Media Release Basel, November 2013 Roche s Gazyva helped people with one of the most common forms of blood cancer live significantly longer without their disease worsening compared to MabThera/Rituxan in phase III CLL11 study Second stage of CLL11 study showed Gazyva plus chlorambucil significantly reduced the risk of disease worsening or death by 61% compared to MabThera/Rituxan plus chlorambucil for people with previously untreated chronic lymphocytic leukemia Updated data from Stage 1a of CLL11 showed Gazyva plus chlorambucil improved overall survival compared to chlorambucil alone Full CLL11 study results to be presented during the Plenary Scientific Session of the 55 th Annual Meeting of the American Society of Hematology (ASH) Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new, positive data from the second stage of the CLL11 study. This phase III study, conducted in cooperation with the German CLL Study Group, compared Gazyva (obinutuzumab), also known as GA101, in combination with chlorambucil to MabThera/Rituxan (rituximab) in combination with chlorambucil for people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. The data showed that people treated in the Gazyva arm lived nearly a year longer without their disease worsening (progression-free survival, or PFS). For patients in the Gazyva arm, median PFS was 26. months compared with 15.2 months for those in the MabThera/Rituxan arm (HR 0.39, CI 0.31-0.49, p<0.0001). No new safety signals were observed for either Gazyva or MabThera/Rituxan. The data have been accepted for presentation during the Plenary Scientific Session of the 55th Annual Meeting of American Society of Hematology (Abstract #6). F. Hoffmann-La Roche Ltd 400 Basel Switzerland Group Communications Roche Group Media Relations Tel. +41 61 688 88 88 Fax +41 61 688 2 5 www.roche.com 1/5
Gazyva is the result of years of research for patients with chronic lymphocytic leukemia, said Hal Barron, MD, Roche s Chief Medical Officer and Head of Global Product Development. These new data are important because they showed for the first time that Gazyva significantly extended progression-free survival when directly compared against MabThera/Rituxan. Additional data comparing the Gazyva and MabThera/Rituxan treatment arms showed higher complete response rates (21% compared with %) and a ten-fold increase in the percentage of people achieving minimal residual disease (MRD) negativity (29.4% compared with 2.5%), which was defined as no detectable disease in the blood at the end of the treatment course. In addition to the Stage 2 data being presented at ASH, an updated analysis from the first stage (Stage 1a) of the CLL11 study, which compared Gazyva in combination with chlorambucil to chlorambucil alone, will also be presented. This analysis showed that people treated with Gazyva in combination with chlorambucil lived longer (overall survival, or OS) compared to chlorambucil alone (HR 0.41, 95% CI 0.23-0.4 p=0.002). Given the median observation time of 23 months, median overall survival has not yet been reached in any of the study arms. On 1 November 2013, Gazyva in combination with chlorambucil became the first medicine with Breakthrough Therapy Designation to receive U.S. Food and Drug Administration (FDA) approval. Roche has also submitted Marketing Authorisation Applications to other regulatory authorities around the world, including the European Medicines Agency (EMA). The following data related to Gazyva will be also presented during the ASH Annual Meeting: Safety and Efficacy of Obinutuzumab (GA101) with Fludarabine/Cyclophosphamide (G- FC) or Bendamustine (G-B) in the Initial Therapy of Patients with Chronic Lymphocytic Leukemia (CLL): Results from the phase 1b GALTON Trial (GAO49g) (Abstract #523) Safety and Efficacy Of Obinutuzumab (GA101) Plus CHOP Chemotherapy In First-Line Advanced Diffuse Large B-Cell Lymphoma: Results From The phase 2 Gather Study (GAO4915g) (Abstract #1820) Obinutuzumab (GA101) Plus CHOP or FC in Relapsed/Refractory Follicular Lymphoma: Final Data From the Maintenance phase of the phase 1b GAUDI Study (BO21000) (Abstract #1814)
