Basel, 5 May 2021 ? Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Tecentriq? (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression*, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations.

?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., Roche?s Chief Medical Officer and Head of Global Product Development. ?Tecentriq monotherapy has been shown to improve overall survival in people with high PD-L1 expression, 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 dosing options, allowing administration every two, three or four weeks, giving physicians and patients greater flexibility on how they manage their treatment.

This approval is based on data from the Phase III IMpower110 study, which showed that Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (median OS=20.2 versus 13.1 months; hazard ratio [HR]=0.59, 95% CI: 0.40?0.89; p=0.0106) in people with high PD-L1 expression (TC3 or IC3-wild-type [WT]).¹?Safety for Tecentriq was consistent with its known safety profile, with no new safety signals identified. Grade 3?4 treatment-related adverse events were reported in 12.9% of people receiving Tecentriq, compared with 44.1% of people receiving chemotherapy.²

Tecentriq has shown clinically meaningful benefit in various types of lung cancer, with five currently approved indications in markets around the world. In Europe, Tecentriq now has four approved indications in NSCLC, including as a single agent or in combination with targeted therapies and/or chemotherapies. It was also the first approved cancer immunotherapy for the first-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy).

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across different settings in lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumour types.

About the IMpower110 study IMpower110 is a Phase III, randomised, open-label study evaluating the efficacy and safety of Tecentriq monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in PD-L1-selected, chemotherapy-na?ve participants with Stage IV non-squamous or squamous NSCLC. The study enrolled 572 people, of whom 554 were in the intention-to-treat WT population, which excluded people with EGFR or ALK genomic tumour aberrations, and were randomised 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 (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 was 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 included investigator-assessed progression-free survival, objective response rate and duration of response.

At the World Conference on Lung Cancer 2020 (January 2021), an updated, exploratory OS analysis in the PD-L1 high (TC3 or IC3)-WT population showed a continued OS benefit at a median follow-up of 31.3 months (HR=0.76, 95% CI: 0.54?1.09). Median OS in the Tecentriq arm was the same as observed at the previous analysis (20.2 months); in the chemotherapy arm, median OS was 14.7 months.³?Data from this exploratory OS analysis were also submitted to the European Commission.

PD-L1 is a protein expressed on tumour cells and tumour-infiltrating cells, which suppresses the immune response and enables tumour cells to avoid detection by binding to proteins on the surface of immune cells. Immunotherapies such as Tecentriq block PD-L1 from binding to immune cells, allowing the immune system to detect and destroy tumour cells. In IMpower110, patients were classified as PD-L1 high if they had PD-L1 on at least 50% of tumour cells or if PD-L1 expressing tumour-infiltrating cells were covering at least 10% of the tumour area.

About NSCLC Lung cancer is the one of the leading causes of cancer death globally.⁴?Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day.⁴?Lung cancer can be broadly divided into two major types: NSCLC and SCLC. NSCLC is the most prevalent type, accounting for around 85% of all cases.⁵?NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.⁵

About?Tecentriq Tecentriq is a monoclonal antibody designed to bind with a protein called Programmed Death Ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person?s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either 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-negative breast cancer and for hepatocellular carcinoma. In the US, Tecentriq is also approved in combination with Cotellic? (cobimetinib) and Zelboraf? (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.

About Roche in cancer immunotherapy Roche?s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 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 goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.

In addition to Roche?s approved PD-L1 checkpoint inhibitor, Tecentriq? (atezolizumab), Roche?s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies.

To learn more about Roche?s scientific-led approach to cancer immunotherapy, please follow this link: http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htm

About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people?s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare ? a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world?s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better 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 by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit?www.roche.com.

*High programmed death ligand-1 (PD-L1) expression in the indication statement is defined as PD-L1 stained =50% of tumour cells (TC) [TC =50%] or PD-L1 stained tumour-infiltrating cells (IC) covering =10% of the tumour area [IC =10%]. PD-L1 staining is the process by which the PD-L1 protein is visualised during testing.

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References [1] Herbst RS, et al. Atezolizumab for first-line treatment of PD-L1-selected patients with NSCLC. N Engl J Med 2020:383:1328?39. [2] Supplement to: Herbst RS, et al. Atezolizumab for first-line treatment of PD-L1-selected patients with NSCLC. N Engl J Med 2020;383:1328?39. [3] Herbst RS, et al. IMpower110: updated OS analysis of atezolizumab vs platinum-based chemotherapy as first-line treatment in PD-L1?selected NSCLC [WCLC 2020 Poster FP13.03]. [4] 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. [5] 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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