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    ROG   CH0012032048

ROCHE HOLDING AG

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01:00aRoche Announces U.S. FDA approval of Xofluza to treat influenza in children aged five years and older
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Roche Announces Positive Data from Broad Blood Cancer Portfolio At European Hematology Association Annual Meeting

06/10/2022 | 01:00am EDT

Roche announced that it is presenting new long-term follow-up results and subanalyses from clinical trials of its approved therapies, as well as data on investigational medicines from its broad blood cancer portfolio, at the European Hematology Association (EHA) 2022 Congress in Vienna. Data include five-year results from the phase III CLL14 study of fixed-duration Venclexta®/Venclyxto® (venetoclax) plus Gazyva®/Gazyvaro® (obinutuzumab) in previously untreated chronic lymphocytic leukaemia (CLL); the final analysis of the phase III GALLIUM study of Gazyva/Gazyvaro plus chemotherapy in people with previously untreated advanced-stage follicular lymphoma (FL); and subanalyses from the phase III POLARIX study of Polivy® (polatuzumab vedotin) in combination with MabThera®/Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Roche will also present data from its T-cell engaging bispecific antibody development programmes including Lunsumio® (mosunetuzumab) and glofitamab in patients receiving later lines of therapy for non-Hodgkin lymphoma (NHL) and investigational medicines cevostamab and RG6234 in relapsed or refractory (R/R) multiple myeloma (MM). Improving clinical outcomes with effective frontline treatment options: Five-year results of phase III CLL14 study of Venclexta/Venclyxto plus Gazyva/Gazyvaro (Abstract #S148) After a median of 65.4 months following treatment with Venclexta/Venclyxto plus Gazyva/Gazyvaro, results confirm the combination continues to be an effective fixed-duration and chemotherapy-free option for patients with previously untreated CLL and coexisting conditions. The estimated investigator-assessed progression-free survival (PFS) rate at this follow-up was 62.6% with Venclexta/Venclyxto plus Gazyva/Gazyvaro and 27.0% with Gazyva/Gazyvaro plus chlorambucil, and the estimated overall survival (OS) rate was 81.9% versus 77.0% (HR 0.72; 95% CI: 0.48-1.09; p=0.12). In addition, the analysis found that 72.1% of patients in the Venclexta/Venclyxto plus Gazyva/Gazyvaro arm did not require another treatment for CLL in the five years following initial treatment (HR 0.42; 95% CI: 0.31-0.57; p<0.0001). No new safety signals were observed.[1] The CLL14 study is being conducted in cooperation with the German CLL Study Group, headed by Michael Hallek, M.D., University of Cologne. Final analysis of phase III GALLIUM study of Gazyva/Gazyvaro (Abstract #S206): After eight years of follow-up in people with previously untreated FL, a meaningful improvement in PFS was maintained with Gazyva/Gazyvaro plus chemotherapy, confirming its role as a standard of care for first-line treatment. Seven-year investigator-assessed PFS was significantly improved with Gazyva/Gazyvaro plus chemotherapy (63.4%) compared with MabThera/Rituxan plus chemotherapy (55.7%; HR 0.77; 95% CI: 0.64-0.93; p=0.006). This translated into a longer time to next anti-lymphoma treatment. At seven years, 74.1% of patients receiving Gazyva/Gazyvaro plus chemotherapy had not started new anti-lymphoma therapy compared to 65.4% receiving MabThera/Rituxan plus chemotherapy (HR 0.71; 95% CI: 0.58&#150;0.87; p=0.001). The incidence of serious adverse events was 48.9% with Gazyva/Gazyvaro plus chemotherapy and 43.4% with MabThera/Rituxan plus chemotherapy. Subgroup analyses of pivotal phase III POLARIX study(Abstract #P1192): Exploratory subgroup analyses of the phase III POLARIX study of Polivy with R-CHP compared to the current standard of care, MabThera/Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), in people with previously untreated DLBCL further support the potential for Polivy to transform the standard of care for people with this aggressive type of lymphoma. One of the datasets being presented is an analysis of study participants from Asia (China, Hong Kong, Japan, South Korea and Taiwan). Among this subgroup, results showed a significant improvement in PFS with Polivy plus R-CHP versus R-CHOP, reducing the risk of disease progression, relapse or death by 36% (HR 0.64; 95% CI: 0.40-1.03). The safety profile was generally comparable for both regimens. Based on the positive POLARIX results from the overall study population, the European Commission (EC) approved Polivy plus R-CHP in May 2022 for the treatment of adult patients with previously untreated DLBCL.


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Financials
Sales 2022 64 190 M 68 260 M 68 260 M
Net income 2022 14 826 M 15 766 M 15 766 M
Net Debt 2022 10 272 M 10 923 M 10 923 M
P/E ratio 2022 16,7x
Yield 2022 3,11%
Capitalization 256 B 273 B 273 B
EV / Sales 2022 4,16x
EV / Sales 2023 4,03x
Nbr of Employees 100 920
Free-Float 82,4%
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Severin Schwan Chief Executive Officer & Executive Director
Alan Hippe Chief Financial & Information Officer
Christoph Franz Chairman
Levi A. Garraway Chief Medical Officer
Pascale Schmidt Chief Compliance Officer
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