EHA2018: Nye langtidsdata bekrefter at Roches kreftmedisin Gazyvaro®▼ gir overlevelsesgevinst til pasienter med kronisk lymfatisk leukemi sammenlignet med MabThera

● Etter en oppfølgingstid på nesten fem år viser CLL11-studien en 51 prosent risikoreduksjon for sykdomsprogresjon eller død med Gazyvaro (obinutuzumab) sammenlignet med MabThera (rituximab)

● I den endelige analysen ble det observert en overlevelsesgevinst ved bruk av Gazyvaro sammenlignet med MabThera, når begge kombineres med klorambucil

● Disse dataene viser at Gazyvaro fører til en forbedret behandling av pasienter med tidligere ubehandlet KLL med komorbiditeter, sammenlignet med MabThera-basert behandling.

Les Roches internasjonale pressemelding for nærmere informasjon:

Basel, 15 June 2018

New long-term data confirm Roche’s Gazyva/Gazyvaro extends the lives of people with chronic lymphocytic leukaemia compared to MabThera/Rituxan

• After a follow-up time of nearly five years the CLL11 study shows a 51% reduction in the risk of disease progression or death with Gazyva/Gazyvaro compared to MabThera/Rituxan
• The final analysis reports a clinically meaningful overall survival benefit is seen for Gazyva/Gazyvaro compared to MabThera/Rituxan when combined with chlorambucil
• These data highlight the superiority of Gazyva/Gazyvaro-based treatment over MabThera/Rituxan-based treatment for patients with previously untreated CLL with comorbidities

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced data from the final analysis of the CLL11 study evaluating Gazyva®/Gazyvaro® (obinutuzumab)-based treatment in previously untreated chronic lymphocytic leukaemia (CLL) which will be presented during the Presidential Symposium at the 23rd European Hematology Association (EHA) Annual Congress, 14 - 17 June, in Stockholm. After a follow-up of nearly five years, final results showed clinically meaningful improvements with Gazyva/Gazyvaro plus chlorambucil across multiple endpoints, including progression-free survival (PFS) and overall survival (OS), when compared head-to-head with MabThera®/Rituxan® (rituximab) plus chlorambucil. Gazyva/Gazyvaro-based treatment reduced the risk of death by 24% compared to MabThera/Rituxan-based treatment (median OS not reached vs. 73.1 months, HR= 0.76; 95% CI 0.60-0.97; p<0.0245). These new data add to the growing body of evidence for the OS benefit with Gazyva/Gazyvaro in first-line CLL after the previously reported OS benefit with Gazyva/Gazyvaro combined with chlorambucil versus chlorambucil alone.

“We are very pleased that the majority of patients treated with Gazyva/Gazyvaro are still alive after nearly five years of follow-up in the CLL11 study,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “This meaningful survival benefit compared to MabThera/Rituxan-based therapy reinforces that Gazyva/Gazyvaro-based therapy is an important option for people with previously untreated CLL.”

After a median observation time of nearly five years (59.4 months) this final analysis of the CLL11 study demonstrated:

●A reduction in the risk of disease progression or death of 51% for patients treated with Gazyva/Gazyvaro plus chlorambucil versus those treated with MabThera/Rituxan plus chlorambucil (median PFS 28.9 vs. 15.7 months, HR= 0.49; 95% CI 0.41-0.58; p<0.0001).

●A clinically meaningful improvement in OS for patients receiving Gazyva/Gazyvaro plus chlorambucil compared to MabThera/Rituxan plus chlorambucil. At the time of final analysis the median OS in the Gazyva/Gazyvaro plus chlorambucil arm was not yet reached which means that more than half of these patients were still alive after nearly five years. A 24% reduction in the risk of death was observed with Gazyva/Gazyvaro plus chlorambucil treatment (median OS not reached vs. 73.1 months, HR= 0.76; 95% CI 0.60-0.97; p<0.0245).

●A prolonged time to initiation of the next therapy (time to new treatment; TTNT) with Gazyva/Gazyvaro plus chlorambucil (median 56.4 vs. 34.9 months, Gazyva/Gazyvaro plus chlorambucil vs. MabThera/Rituxan plus chlorambucil, HR= 0.58; 95% CI 0.46-0.73; p<0.0001).

●Patients treated with Gazyva/Gazyvaro plus chlorambucil achieved a higher rate of minimal residual disease (MRD) negativity versus those treated with MabThera/Rituxan plus chlorambucil (24% vs. 2% of patients MRD-negative, Gazyva/Gazyvaro plus chlorambucil vs. MabThera/Rituxan plus chlorambucil). Being MRD negative means no cancer can be detected in the blood and or bone marrow using a sensitive test.

●No new or unexpected safety concerns for the combination of Gazyva/Gazyvaro plus chlorambucil.

Gazyva/Gazyvaro is currently approved in more than 90 countries in combination with chlorambucil, for people with previously untreated CLL, based on previously reported data from the CLL11 study.^[1]

About the CLL11 study

CLL11 is a phase III, multicenter, open-label, randomised three-arm study to investigate the safety and efficacy profile of Gazyva/Gazyvaro plus chlorambucil compared to MabThera/Rituxan plus chlorambucil or chlorambucil alone in nearly 800 people with previously untreated CLL and comorbidities. The primary endpoint of the study is PFS with secondary endpoints including response rate, molecular remission rate, OS, TTNT and safety profile. In terms of analysis, the study was divided into three stages:

●Stage 1a compared the addition of Gazyva/Gazyvaro to chlorambucil vs. chlorambucil alone

●Stage 1b compared the addition of MabThera/Rituxan to chlorambucil vs. chlorambucil alone

●Stage 2 compared Gazyva/Gazyvaro plus chlorambucil to MabThera/Rituxan plus chlorambucil

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 is marketed as Gazyvaro in the EU and Switzerland.

Gazyva/Gazyvaro is currently approved in more than 90 countries in combination with chlorambucil for people with previously untreated chronic lymphocytic leukaemia (CLL), in more than 80 countries in combination with bendamustine for people with certain types of previously treated follicular lymphoma and in more than 60 countries in combination with chemotherapy for previously untreated, follicular lymphoma.

Additional combination studies investigating Gazyva/Gazyvaro with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers.

About Chronic Lymphocytic Leukaemia

Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in the Western world.^[2] CLL mainly affects men and the median age at diagnosis is about 70 years.^[3] Worldwide, the incidence of all leukaemias is estimated to be over 350,000 and CLL is estimated to affect around one-third of all people newly diagnosed with leukaemia.^[4]

^{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.}

References

[1] Goede V, et al. Obinutuzumab plus Chlorambucil in Patients with CLL and Coexisting Conditions. NEJM. 2014;370:1101-1110

[2] Union for International Cancer Control. 2014 Review of Cancer Medicines on the WHO List of Essential Medicines: Chronic lymphocytic leukemia [Internet; cited 2018 May]. Available from: http://www.who.int/selection_medicines/committees/expert/20/applications/CLL.pdf?ua=1

[3] SEER Stat Fact Sheets: Chronic Lymphocytic Leukemia (CLL) [Internet; cited 2018 May]. Available from: http://seer.cancer.gov/statfacts/html/clyl.html

[4]Wendtner CM, et al. Chronic lymphocytic leukemia. Onkopedia guidelines 2012 [Internet; cited 2018 May]. Available from: https://www.onkopedia-guidelines.info/en/onkopedia/guidelines/chronic-lymphocytic-leukemia-cll/@@view/html/index.html

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