Roche announces EU approval of Venclyxto plus MabThera for people with previously treated chronic lymphocytic leukaemia

  • Approval is based on randomised phase III MURANO study showing that fixed duration of treatment with Venclyxto plus MabThera is well tolerated and reduced risk of disease progression or death by 83% compared to a current standard of care
  • New combination provides a chemotherapy-free option for treating people with chronic lymphocytic leukaemia whose disease has returned after previous treatment

Roche today announced that the European Commission has approved Venclyxto (venetoclax) in combination with MabThera (rituximab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.

“There are approximately 30,000 people living with chronic lymphocytic leukaemia in Europe, an incurable blood cancer that becomes harder to treat with each relapse,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are pleased that, thanks to this approval, Venclyxto plus MabThera will provide a new chemotherapy-free option for people with previously treated chronic lymphocytic leukaemia, helping them to live longer without their disease progressing compared to a standard-of-care therapy.”

This approval is based on results from the randomised phase III MURANO study which showed that a fixed duration of treatment with Venclyxto plus MabThera significantly reduced the risk of disease progression or death (progression-free survival [PFS] as assessed by investigators [INV], primary endpoint of the study) by 83% compared with bendamustine plus MabThera (BR), a current standard of care (HR=0.17; 95% CI 0.11-0.25; p<0.0001). PFS assessed by independent review committee was consistent. In addition, minimal residual disease (MRD)-negativity in peripheral blood at the end of combination treatment was 62.4% with Venclyxto plus MabThera compared to 13.3% with BR. Being MRD-negative means no cancer can be detected in the blood and or bone marrow using a sensitive test. In Europe, MRD is used as an indicator of a patient achieving longer endpoints such as PFS and overall survival. The most commonly observed side effects of Venclyxto plus MabThera included low white blood cell count (neutropenia), diarrhoea and upper respiratory tract infection.

Venclyxto was previously granted conditional marketing authorisation in the EU in December 2016 as a single agent for the treatment of CLL in the presence of 17p deletion or TP53 mutation in people who are unsuitable for or have failed a B-cell receptor pathway inhibitor. Today’s EU approval follows the US Food and Drug Administration approval in June 2018 of Venclexta in combination with Rituxan for the treatment of people with CLL or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy. Additional submissions of the MURANO data to health authorities around the world are ongoing.

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, under the brand name Venclexta, and commercialised by AbbVie outside of the United States.

About the MURANO Study

MURANO (NCT02005471) is a phase III open-label, international, multicentre, randomised study evaluating the efficacy and safety of fixed duration Venclexta/Venclyxto (venetoclax) in combination with MabThera/Rituxan (rituximab) compared to standard of care bendamustine in combination with MabThera/Rituxan (BR) in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL). Patients on the Venclexta/Venclyxto plus MabThera/Rituxan arm received six cycles of Venclexta/Venclyxto plus MabThera/Rituxan followed by Venclexta/Venclyxto monotherapy for up to two years total. Patients on the BR arm received six cycles of BR. The study included 389 patients with CLL who had been previously treated with at least one line of therapy. Patients were randomly assigned in a 1:1 ratio to receive either Venclexta/Venclyxto plus MabThera/Rituxan or BR. The primary endpoint of the study was progression-free survival (PFS) as assessed by investigator (INV). Secondary endpoints included overall survival (OS), overall response rate (ORR), complete response rate (with or without complete blood count recovery, CR/CRi), minimal residual disease (MRD) and safety.

*Data at median follow-up of 24 months

The most common adverse reactions (≥20%) of any grade in patients receiving Venclyxto in the combination study with MabThera were neutropenia, diarrhoea, and upper respiratory tract infection. Death occurred in 11% of people who received Venclexta/Venclyxto plus MabThera/Rituxan compared to 16% for BR.

About Venclexta/Venclyxto (venetoclax)

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

In the United States, Venclexta has been granted four Breakthrough Therapy Designations by the FDA: in combination with Rituxan for people with relapsed or refractory chronic lymphocytic leukaemia (CLL); as a monotherapy for people with relapsed or refractory CLL with 17p deletion; in combination with hypomethylating agents (azacitidine or decitabine) for people with untreated acute myeloid leukaemia (AML) ineligible for intensive chemotherapy; and in combination with low-dose cytarabine for people with untreated AML ineligible for intensive chemotherapy.

Venclexta/Venclyxto is approved in more than 50 countries. Roche and AbbVie are currently working with regulatory agencies around the world to bring this medicine to additional eligible patients in need.

About Chronic Lymphocytic Leukaemia

Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in the Western world.[1]
CLL mainly affects men and the median age at diagnosis is about 70 years.[2] In Europe, the incidence of all leukaemias is estimated to be almost 95,000[3] and CLL is estimated to affect around one-third of all people newly diagnosed with leukaemia.[1]

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 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 Hemlibra (emicizumab), a bispecific monoclonal antibody for the treatment of haemophilia A.


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