GlobeNewswire by notified

Roche to present new pivotal data at ASH 2021 from broad and comprehensive portfolio, challenging treatment standards for people with blood disorders

Share
  • Phase III POLARIX trial showed Polivy plus R-CHP was the first treatment in two decades to significantly improve outcomes in newly diagnosed diffuse large B-cell lymphoma (DLBCL) versus the standard of care1
  • Pivotal data on mosunetuzumab, a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, showed high response rates in relapsed or refractory follicular lymphoma (FL)2
  • HAVEN 6 phase III interim data demonstrated Hemlibra’sfavourable safety and efficacy profile in people with moderate or mild haemophilia A3


Basel, 23 November 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its extensive haematology portfolio will be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition from 11-14 December 2021. Roche molecules will be featured in more than 90 abstracts, including 17 oral presentations, showcasing new immunotherapies, unique treatment combinations, the application of novel endpoints, and fixed-duration regimens.

Results from three pivotal studies will be featured:

  • First presentation of efficacy and safety data from the phase III POLARIX study as a late-breaking abstract and in the ASH press programme. POLARIX met its primary endpoint of improving progression-free survival, showing Polivy® (polatuzumab vedotin) plus MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin, and prednisone (R-CHP) reduced the likelihood of disease worsening or death, versus the standard-of-care, MabThera/Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), for people with newly diagnosed diffuse large B-cell lymphoma (DLBCL). The safety profile was comparable for Polivy plus R-CHP versus R-CHOP.1 POLARIX is being conducted in collaboration with The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC).
  • Pivotal results from the phase I/II GO29781 study, presented for the first time and featured in the ASH press programme, showing mosunetuzumab, a CD20xCD3 T-cell engaging bispecific antibody immunotherapy, achieved high response rates with a manageable safety profile. These data suggest that it could be a new treatment option for people with relapsed or refractory follicular lymphoma (FL) who have received two or more prior therapies.2 FL is the most common indolent (slow growing) form of non-Hodgkin lymphoma, a type of blood cancer, which often returns after initial therapy.4
  • Interim data from the phase III HAVEN 6 study, which demonstrated the favourable safety and efficacy profile of Hemlibra® (emicizumab) in people with moderate or mild haemophilia A without factor VIII inhibitors.3 This patient population has historically not used prophylactic (preventative) treatments, likely due to delayed or missed diagnosis and a lack of treatments and treatment guidelines, meaning these patients have a significant unmet clinical need.5, 6

“For 20 years, we have remained committed to deepening our understanding of many benign and malignant blood disorders in order to better meet the urgent needs of patients with these diseases,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Our data at ASH reinforce our conviction that following the science and developing versatile treatment approaches leads to improved outcomes for patients in increasingly meaningful ways.”

Data presented at ASH by Roche span numerous blood diseases, including lymphoma, leukaemia, multiple myeloma and haemophilia. Additional data to be presented include updated results for three T-cell engaging bispecific antibody immunotherapies: glofitamab and mosunetuzumab, targeting CD20 and CD3; and cevostamab, targeting FcRH5 and CD3.

Further information on the key abstracts featuring Roche medicines presented can be found in the table below.

Roche will be hosting a Live Media Event titled: ‘Redefining treatment standards to improve outcomes for patients with blood disorders’ on Wednesday 15 December, offering an exclusive opportunity to hear from experts about the pivotal data being presented. Register here to access the Roche Haematology Newsroom, available from Friday 26 November, where you’ll be able to attend the Live Media Event and find materials to further explain and provide context to Roche’s malignant and non-malignant data.

Follow Roche on Twitter via @Roche and LinkedIn and keep up to date with ASH Annual Meeting news and updates by using the hashtag #ASH21.

MedicineAbstract titleAbstract number/presentation details
PolivyThe POLARIX Study: Polatuzumab Vedotin with Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (pola-R-CHP) Versus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) Therapy in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma#LBA-1 oral presentation
Session: Late-Breaking Abstracts
Tuesday 14 December, 2021
09:00-10:30 ET/15:00-16:30 CET
Mosunetuzumab







Mosunetuzumab Monotherapy Is an Effective and Well-Tolerated Treatment Option for Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Who Have Received ≥2 Prior Lines of Therapy: Pivotal Results from a Phase I/II Study#127 oral presentation
Session: 623
Saturday 11 December, 2021
12:00-13:30 ET/18:00-19:30 CET
Mosunetuzumab Plus Polatuzumab Vedotin Has Promising Efficacy and a Favorable Safety Profile in Patients with Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma: Updated Results from a Phase Ib/II Study#533 oral presentation
Session: 627
Sunday 12 December, 2021
16:30-18:00 ET/22:30-00:00 CET
Mosunetuzumab in Combination with Lenalidomide Has a Manageable Safety Profile and Encouraging Activity in Patients with Relapsed/Refractory Follicular Lymphoma: Initial Results from a Phase Ib Study#129 oral presentation
Session: 623
Saturday 11 December, 2021
12:00-13:30 ET/18:00-19:30 CET
Subcutaneous (SC) Administration of Mosunetuzumab with Cycle 1 Step-Up Dosing Is Tolerable and Active in Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphomas (R/R B-NHL): Initial Results from a Phase I/II Study#3573 poster presentation
Session: 626
Monday 13 December, 2021
18:00-20:00 ET/00:00-02:00 CET
Glofitamab









