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Roche (RHHBY) Medicine Gazyvaro Granted Approval For The Therapy Of Patients With Previously Untreated Chronic Lymphocytic Leukemia And Co-Existing Medical Conditions In Switzerland



6/18/2014 9:10:29 AM

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In a head-to-head comparison with standard therapy with MabThera, Gazyvaro in combination with chemotherapy reduces the risk of disease progression or death in CLL patients by more than half.

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Swiss regulatory and supervisory authority (Swissmedic) has granted marketing authorisation for Gazyvaro (GA101, obinutuzumab). It has been approved in combination with chemotherapy with chlorambucil for the therapy of patients with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. As a result of its promising clinical benefits for patients compared with the therapies available to date, Gazyvaro has become the first medicine in the world to be designated as a Breakthrough Therapy by the US health authority FDA.

CLL is one of the most common forms of leukemia (blood cancer) that occurs particularly in older individuals and is also known as "leukemia of the elderly". "Gazyvaro is an important new medicine that offers advantages for CLL patients," explained Professor Markus G. Manz, Director of the Department of Hematology at Zurich University Hospital. "I am delighted that now following its approval by Swissmedic, patients in Switzerland will be able to reap the benefits of this innovation too."

Marketing authorisation for Gazyvaro was granted on the basis of the results from the Phase III study CLL11, which showed that patients treated with Gazyvaro and chlorambucil-based chemotherapy had a 61 percent lower risk of disease progression or death compared with the current standard therapy comprising MabThera and chlorambucil.

About the CLL11 study
The Phase III CLL11 study which led to approval being granted was carried out in close collaboration with the German CLL Study Group (DCLLSG). It is a multicentre, open-label, randomised, three-arm study conducted to investigate the efficacy and safety profile of Gazyvaro plus chlorambucil or MabThera plus chlorambucil in comparison with chlorambucil alone in 781 previously untreated patients with CLL and coexisting medical conditions.

The study showed significant superiority for Gazyvaro in combination with chlorambucil in previously untreated patients with co-existing medical conditions compared with a combination of chlorambucil with MabThera and compared with chlorambucil alone.

• Overall survival of patients can be extended significantly compared to treatment with chlorambucil alone by adding Gazyvaro (median overall survival not yet reached; HR=0.41, p=0.002). It is not yet possible to draw a final comparison with the MabThera combination.

• There was an almost 12-fold increase (37.7% vs. 3.3%) in the number of patients classified as MRD (minimal residual disease) negative, or in whose blood practically no tumour cells could be found after treatment.

• Gazyvaro in combination with chlorambucil almost doubled the time during which newly diagnosed CLL did not worsen compared with the MabThera combination (median PFS: 26.7 vs. 15.2 months; HR=0.39, p<0.001).

• 78.4 percent of patients responded to Gazyvaro in combination with chlorambucil (overall response rate, ORR) compared to 65.1 percent who responded to the MabThera combination.

• One in five of the patients treated with Gazyvaro and chlorambucil achieved a complete response (CR: 20.7 percent vs. 7.0 percent).

• The most common serious adverse effects reported during treatment with Gazyvaro in combination with chlorambucil were infusion-related reactions during the first infusion in 21 percent of patients, a reduced platelet count (thrombocytopenia) in 11 percent and a reduced number of certain white blood cells (neutropenia) in 34 percent, although this did not result in an increased rate of infections in the Gazyvaro group.

The study design of the CLL11 study includes two evaluation stages. Regulatory approval in the USA is based on the data from stage 1, that granted by Swissmedic on stage 2, in which Gazyvaro and MabThera were compared directly with each other in combination with chlorambucil.

About chronic lymphocytic leukemia (CLL)
CLL is one of the most common types of leukemia, albeit one that progresses slowly. Approximately 75,000 people worldwide are diagnosed with chronic lymphocytic leukemia every year. Most cases of CLL (95 percent) begin in the B cells, white blood cells that carry on their surface a protein known as CD20.

About Gazyvaro
Gazyvaro is a new monoclonal antibody that attaches to CD20, a protein found only on the surface of B cells. The antibody attacks targeted cells both directly and together with the body's immune system. Gazyvaro is already marketed as Gazyva in the USA and Australia, and is approved in combination with chlorambucil for patients with previously untreated chronic lymphocytic leukemia (CLL). Gazyvaro was discovered by Roche Glycart AG, now known as Roche Innovation Center Zurich, a part of Roche's Pharma Research and Early Development organisation.

About Roche in hematology
For more than 20 years, Roche has been developing medicines that redefine treatment in hematology. In addition to MabThera and Gazyvaro, Roche also has other candidates for the therapy of leukemia in its development pipeline.

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, hematology, 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.

All trademarks used or mentioned in this release are protected by law.
Roche Group Media Relations
Telephone: +41 61 688 8888 / e-mail: basel.mediaoffice@roche.com
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