Roche : Tecentriq in combination with pemetrexed and platinum-based chemotherapy reduced the risk of disease worsening or death in a type of previously untreated advanced lung cancer

Basel, 24 September 2018

Roche's Tecentriq in combination with pemetrexed and platinum-based chemotherapy reduced the risk of disease worsening or death in a type of previously untreated advanced lung cancer

• Data will be presented at the 2018 World Conference on Lung Cancer (WCLC) and also featured in the WCLC press programme on 24 September 2018

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the Phase III IMpower132 study of Tecentriq^® (atezolizumab) plus pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) for the initial (first-line) treatment of people with non-squamous, non-small cell lung cancer (NSCLC). This interim analysis showed that Tecentriq and chemotherapy reduced the risk of disease worsening or death (progression-free survival, PFS) by 40% compared with chemotherapy alone (PFS=7.6 versus 5.2 months; hazard ratio [HR]=0.60, 95% CI: 0.49-0.72; p<0.0001).¹ While a numerical improvement of 4.5 months for the co-primary endpoint of overall survival (OS) was observed, at this interim analysis statistical significance has not yet been met (median OS=18.1 versus 13.6 months; HR=0.81, 95% CI: 0.64-1.03; p=0.0797). The study will continue as planned, with final OS results expected next year. Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination.

'This is our third Phase III trial in non-squamous non-small cell lung cancer demonstrating that a Tecentriq -based regimen can help reduce the risk of disease progression for people living with this disease,' said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. 'We will discuss these results with health authorities globally.'

Data will be presented at the International Association for the Study of Lung Cancer (IASLC) 2018 World Conference on Lung Cancer (WCLC) on Monday 24 September at 14:35-14:45 EDT (Abstract OA05.07 Oral) and featured in the official WCLC press conference at 09:45-10:30 EDT.

About the IMpower132 study

IMpower132 is a Phase III, open-label, randomised study evaluating the efficacy and safety of Tecentriq plus chemotherapy (cisplatin or carboplatin and pemetrexed) versus chemotherapy alone in chemotherapy-naïve patients with NSCLC. The study enrolled 578 people who were randomised equally (1:1) to receive:

• Tecentriq in combination with cisplatin or carboplatin and pemetrexed (Arm A),
• or Cisplatin or carboplatin and pemetrexed (Arm B, control arm)

During the treatment-induction phase, people received Tecentriq, pemetrexed and investigator's choice of either cisplatin or carboplatin on Day 1 of every three weeks for a dosing period of four or six cycles. People who experienced clinical benefit during the induction phase began maintenance therapy until disease progression.

The co-primary endpoints were:

• PFS as determined by the investigator using RECIST v1.1
• OS

IMpower132 met its PFS co-primary endpoint as per the study protocol. A summary of the results are included below:

Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. Grade 3-4 treatment-related adverse events (AEs) were reported in 53.6 percent of people receiving Tecentriq plus chemotherapy compared to 39.1 percent of people receiving chemotherapy alone.

About NSCLC

Lung cancer is the leading cause of cancer death globally.² Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.² Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.³ 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.³

About Tecentriq

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 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 has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has eight Phase III lung cancer studies evaluating Tecentriq alone or in combination with other medicines.

Tecentriq is already approved in the European Union, United States and more than 70 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).

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.

To learn more about the Roche 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. 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 tenth consecutive year, Roche has been recognised as the most sustainable company 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 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 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.