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    ROG   CH0012032048

ROCHE HOLDING AG

(ROG)
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Delayed Swiss Exchange  -  11:30 2022-08-18 am EDT
319.95 CHF   +1.04%
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Roche Holding AG Announces New Pivotal Data Demonstrate Clinical Benefit of Glofitamab, A Potential First-In-Class Bispecific Antibody for People with Aggressive Lymphoma

05/27/2022 | 01:00am EDT

Roche announced that new pivotal data on its investigational CD20xCD3 T-cell engaging bispecific antibody, glofitamab, will be presented for the first time at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from 3-7 June and the European Hematology Association (EHA) 2022 Congress from 9-12 June. Data from the phase II NP30179 expansion study demonstrated that, after a median follow-up of more than 12 months, fixed-duration glofitamab (given for a fixed amount of time, and not taken until disease progression) induces durable complete responses (CRs) in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who had received a median of three prior therapies. The pivotal phase II NP30179 expansion study included patients with heavily pre-treated and highly refractory DLBCL, with 58.3% of patients refractory to their initial therapy and about one-third (33.1%) having received prior CAR T-cell therapy.1 After a median follow-up of 12.6 months, 39.4% of patients (n=61/155) achieved a CR (primary efficacy endpoint) and half of them (51.6%; n=80/155) achieved an overall response (the percentage of patients with a partial or complete response; secondary efficacy endpoint), as assessed by an independent review committee. The majority (77.6%) of complete responses were durable and ongoing at 12 months and the median duration of complete response had not yet been reached (not evaluable [16.8 months, not evaluable]). Cytokine release syndrome (CRS) was the most common adverse event occurring in 63.0% of patients. CRS events were predictable, generally low grade (mainly Grade 1 [47.4%] or 2 [11.7%]), occurred at initial doses, and only one patient discontinued glofitamab due to CRS. Incidence of Grade 3+ CRS was low (3.9%), with no Grade 5 events. Data from the NP30179 study have been submitted for approval to the European Medicines Agency (EMA), and submissions to additional health authorities worldwide, including to the U.S. Food and Drug Administration (FDA), are planned this year. Glofitamab is being investigated in several clinical trials and explored in earlier lines of lymphoma treatment. Roche is committed to improving standards of care to enhance the treatment experience and outcomes for people with blood cancers and the scientific data they are sharing at ASCO and EHA from portfolio propels further towards this goal. Roche is investigating its CD20xCD3 T-cell engaging bispecific antibodies glofitamab and mosunetuzumab further as subcutaneous formulations and in additional phase III studies that will expand the understanding of their impact in earlier lines of treatment, with the aim of providing people with different types of lymphomas with robust and durable treatment outcomes. Additionally, the European Commission (EC) recently granted approval of Polivy® (polatuzumab vedotin) in combination with MabThera® (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL), and the EMA’s Committee for Medicinal Products for Human Use recommended mosunetuzumab for approval for patients with R/R follicular lymphoma, who have received at least two prior systemic therapies.


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Financials
Sales 2022 64 249 M 67 424 M 67 424 M
Net income 2022 14 824 M 15 557 M 15 557 M
Net Debt 2022 10 272 M 10 779 M 10 779 M
P/E ratio 2022 17,2x
Yield 2022 3,02%
Capitalization 263 B 276 B 276 B
EV / Sales 2022 4,25x
EV / Sales 2023 4,13x
Nbr of Employees 100 920
Free-Float 89,0%
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Number of Analysts 25
Last Close Price 319,95 CHF
Average target price 374,13 CHF
Spread / Average Target 16,9%
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Managers and Directors
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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