About the CLL11 study CLL11 is a phase III, multicentre, open-label, randomised three-arm study investigating the efficacy and safety profile of Gazyva plus chlorambucil, MabThera/Rituxan plus chlorambucil and chlorambucil alone in 81 previously untreated people with CLL and co-existing medical conditions who are in need of therapy. Stage 1 (n=589) compared Gazyva plus chlorambucil to chlorambucil alone and MabThera/Rituxan plus chlorambucil to chlorambucil alone. Stage 2 (n=663) compared Gazyva plus chlorambucil directly with MabThera/Rituxan plus chlorambucil. The primary endpoint of the study was PFS with secondary endpoints including overall response rate (ORR), overall survival (OS), disease free survival (DFS), minimal residual disease (MRD) and safety profile. Stage 2 results (investigator assessed) Total N = 663 Gazyva plus chlorambucil N=333 MabThera/Rituxan plus chlorambucil N=330 Overall response rate (ORR), %* Complete response (CR), %* Median PFS, months Hazard Ratio, 95% Cl, p-value log rank test Median OS, months HR, Cl, p 8 21 65 26. # 15.2 0.39. 0.31-0.49, p <0.0001 0.66, 0.41-1.06, p=0.09 Minimal residual disease 63/214 [29.4%] 6/243 [2.5%] Grade 3-5 adverse events, %** Grade 3-5 Infusion-related reactions %*** Grade 3-5 Neutropenia (low count of certain white blood cells) %*** Grade 3-5 Infections % * ** *** # At end-of-treatment During treatment No deaths (grade 5 AE) in these categories Still immature Not reached 66 20 33 4 4 2 About chronic lymphocytic leukemia Chronic lymphocytic leukemia is the most common type of leukemia in the Western world. Each year it causes approximately 5,000 deaths across the globe.
About Gazyva Gazyva is a new monoclonal antibody designed to attach to CD20, a protein found only on B cells. It attacks targeted cells both directly and together with the body's immune system. Gazyva was discovered by Roche Glycart AG, a wholly owned, independent research unit of Roche. In the U.S., Gazyva is part of a collaboration between Genentech and Biogen Idec. In the U.S., Gazyva is now approved in combination with chlorambucil for people with previously untreated chronic lymphocytic leukemia. Globally, Gazyva is also being investigated in a large clinical programme, including multiple head-to-head phase III studies compared to MabThera/Rituxan in indolent non-hodgkin lymphoma (NHL) and diffuse large B-cell lymphoma (DLBCL). About the German CLL Study Group (GCLLSG) Founded in 1996 and headed by Professor Michael Hallek, the GCLLSG has been running various phase I, II and III trials with the goal providing optimal treatment to patients suffering from CLL. This included landmark trials like CLL8, which led to the current standard of care in CLL. For many years, GCLLSG has been aiming to improve not just the treatment of younger and physically fit patients, but also that of elderly and less fit patients. These patients are generally underrepresented in clinical trials although they constitute the majority of CLL patients treated by doctors in daily practice. The GCLLSG is an independent non-profit research organisation supported by German Cancer Aid (Deutsche Krebshilfe). About Roche in hematology For more than 20 years, Roche has been developing medicines that redefine treatment in hematology. Today, we re investing more than ever in our effort to bring innovative treatment options to people with cancers of the blood. In addition to Gazyva, Roche s pipeline of potential hematology medicines includes two antibodydrug conjugates (anti-cd9b [RG596] and anti-cd22 [RG593]), a small molecule antagonist of MDM2 (RG112) and in collaboration with AbbVie, a small molecule BCL-2 inhibitor (RG601/GDC-0199/ABT-199).
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, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissuebased cancer diagnostics, and a frontrunner in diabetes management. Roche s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 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. All trademarks used or mentioned in this release are protected by law. Roche Group Media Relations Phone: +41-61 688 8888 / e-mail: roche.mediarelations@roche.com - Alexander Klauser (Head) - Silvia Dobry - Daniel Grotzky - Štěpán Kráčala