Roche’s Gazyva/Gazyvaro showed superior progression-free survival compared to MabThera/Rituxan in people with previously untreated follicular lymphoma

• Phase III GALLIUM study met primary endpoint early, as determined by independent data monitoring committee

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the pivotal phase III GALLIUM study in people with previously untreated follicular lymphoma, the most common type of indolent (slow-growing) non-Hodgkin lymphoma (iNHL). The study compared the efficacy and safety of Gazyva®/Gazyvaro® (obinutuzumab) plus chemotherapy (CHOP, CVP or bendamustine) followed by Gazyva/Gazyvaro alone, head-to-head with MabThera®/Rituxan® (rituximab) plus chemotherapy followed by MabThera/Rituxan alone. Results from a pre-planned interim analysis showed that Gazyva/Gazyvaro-based treatment significantly reduced the risk of disease worsening or death (progression-free survival; PFS, as assessed by investigator) compared to MabThera/Rituxan-based treatment. Adverse events with either Gazyva/Gazyvaro or MabThera/Rituxan were consistent with what was seen in previous clinical trials when each was combined with various chemotherapies. Data from the GALLIUM study will be presented at an upcoming medical meeting and submitted to health authorities for approval consideration.

“People with follicular lymphoma continue to need better initial treatment options because their disease is incurable and becomes more difficult to treat with each relapse,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. “GALLIUM is the second study in which Gazyva/Gazyvaro showed superior progression-free survival compared to MabThera/Rituxan, when each was combined with chemotherapy.”

In the first head-to-head comparison of Gazyva/Gazyvaro and MabThera/Rituxan, the CLL11 study in people with previously untreated chronic lymphocytic leukaemia and comorbidities, Gazyva/Gazyvaro plus chlorambucil significantly extended PFS compared to treatment with MabThera/Rituxan plus chlorambucil (median PFS 26.7 months vs. 14.9 months, respectively; HR=0.42; 95% CI, 0.33-0.54; p<0.0001).¹ The most common side effects of Gazyva/Gazyvaro plus chlorambucil were infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhoea.

About the GALLIUM study

GALLIUM (NCT01332968) is a global Phase III open-label, multi-centre, randomised two-arm study examining the efficacy and safety of Gazyva/Gazyvaro plus chemotherapy, as compared to MabThera/Rituxan plus chemotherapy, followed by Gazyva/Gazyvaro or MabThera/Rituxan alone for up to two years. Chemotherapies used were CHOP, CVP or bendamustine as selected by each participating study site. GALLIUM included 1401 patients with previously untreated indolent non-Hodgkin lymphoma (iNHL), of which 1202 patients had follicular lymphoma. The primary endpoint of the study was investigator-assessed PFS in patients with follicular lymphoma, with secondary endpoints including PFS assessed by independent review committee (IRC), PFS in the overall study population (iNHL), response rate (overall response, ORR; and complete response, CR), overall survival (OS), disease-free survival (DFS) and safety. The GALLIUM study is being conducted in cooperation with the German Low Grade Lymphoma Study Group (GLSG; Germany), the East German Study Group Hematology and Oncology (OSHO; Germany) and the National Cancer Research Institute (NCRI; United Kingdom).

About Gazyva/Gazyvaro (obinutuzumab)

Gazyva/Gazyvaro is an engineered monoclonal antibody designed to attach to CD20, a protein expressed on certain B cells, but not on stem cells or plasma cells. Gazyva/Gazyvaro is designed to attack and destroy targeted B-cells both directly and together with the body's immune system. Gazyva/Gazyvaro is currently approved in more than 70 countries in combination with chlorambucil, for people with previously untreated chronic lymphocytic leukaemia. The approval was based on the CLL11 study, showing significant improvements with Gazyva/Gazyvaro plus chlorambucil across multiple clinical endpoints, including PFS, overall response rate (ORR), complete response rate (CR), and minimal residual disease (MRD) when compared head-to-head with MabThera/Rituxan plus chlorambucil. Furthermore, Gazyva was recently approved by the U.S. Food and Drug Administration in combination with bendamustine followed by Gazyva alone for people with follicular lymphoma who did not respond to a MabThera/Rituxan-containing regimen, or whose follicular lymphoma returned after such treatment. The approval was based on the GADOLIN study, showing a significant improvement in progression-free survival with Gazyva/Gazyvaro-based therapy compared to bendamustine alone. Those results have also been submitted to other health authorities around the world for approval consideration and resulted in the recent positive opinion by the EU Committee for Medicinal Products for Human Use for Gazyvaro in combination with bendamustine chemotherapy followed by Gazyvaro maintenance as a new treatment for people with follicular lymphoma who did not respond to, or who progressed during or up to six months after treatment with MabThera or a MabThera-containing regimen. Gazyva is marketed as Gazyvaro in the EU and Switzerland.

Gazyva/Gazyvaro continues to be studied in a large clinical programme, including the phase III GOYA study, comparing Gazyva/Gazyvaro plus CHOP chemotherapy head-to-head with MabThera/Rituxan plus CHOP chemotherapy in first line diffuse large B-cell lymphoma (DLBCL). Additional combination studies investigating Gazyva/Gazyvaro with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are planned or underway across a range of blood cancers.

About follicular lymphoma

Follicular lymphoma is the most common indolent (slow-growing) form of non-Hodgkin lymphoma (NHL), accounting for about one in five cases of NHL² It is considered incurable and relapse is common. It is estimated that more than 75,000 people are diagnosed with follicular lymphoma each year worldwide.³

About Roche in haematology

For more than 20 years, Roche has been developing medicines that redefine treatment in haematology. Today, we are 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 (rituximab), Gazyva/Gazyvaro (obinutuzumab), and VenclextaTM (venetoclax) in collaboration with AbbVie, Roche’s pipeline of investigational haematology medicines includes Tecentriq (atezolizumab), an anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596) and a small molecule antagonist of MDM2 (idasanutlin/RG7388). Roche’s dedication to developing novel molecules in haematology expands beyond oncology, with the development of the investigational haemophilia A treatment emicizumab (ACE910).

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.

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. 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.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine 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. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry seven years in a row by the Dow Jones Sustainability Indices.

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 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.

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References

1. GAZYVA full Prescribing Information. South San Francisco, CA: Genentech USA, Inc.; February 2016.
2. Shankland KR, et al: Non-Hodgkin lymphoma. Lancet 380 (9844): 848-57, 2012.
3. Ferlay J, et al. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available from: http://globocan.iarc.fr (accessed on 19/05/2016).