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- Tecentriq significantly improved overall survival in people with high PD-L1 expression, compared to chemotherapy in a Phase III study
- Tecentriq approval offers an alternative to chemotherapy for all eligible patients
- This approval mark Tecentriq’s fourth indication for metastatic non-small cell lung cancer and fifth indication for lung cancer in general in the EU
Basel, May 5, 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved Tecentriq® (atezolizumab) as a first-line (initial) treatment for adults with non-small cell lung cancer metastatic (NSCLC) whose tumors have high expression of PD-L1 *, without epidermal growth factor receptor (EGFR) or genomic tumor aberrations of anaplastic lymphoma kinase (ALK).
“We are delighted to bring Tecentriq to people in the EU with this specific type of lung cancer,” said Levi Garraway, M.D., Ph.D., Medical Director and Head of Global Product Development at Roche. “Tecentriq monotherapy has been shown to improve overall survival in people with high expression of PD-L1 when compared to chemotherapy and therefore represents a new treatment option for people living with this difficult-to-treat disease.”
Tecentriq is now the first and only single agent cancer immunotherapy with three dosage options, allowing administration every two, three or four weeks, giving doctors and patients more flexibility on how to administer their treatment.
This approval is based on data from the Phase III IMpower110 study, which showed that Tecentriq monotherapy improved overall survival (SG) by 7.1 months compared to chemotherapy (median SG = 20.2 versus 13.1 months; risk ratio [HR]= 0.59, 95% CI: 0.40-0.89; p = 0.0106) in people with high expression of PD-L1 (TC3 or wild-type IC3 [WT])1 Tecentriq’s security was consistent with its known security profile, with no new security signs identified. Grade 3-4 treatment-related adverse events were reported in 12.9% of people who received Tecentriq, compared with 44.1% of people who received chemotherapy.two
Tecentriq has demonstrated clinically significant benefits in several types of lung cancer, with five indications currently approved in markets around the world. In Europe, Tecentriq now has four NSCLC approved indications, including as a single agent or in combination with targeted therapies and / or chemotherapies. It was also the first cancer immunotherapy approved for the first-line treatment of adults with large stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy).
Roche has an extensive development program for Tecentriq, including several Phase III studies in progress and planned in different configurations of lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancer. This includes studies evaluating Tecentriq alone and in combination with other drugs, as well as studies in metastatic, adjuvant and neoadjuvant configurations in various types of tumor.
About the IMpower110 study
IMpower110 is a Phase III, randomized, open-label study that evaluates the efficacy and safety of Tecentriq monotherapy compared to cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in PD-L1-selected, non-scaly or stage IV chemotherapy participants Scaly NSCLC. The study involved 572 people, of whom 554 were in the WT population with an intention to treat, which excluded people with EGFR or ALK genomic tumor aberrations, and were randomized 1: 1 to receive:
- Tecentriq monotherapy, until disease progression (or loss of clinical benefit, as assessed by the investigator), unacceptable toxicity or death; or
- Cisplatin or carboplatin (at the investigator’s discretion) combined with pemetrexed (not scaly) or gemcitabine (scaly), followed by maintenance therapy with pemetrexed alone (not scaly) or better supportive care (scaly) until disease progression, unacceptable toxicity or death.
The primary efficacy endpoint was OS per PD-L1 subgroup (TC3 / IC3-WT; TC2,3 / IC2,3-WT; and TC1,2,3 / IC1,2,3-WT), as determined by test SP142 test. The main secondary outcomes included progression-free survival assessed by the investigator, objective response rate and duration of the response.
At the World Lung Cancer Conference 2020 (January 2021), an updated exploratory analysis of OS in the high PD-L1 population (TC3 or IC3) -WT showed a continuous OS benefit over an average follow-up of 31.3 months (HR = 0.76, 95% CI: 0.54-1.09). The median SG in the Tecentriq arm was the same observed in the previous analysis (20.2 months); in the chemotherapy arm, the median SG was 14.7 months.3 The data from this exploratory SO analysis was also submitted to the European Commission.
PD-L1 is a protein expressed in tumor cells and tumor infiltrating cells, which suppresses the immune response and allows tumor cells to avoid detection by binding to proteins on the surface of immune cells. Immunotherapies like Tecentriq block the binding of PD-L1 to immune cells, allowing the immune system to detect and destroy tumor cells. In IMpower110, patients were classified as high PD-L1 if they had PD-L1 in at least 50% of the tumor cells or if PD-L1 expressing infiltrating tumor cells covered at least 10% of the tumor area.
