Investor Update

Basel, 29 September 2014

Roche presents preliminary combination data for anti-PDL1 medicine (MPDL3280A) with Avastin (bevacizumab)

  • Early data indicate the combination with Avastin in first line metastatic renal cell carcinoma (mRCC) is safe and well tolerated
  • Monotherapy MPDL3280A data indicate a potential association between expression of PD-L1 and response rates in pretreated patients with mRCC
  • Encouraging combination safety data were observed in metastatic colorectal cancer (mCRC)

Roche (SIX: RO, ROG; OTCQX: RHHBY) has announced the first combination data of its investigational cancer immunotherapy MPDL3280A and Avastin in untreated patients with mRCC.  Roche also presented monotherapy data for MPDL3280A in patients with mRCC who had been mostly pretreated. In addition, encouraging combination data were observed in a variety of other tumour types including metastatic colorectal cancer (mCRC). MPDL3280A was well tolerated both as a single agent and in combination.

Results from the phase Ib study showed that the combination of MPDL3280A and Avastin was well tolerated and shrank tumours (ORR) in 40 percent (4/10) of people with previously untreated mRCC.  Furthermore, preliminary data with monotherapy show that in pretreated mRCC, patients who had levels of PD-L1 expression (IHC1/2/3) were more likely to respond to MPDL3280A versus patients with no detectable expression of PD-L1 (IHC 0), 20 percent (n=35) versus 10 percent (n=21) respectively. The overall response rates for these patients was 15 percent (n=62).

“These data in renal cell carcinoma are encouraging and add weight to the growing body of evidence that supports the use of MPDL3280A in multiple tumour types,” said Sandra Horning, M.D., Chief Medical Officer and head of Global Product Development. “Moreover, these data encourage us to further examine the benefits of pursuing combination therapies with MPDL3280A in appropriate clinical settings.”

The primary objectives of these phase 1 cohort groups were safety and tolerability, with secondary objectives including ORR and duration of response (DOR).1,2 Full results of these data sets will be presented at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid (Abstract #10490, Saturday, September  27, 11:15am, Barcelona Room & Abstract 8090, Monday, September  29, 11:30am, Sevilla Room).

About MPDL3280A (anti-PDL1)

MPDL3280A (also known as anti-PDL1) is an investigational monoclonal antibody designed to interfere with a protein called PD-L1. MPDL3280A 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, MPDL3280A may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells.

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 are investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer. Our cancer immunotherapy research and development programme comprises more than 20 investigational candidates, which include the evaluation of biomarkers to determine which people may be appropriate candidates for our medicines.

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-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 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. Lieu C et al. Safety and efficacy of MPDL3280A (anti-PDL1) in combination with bevacizumab and/or chemotherapy in patients with locally advanced or metastatic solid tumours. Abstract number: #10490. 29 September 2014, 11:15am CET, Madrid, Spain
2. McDermott DF et al. Immune correlates and long term follow up of a Phase I1 study of MPDL3280A, an engineered PD-L1 antibody, in patients with metastatic renal cell carcinoma (mRCC). Abstract number: #8090. 27 September 2014, 11:30am CET, Madrid, Spain