Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data from multiple studies of Venclexta®/Venclyxto® (venetoclax), presented at the 22nd European Hematology Association (EHA) Annual Congress, 22-25 June, in Madrid. Data presented in relapsed or refractory chronic lymphocytic leukaemia (CLL) confirmed the efficacy of Venclexta/Venclyxto with high and durable response rates and a well-tolerated safety profile in this high-risk population, including people with 17p chromosomal deletion who had previously received treatment. Additionally, phase Ib data demonstrated the anti-cancer activity of Venclexta/Venclyxto in acute myeloid leukaemia (AML) and relapsed or refractory multiple myeloma (MM), further supporting the potential of this treatment in a broader range of blood cancers. Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.
“Confirmation that Venclexta/Venclyxto achieves a high response rate in relapsed or refractory chronic lymphocytic leukaemia in people with 17p deletion is very promising, as these patients have a particularly poor prognosis,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are also pleased to see early data highlighting the potential central role of BCL-2 in other difficult-to-treat blood cancers and look forward to validating these results in further studies.”
The safety and efficacy of Venclexta/Venclyxto is being evaluated in a number of clinical studies in patients with CLL, some of which have led to European Medicines Agency (EMA) conditional marketing authorisation (M13-982 and M14-032) of Venclyxto and Food and Drug Administration (FDA) accelerated approval (M13-982) for Venclexta monotherapy in CLL. Data being presented at EHA include:
The safety and efficacy of Venclexta/Venclyxto is also being evaluated in other blood cancers, including AML, an aggressive form of leukaemia that starts in myeloid cells, and MM, a cancer formed from malignant plasma cells.
Venclexta/Venclyxto is a small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in a process called apoptosis (programmed cell death). Overexpression of the BCL-2 protein in CLL has been associated with resistance to certain therapies. It is believed that blocking BCL-2 may restore the signalling system that tells cells, including cancer cells, to self-destruct.
Venclexta/Venclyxto is being co-developed by AbbVie and Roche. Together, the companies are committed to research with Venclexta/Venclyxto , which is currently being evaluated in phase III clinical trials for the treatment of relapsed, refractory and previously untreated CLL, along with studies in several other cancers. Venclexta/Venclyxto is commercialised jointly by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.
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 Venclexta/Venclyxto (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 malignancy, with the development of the investigational haemophilia A treatment emicizumab.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. 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.
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.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty 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 eight years in a row by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 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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