Media Release

Basel, 04 February 2015

Roche's Phase III study of Gazyva/Gazyvaro showed significant benefit in refractory indolent non-Hodgkin's lymphoma

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the Phase III GADOLIN study, which evaluated treatment options for people with indolent non-Hodgkin’s lymphoma (iNHL) who are refractory to MabThera®/Rituxan® (rituximab) treatment. At a pre-planned interim analysis, an independent data monitoring committee determined that the study met its primary endpoint early. The study showed that people lived significantly longer without disease worsening or death (progression-free survival, PFS) when treated with Gazyva (obinutuzumab) plus bendamustine followed by Gazyva alone, compared to bendamustine alone. The study was stopped prior to its protocol-specified final analysis due to the high level of benefit seen in the Gazyva arm compared to the bendamustine arm. There were no unexpected adverse events with Gazyva.

“GADOLIN is the first of our pivotal Phase III studies of Gazyva to be completed in the non-Hodgkin’s lymphoma setting, building on the positive results we have seen in chronic lymphocytic leukemia,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are delighted that this study could be evaluated early due to the strength of its data, which we believe supports Gazyva’s potential in combination with bendamustine for people whose MabThera/Rituxan-based therapy failed to adequately control their disease.”

Data from this pivotal study will be submitted for presentation at an upcoming medical meeting and to the U.S. Food and Drug Administration, European Medicines Agency and other health authorities around the world for approval consideration.

About the GADOLIN study

GADOLIN (NCT01059630; GA04753g) is a Phase III open-label, multicenter, randomized two-arm study evaluating Gazyva plus bendamustine followed by Gazyva alone for up to two years compared to bendamustine alone in 413 patients with indolent non-Hodgkin’s lymphoma whose disease progressed during or following MabThera/Rituxan-based therapy. The primary endpoint of the study is PFS, with secondary endpoints including response rate (RR), best response and overall survival (OS).

About Gazyva/Gazyvaro (obinutuzumab)

Gazyva, marketed as Gazyvaro in the EU and Switzerland, is a monoclonal antibody designed to attach to CD20, a protein found only on the surface of B-cells. It attacks and destroys targeted cells both directly and together with the body's immune system.

Gazyva was discovered by Roche Innovation Center Zurich, formerly 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.

Gazyva/Gazyvaro is currently approved in more than 40 countries in combination with chlorambucil for people with previously untreated chronic lymphocytic leukemia.

Gazyva continues to be investigated in a large clinical program, which includes the head-to-head Phase III GOYA study compared to MabThera/Rituxan plus chemotherapy in first line diffuse large B-cell lymphoma (DLBCL) and the head-to-head Phase III GALLIUM study compared to MabThera/Rituxan plus chemotherapy in first line indolent non-Hodgkin’s lymphoma. Additional combination studies with small molecule biologic modifiers are planned or underway across a range of blood cancers.

About non-Hodgkin’s lymphoma

There are two main types of lymphoma: Hodgkin’s lymphoma and non-Hodgkin’s lymphoma (NHL). NHL has two subsets, aggressive and indolent.

NHL represents approximately 85% of all lymphomas diagnosedi and was responsible for approximately 200,000 annual deaths worldwide in 2012i.

B-lymphocytes are cells that are part of the body’s immune system and help to defend the body against infections. B-cell lymphoma develops when these cells become cancerous and begin to multiply and collect in the lymph nodes or lymphatic tissues such as the spleen.

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 diseases of the blood.

In addition to approved medicines MabThera/Rituxan and Gazyva/Gazyvaro, Roche’s pipeline of investigational hematology medicines includes an anti-CD79b antibody drug conjugate (RG7596/polatuzumab vedotin), a small molecule antagonist of MDM2 (RG7112) and in collaboration with AbbVie, a small molecule BCL-2 inhibitor (venetoclax/RG7601/GDC-0199/ABT-199). Roche’s dedication to developing novel molecules in hematology expands beyond oncology, with the development of the investigational hemophilia A treatment ACE910.

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 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 roche.com.

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i) Globocan (2012) Estimated incidence, mortality and 5-year prevalence: both sexes.
http://globocan.iarc.fr/Pages/fact_sheets_population.aspx (URL accessed 26.01.14).