Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that China National Medical Products Administration (NMPA) has approved Tecentriq (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

'Small cell lung cancer is an area of major unmet need in China and one that has seen limited advances until now,' said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. 'This approval makes Tecentriq the first cancer immunotherapy available in China for the initial treatment of extensive-stage small cell lung cancer less than a year after the US FDA and EMA approvals, marking a swift and important step forward for patients with this aggressive and difficult-to-treat disease.'

Lung cancer is the most common cancer and the leading cause of cancer death in China.1 Overall, SCLC accounts for around 15% of all lung cancer cases and, with two-thirds of patients diagnosed at the 'extensive' stage, the prognosis for people with this form of the disease is poor.2 The average five-year survival for people with ES-SCLC is only 2%.3

This approval is based on results from the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared with chemotherapy alone (median overall survival [OS]=12.3 versus 10.3 months; HR=0.70, 95% CI: 0.54-0.91; p=0.0069). The combination also significantly reduced the risk of disease worsening or death (progression-free survival [PFS]) compared with chemotherapy alone (median PFS=5.2 versus 4.3 months; hazard ratio [HR]=0.77; 95% CI: 0.62-0.96; p=0.017).4 Follow-up analysis suggests that at 18 months the OS rate was 34% for people receiving the Tecentriq-based treatment versus 21% for people receiving chemotherapy alone. Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq. The results represent the first clinically meaningful advance in the first-line treatment of ES-SCLC in more than 20 years.

In January 2020, the China NMPA also accepted the supplemental Biologics License Application (sBLA) for Tecentriq in combination with Avastin (bevacizumab) for the treatment of people with unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer, who have not received prior systemic therapy. The submission is based on the results from the Phase III IMbrave150 study, which met both of its co-primary endpoints, demonstrating statistically significant and clinically meaningful improvements in OS and PFS compared with current standard of care, sorafenib.

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMpower133 study

IMpower133 is a Phase III, multicentre, double-blinded, randomised placebo-controlled study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and etoposide) versus chemotherapy (carboplatin and etoposide) alone in chemotherapy-naive adults with ES-SCLC. The study enrolled 403 people who were randomised equally (1:1) to receive: Tecentriq in combination with carboplatin and etoposide (Arm A), or Placebo in combination with carboplatin and etoposide (Arm B, control arm During the treatment-induction phase, people received treatment on 21-day cycles for four cycles, followed by maintenance with Tecentriq or placebo until progressive disease (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1). Treatment could be continued until persistent radiographic PD or symptomatic deterioration was observed.

The co-primary endpoints were PFS, as determined by the investigator using RECIST v1.1 and OS in the intention-to-treat (ITT) population.

About SCLC

Lung cancer is the leading cause of cancer death globally.5 Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.5 Lung cancer can be broadly divided into two major types: non-small cell lung cancer (NSCLC) and SCLC, with SCLC accounting for approximately 15% of all lung cancer cases.2

About Tecentriq

Tecentriq is a monoclonal antibody designed to bind with a protein called 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 non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

About Roche in cancer immunotherapy

For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we're investing more than ever in our effort to bring innovative treatment options that help a person's own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

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 eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

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