Investor Update

Basel, 01 June 2015

Roche's investigational cancer immunotherapy atezolizumab (anti-PDL1, MPDL3280A) shrank tumours in two thirds of people with the most common type of lung cancer when combined with chemotherapy in a Phase 1b study

  • Atezolizumab plus chemotherapy shrank tumours in 67 percent of people with advanced disease
  • Data suggest atezolizumab (MPDL3280A) can be combined with chemotherapy and was well tolerated, with no unexpected toxicities
  • 3 Phase III studies of atezolizumab in combination with chemotherapy in 1L NSCLC have been initiated

Roche (SIX: RO, ROG; OTCQX: RHHBY) will present encouraging results from a Phase Ib study of the investigational cancer immunotherapy atezolizumab (MPDL3280A), in combination with a range of platinum-based chemotherapy combinations commonly used in the treatment of non-small cell lung cancer (NSCLC). The study showed that atezolizumab, a PD-L1 (programmed death ligand-1) inhibitor, shrank tumours (objective response rate; ORR) in 67 percent (20/30) of people with advanced NSCLC when combined with chemotherapy. The addition of atezolizumab to chemotherapy was well tolerated and no unexpected toxicities were reported. The most frequent adverse events (AEs) included those commonly associated with chemotherapy, such as nausea, fatigue and constipation. The data will be presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO).1

"We are encouraged that a high proportion of people responded to combined treatment with atezolizumab (MPDL3280A) and chemotherapy in this early lung cancer study,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development.  “This result indicates that combinations may provide a way to extend the benefits of atezolizumab to a wider range of people, including those with low levels of PD-L1 expression."

Roche currently has three ongoing Phase III studies of atezolizumab in combination with chemotherapy in previously untreated advanced NSCLC.

About the Phase Ib study of atezolizumab in combination with platinum-based doublet chemotherapy

  • This multicentre, multi-armed study aimed to evaluate the safety and efficacy of atezolizumab in combination with platinum-based doublet chemotherapy in patients with histologically or cytologically documented Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent NSCLC
  • Patients received atezolizumab combined with carboplatin plus either paclitaxel (Arm C), pemetrexed (Arm D) or nab-paclitaxel (Arm E)
  • 37 patients were given atezolizumab 15 mg/kg IV q3w with standard chemotherapy for 4–6 cycles followed by atezolizumab maintenance therapy until progression; 30 patients were evaluable for efficacy at the time of this data cut
  • PD-L1 expression was centrally assayed using the SP142 immunohistochemistry (IHC) antibody

About atezolizumab

Atezolizumab (also known as MPDL3280A) is an investigational monoclonal antibody designed to interfere with a protein called PD-L1. Atezolizumab is designed to target PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on the surface of T cells. By inhibiting PD-L1, atezolizumab may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells.

About non-small cell lung cancer

Lung cancer is the leading cause of cancer death globally. Each year, 1.59 million people die as a result of the disease, which means more than 4,350 deaths worldwide every day. 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.

About Roche in lung cancer

Lung cancer is a major area of focus and investment for Roche, 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 three 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 Roche in cancer immunotherapy

For more than 30 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.

About personalised cancer immunotherapy

The aim of personalised cancer immunotherapy (PCI) is to provide individual patients with treatment options that are tailored to their specific needs. Our PCI research and development programme comprises more than 20 investigational candidates, seven of which are in clinical trials. All studies include the prospective evaluation of biomarkers to determine which people may be appropriate candidates for our medicines. In the case of atezolizumab (also known as MPDL3280A), PCI begins with the PD-L1 (programmed death ligand-1) IHC assay based on the SP142 antibody developed by Roche. The goal of PD-L1 as a biomarker is to identify those people most likely to experience clinical benefit with atezolizumab as a single agent and which people may be appropriate candidates for combination therapies; the purpose is not to exclude patients from atezolizumab therapy, but rather to enable the design of combinations that will provide the greatest chance for transformative responses. The ability to combine atezolizumab with multiple chemotherapies may provide new treatment options to people across a broad range of tumours regardless of their level of PD-L1 expression.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-eight medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 billion Swiss francs. 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.

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References
1. Liu SV, et al. Safety and efficacy of MPDL3280A (anti-PDL1) in combination with platinum-based doublet chemotherapy in patients with advanced non-small cell lung cancer (NSCLC), Abstract number: #8030. 1 June 2015, 8:00 CDT, Chicago, United States