Press Release : Roche announces data at EHA2021 -2-

VIALE-A [NCT02993523 https://www.globenewswire.com/Tracker?data=gVvdOprlwz7gAZtO440qyL0xxAS1SCXy_h8qZa8qK-pB7R77gfgkUWD877t2ghilGE8WUBshNX1ecnrsad1mAoSEa428QskHMuJo7N33RPaObDTupaNnTcAGtaDEkFOM6T9yMieW0vka54T4Xq1OfKKG1muoTVALmHi8DX-8vfs8HqOhWF10eOLTWE85AysivFU1d1AvCK3OqyVAMXKyU-9wEvXUlTjwkIFWBjhiBzi94BKzvhdJV4fC1DHjrNq_az2R4inQrxfMQ4a_qLR9Bg== ] is a phase III, randomised, double-blind, placebo-controlled multicentre study evaluating the efficacy and safety of Venclexta(R)/Venclyxto(R) (venetoclax) plus azacitidine, a hypomethylating agent, compared to placebo with azacitidine, in 431 people with previously untreated acute myeloid leukaemia who are ineligible for intensive chemotherapy. Two-thirds of patients (n=286) received 400 mg Venclexta/Venclyxto daily, in combination with azacitidine, and the remaining patients (n=145) received placebo tablets in combination with azacitidine. Patients enrolled in the study had a range of mutational subtypes, including IDH1/2 and FLT3. VIALE-A met its primary and key secondary endpoints.

About Venclexta/Venclyxto

Venclexta(R)/Venclyxto(R) (venetoclax) is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumours, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta/Venclyxto blocks the BCL-2 protein and works to restore the process of apoptosis.

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 US and commercialised by AbbVie outside of the US. Together, the companies are committed to research with Venclexta/Venclyxto, which is currently being studied in clinical trials across several types of blood cancers.

In the US, Venclexta has been granted five Breakthrough Therapy Designations by the U.S. Food and Drug Administration: one for previously untreated chronic lymphocytic leukaemia (CLL), two for relapsed or refractory CLL and two for previously untreated acute myeloid leukaemia.

About Roche in haematology

Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera(R)/Rituxan(R) (rituximab), Gazyva(R)/Gazyvaro(R) (obinutuzumab), Polivy(R) (polatuzumab vedotin), Venclexta(R)/Venclyxto(R) (venetoclax) in collaboration with AbbVie, and Hemlibra(R) (emicizumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab and mosunetuzumab, targeting both CD20 and CD3, and cevostamab, targeting FcRH5 and CD3; Tecentriq(R) (atezolizumab), a monoclonal antibody designed to bind with PD-L1; and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

About Roche

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, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.

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. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.

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. More than 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. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 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.

All trademarks used or mentioned in this release are protected by law.

References

[1] Al-Sawaf O, et al. Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukaemia: 4-year follow-up analysis of the randomised CLL14 study. Presented at: European Hematology Association Virtual Congress; 2021 Jun 9-17. Abstract #S146.

[2] Wu JQ, et al. Impact of unfavorable genetics on minimal residual disease (MRD) response to venetoclax + rituximab retreatment in relapsed or refractory chronic lymphocytic leukaemia (R/R CLL): phase III MURANO substudy. Presented at: European Hematology Association Virtual Congress; 2021 Jun 9-17. Abstract #EP599.

[3] Pratz KW, et al. Measurable residual disease response in acute myeloid leukaemia treated with venetoclax and azacitidine. Presented at: European Hematology Association Virtual Congress; 2021 Jun 9-17. Abstract #S137.

[4] Giudice ID, et al. Minimal Residual Disease in Chronic Lymphocytic Leukemia: A New Goal? Front Oncol. 2019;9:689.

[5] Fischer K, et al.Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions. N Engl J Med. 2019; 380:2225-2236

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June 11, 2021 01:03 ET (05:03 GMT)