Genentech’s Tecentriq (Atezolizumab) as a First-Line Monotherapy Helped Certain People With Advanced Non-Small Cell Lung Cancer Live Longer Compared With Chemotherapy

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

SOUTH SAN FRANCISCO, CA, USA I September 12, 2019 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive data from the Phase III IMpower110 study evaluating Tecentriq® (atezolizumab) as a first-line (initial) monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without ALK or EGFR mutations (wild-type; WT). The study met its primary endpoint in an interim analysis showing that Tecentriq monotherapy demonstrated a statistically significant overall survival (OS) benefit in people with high PD-L1 expression (TC3/IC3-WT), compared with chemotherapy alone. Safety for Tecentriq appeared to be consistent with its known safety profile and no new safety signals were identified. The study will continue to final analysis for people with lower levels of PD-L1 expression.

“We are encouraged that Tecentriq monotherapy has shown a significant survival benefit over chemotherapy as an initial treatment in people with squamous or non-squamous non-small cell lung cancer with high PD-L1 expression,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “These findings reinforce the potential of Tecentriq to play an important role in the treatment of multiple forms of lung cancer, and we look forward to discussing these data with health authorities.”

Genentech will now submit these data to global health authorities, including the FDA and EMA, and will discuss how best to bring this option to patients as quickly as possible. These data will be presented at an upcoming medical meeting.

Currently, Genentech has nine Phase III lung cancer studies underway evaluating Tecentriq as a monotherapy or in combination with other medicines across different types of lung 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 IMpower110 study

IMpower110 is a Phase III, randomized, open-label study to evaluate the efficacy and safety of Tecentriq monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with advanced non-squamous or squamous NSCLC without ALK or EGFR mutations (wild-type; WT).

A total of 555 people (555 WT) were enrolled and were randomized 1:1 to receive:

  • Tecentriq monotherapy, until loss of clinical benefit (as assessed by the investigator), or
  • Cisplatin or carboplatin (per investigator discretion) combined with either pemetrexed (non-squamous) or gemcitabine (squamous), followed by maintenance therapy with pemetrexed alone (non-squamous) or best supportive care (squamous) until disease progression, unacceptable toxicity or death.

The primary efficacy endpoint is OS by PD-L1 subgroup (TC3/IC3-WT; TC2/3/ IC2/3-WT; and TC1,2,3/IC1,2,3-WT), as determined by the SP142 assay test. Key secondary endpoints include investigator-assessed progression-free survival (PFS), objective response rate (ORR) and duration of response (DoR).

About lung cancer

According to the American Cancer Society, it is estimated that more than 228,000 Americans will be diagnosed with lung cancer in 2019, and NSCLC accounts for 80-85% of all lung cancers. It is estimated that approximately 60% of lung cancer diagnoses in the United States are made when the disease is in the advanced stages.

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. Indications

Tecentriq is a prescription medicine used to treat adults with:

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

  • Tecentriq may be used with bevacizumab and the chemotherapy medicines carboplatin and paclitaxel as your first treatment when your lung cancer:
    • has spread or grown, and
    • is a type of lung cancer called “non-squamous NSCLC”, and
    • your tumor does not have an abnormal “EGFR” or “ALK” gene
  • Tecentriq may be used alone when your lung cancer:
    • has spread or grown, and
    • you have tried chemotherapy that contains platinum, and it did not work or is no longer working, and
    • If your tumor has an abnormal “EGFR” or “ALK” gene, you 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 lung cancer called small cell lung cancer (SCLC).

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

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

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 in lung cancer

Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have five approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

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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