Lung cancer is a leading cause of cancer death worldwide.4 Each year, 1.8 million people die from the disease; this translates to more than 4,900 deaths worldwide every day.4 Lung cancer can be broadly divided into two main types: NSCLC and SCLC. NSCLC is the most prevalent type, accounting for about 85% of all cases.5 The NSCLC comprises non-squamous and squamous cell cancer, whose squamous shape is characterized by flat cells that cover the surface of the airways when viewed under a microscope.5
Tecentriq is a monoclonal antibody designed to bind to a protein called Programmed Death Ligand-1 (PD-L1), which is expressed in tumor cells and tumor-infiltrating immune cells, blocking their interactions with PD-1 and B7 receptors. 1. By inhibiting PD-L1, Tecentriq may allow the activation of T cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a key combination partner with other immunotherapies, targeted drugs and various chemotherapies in a wide range of cancers. The development of Tecentriq and its clinical program is based on our greater understanding of how the immune system interacts with tumors and how controlling a person’s immune system fights cancer more effectively.
Tecentriq is approved in the US, EU and countries around the world, alone or in combination with targeted therapies and / or chemotherapies in various forms of NSCLC, SCLC, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple cancer negative breast and for hepatocellular carcinoma. In the USA, Tecentriq has also been approved in combination with Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of people with advanced melanoma positive for the BRAF V600 mutation.
About Roche in cancer immunotherapy
Roche’s rigorous search for innovative science has contributed to the main therapeutic and diagnostic advances in oncology in the past 50 years and, today, realizing the full potential of immunotherapy against cancer is an important area of focus. With more than 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone and in combination with chemotherapy, targeted therapies or other immunotherapies with the aim of providing each person with a treatment tailored to take advantage of their own unique immune system to attack your cancer. Our scientific experience, together with innovative lines and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer, ensuring the right treatment for the right patient at the right time.
In addition to the Roche-approved PD-L1 checkpoint inhibitor, Tecentriq® (atezolizumab), Roche’s broad line of cancer immunotherapy includes other checkpoint inhibitors, such as tiragolumab, a new cancer immunotherapy designed to bind to TIGIT, individualized neoantigens and bispecific T cell antibodies.
To learn more about Roche’s scientific approach to cancer immunotherapy, follow this link:
Roche is a global pioneer in pharmaceuticals and diagnostics with a focus on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare – a strategy that aims to tailor the right treatment to each patient in the best possible way.
Roche is the largest biotechnology company in the world, with truly differentiated drugs in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also a world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a pioneer in diabetes control.
Founded in 1896, Roche continues to seek the best ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations, working with all relevant stakeholders. More than thirty medications developed by Roche are included in the World Health Organization’s Essential Medicines Model Lists, including antibiotics, antimalarials and life-saving cancer drugs. In addition, for the twelfth consecutive year, Roche was recognized as one of the most sustainable companies in the Pharmaceutical Industry by the Dow Jones Sustainability Index (DJSI).
The Roche Group, based in Basel, Switzerland, is active in more than 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and recorded sales of CHF 58.3 billion. Genentech, in the United States, is a full member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information please visit www.roche.com.
* The elevated expression of programmed death ligand-1 (PD-L1) in the statement of indication is defined as PD-L1 staining ≥50% of tumor cells (CT) [TC ≥50%] or infiltrating tumor cells (CI) stained with PD-L1 covering ≥10% of the tumor area [IC ≥10%]. PD-L1 staining is the process by which the PD-L1 protein is visualized during the test.
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 Herbst RS, et al. Atezolizumab for the first-line treatment of patients selected with PD-L1 with NSCLC. N Engl J Med 2020: 383: 1328–39.
 Supplement for: Herbst RS, et al. Atezolizumab for the first-line treatment of patients selected with PD-L1 with NSCLC. N Engl J Med 2020; 383: 1328–39.
 Herbst RS, et al. IMpower110: updated OS analysis of atezolizumab versus platinum-based chemotherapy as first-line treatment in NSCLC selected by PD-L1 [WCLC 2020 Poster FP13.03].
 World Health Organization: GLOBOCAN 2020 – Lung Cancer: Estimated cancer incidence, mortality and prevalence worldwide. [Internet; cited March 2021] Available from: https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
 American Cancer Society: What is lung cancer? [Internet; cited March 2021]: Available from: https://www.cancer.org/cancer/lung-cancer/about/what-is.html.
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