safety signals were identified. Results of the IMpassion031 study will be presented at an upcoming medical meeting and will be discussed with global health authorities including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

The IMpassion031 study is the second positive Phase III study from Genentech demonstrating the benefit of Tecentriq in TNBC, and the first Tecentriq study to demonstrate benefit in early TNBC. Tecentriq in combination with nab-paclitaxel is currently approved in more than 70 countries worldwide, including the U.S. and across Europe, for the treatment of adults with unresectable locally advanced or metastatic TNBC in people whose tumors express PD-L1 (IC≥1%).

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 IMpassion031 study
The IMpassion031 study is a Phase III, multi-center, randomized, double-blind study evaluating the efficacy and safety of Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel]; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chemotherapy, in people with previously untreated, early TNBC. The primary endpoint is pCR using the American Joint Committee on Cancer (AJCC) staging system in the intention-to-treat (ITT) population and in the PD-L1-positive population. Secondary endpoints include overall survival (OS), event-free survival, disease-free survival and quality of life measures.

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.

About triple-negative breast cancer
Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, close to 280,000 people in the United States will be diagnosed with invasive breast cancer, and more than 42,000 will die from the disease in 2020. Breast cancer is not one, but many diseases based on the biology of each tumor. In triple-negative breast cancer, tumor cells lack hormone receptors and do not have excess HER2 protein. Approximately 15 percent of breast cancers are triple-negative based on the results of diagnostic tests. It is an aggressive form of the disease with few treatment options.

Tecentriq U.S. Indications (pronounced ‘tē-SEN-trik’)
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 in patients with urothelial carcinoma if their bladder cancer has spread or cannot be removed by surgery, and if they have any one of the following conditions:

  • They are not able to take chemotherapy that contains a medicine called cisplatin and their cancer tests positive for “PD-L1” or
  • They are not able to take chemotherapy that contains any platinum regardless of the levels of “PD-L1” status or
  • They 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 the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

A type of lung cancer called non-small cell lung cancer (NSCLC).

Tecentriq may be used alone as the first treatment in patients with lung cancer if:

  • Their cancer has spread or grown and
  • Their cancer tests positive for “high PD-L1”, and
  • Their tumor does not have an abnormal “EGFR” or “ALK” gene.

Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as the first treatment in patients with lung cancer if:

  • Their cancer has spread or grown, and
  • Is a type called “non-squamous NSCLC”, and
  • Their tumor does not have an abnormal “EGFR” or “ALK” gene.

Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as the first treatment in patients with lung cancer if:

  • Their cancer has spread or grown, and
  • Is a type called “non-squamous NSCLC”, and
  • Their tumor does not have an abnormal “EGFR” or “ALK” gene.

Tecentriq may be used alone in patients with lung cancer if:

  • Their cancer has spread or grown and
  • They have tried chemotherapy that contains platinum, and it did not work or is no longer working

If a patient’s tumor has an abnormal EGFR or ALK gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.

A type of breast cancer called triple-negative breast cancer (TNBC).

Tecentriq may be used with the medicine paclitaxel protein-bound in patients with TNBC when their breast cancer:

  • Has spread or cannot be removed by surgery and
  • Their cancer tests positive for “PD-L1”

The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

A type of lung cancer called small cell lung cancer (SCLC).

  • Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as the first treatment in patients with SCLC when their lung cancer is a type of lung cancer called “extensive-stage small cell lung cancer,” which means that it has spread or grown.

A type of liver cancer called hepatocellular carcinoma (HCC).

  • Tecentriq may be used with the medicine bevacizumab when a patient’s liver cancer:
    • has spread or cannot be removed by surgery, and
    • the patient has not received other medicines by mouth or injection through their vein (IV) to treat their cancer.

It is not known if Tecentriq is safe and effective in children.

Please visit http://www.Tecentriq.comfor the full Tecentriq Prescribing Information for additional Important Safety Information.

About Genentech in cancer immunotherapy
Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system.

In addition to Genentech’s approved PD-L1 checkpoint inhibitor, the company’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. 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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