Glofitamab Step-Up Dosing Induces High Response Rates in Patients (pts) With Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL), Most of Whom Had Failed Prior Bruton’s Tyrosine Kinase Inhibitor (BTKi) Therapy#130 oral presentation
Session: 623
Saturday 11 December, 2021
12:00-13:30 ET/18:00-00:00 CET
Glofitamab (Glofit) in Combination with Polatuzumab Vedotin (Pola): Phase Ib/II Preliminary Data Support Manageable Safety and Encouraging Efficacy in Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)#525 oral presentation
Session: 626
Sunday 12 December, 2021
16:30-18:00 ET/22:30-00:00 CET
Glofitamab As Monotherapy and in Combination with Obinutuzumab Induces High Complete Response Rates in Patients (pts) with Multiple Relapsed or Refractory (R/R) Follicular Lymphoma (FL)#128 oral presentation
Session: 623
Saturday 11 December, 2021
12:00-13:30 ET/18:00-00:00 CET

Glofitamab Monotherapy Provides Durable Responses After Fixed-Length Dosing in Relapsed/Refractory (R/R) non-Hodgkin Lymphoma (NHL) Patients (pts)#2478 poster presentation
Session: 626
Sunday 12 December, 2021
18:00-20:00 ET/00:00-02:00 CET
Glofitamab Plus R-CHOP Induces High Response Rates With Minimal Cytokine Release Syndrome (CRS) in Patients (pts) with Relapsed/Refractory (R/R) Non-Hodgkin Lymphoma (NHL) and Previously Untreated (1L) Diffuse Large B-Cell Lymphoma (DLBCL): Preliminary Results From a Dose-Escalation and Safety Run-in Phase Ib Study#2479 poster presentation
Session: 626
Sunday 12 December, 2021
18:00-20:00 ET/00:00-02:00 CET
Cevostamab

Cevostamab Monotherapy Continues to Show Clinically Meaningful Activity and Manageable Safety in Patients with Heavily Pre-Treated Relapsed/Refractory Multiple Myeloma (RRMM): Updated Results from an Ongoing Phase I Study#157 oral presentation
Session: 653
Saturday 11 December, 2021
12:00-13:30 ET/18:00-19:30 CET
Gazyva/Gazyvaro

Obinutuzumab Short Duration Infusion Is Preferred by Healthcare Providers and Has Minimal Impact on Patient-Reported Symptoms Among Patients with Untreated, Advanced Follicular Lymphoma#1345 poster presentation
Session: 623
Saturday 11 December, 2021
17:30-19:30 ET/23:30-01:30 CET
Venclexta/Venclyxto





Molecular Responses Are Observed across Mutational Spectrum in Treatment-Naïve Higher-Risk Myelodysplastic Syndrome Patients Treated with Venetoclax Plus Azacitidine#241 oral presentation
Session: 637
Saturday 11 December, 2021
14:00-15:30 ET/20:00-21:30 CET

Outcomes in Patients with Poor-Risk Cytogenetics with or without TP53 Mutations Treated with Venetoclax Combined with Hypomethylating Agents#224 oral presentation
Session: 617
Saturday 11 December, 2021
14:00-15:30 ET/20:00-21:30 CET

Chronic Lymphocytic Leukemia (CLL) Clonal Growth Rate Is Slower Following Venetoclax-Rituximab (VenR): Results from a Minimal Residual Disease (MRD) Model from the Randomized Phase 3 Murano Trial#1551 poster presentation
Session: 642
Saturday 11 December, 2021
17:30-19:30 ET/23:30-01:30 CET

Hemlibra



Emicizumab Prophylaxis in Persons with Mild or Moderate Hemophilia A: Results from the Interim Analysis of the HAVEN 6 Study#343 oral presentation
Session: 322
Sunday 12 December, 2021
09:30-11:00 ET/15:30-17:00 CET
Evaluation of the Safety of Emicizumab Prophylaxis in Persons with Hemophilia A: An Updated Summary of Thrombotic Events and Thrombotic Microangiopathies#3186 poster presentation
Session: 322
Monday 13 December, 2021
18:00-20:00 ET/00:00-02:00 CET

Crovalimab





Two Currently Recruiting Randomized Phase III Trials: COMMODORE 1 and 2 Evaluating Crovalimab vs Eculizumab in Patients With Paroxysmal Nocturnal Hemoglobinuria with or without Current Anti–Complement Therapy#4313 publication only

Trial in Progress: The Randomized, Double-Blind, Placebo-Controlled Phase Ib CROSSWALK-a Trial Evaluating the Safety of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOEs) in Patients with Sickle Cell Disease (SCD)#3108 poster presentation
Session: 114
Monday 13 December, 2021
18:00-20:00 ET/ 00:00-02:00 CET
Trial in Progress: The Randomized, Double-Blind, Placebo-Controlled Phase IIa CROSSWALK-c Trial Evaluating the Efficacy of Crovalimab As Adjunct Treatment in the Prevention of Vaso-Occlusive Episodes (VOEs) in Patients with Sickle Cell Disease (SCD)#3111 poster presentation
Session: 114
Monday 13 December, 2021
18:00-20:00 ET/00:00-02:00 CET


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®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, and Hemlibra® (emicizumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab and mosunetuzumab, targeting both CD20 and CD3, and cevostamab, targeting both FcRH5 and CD3; Tecentriq® (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, the company 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 thirteenth consecutive year, Roche has been recognised as one of the most sustainable companies in the pharmaceutical 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] Tilly H, et al. The POLARIX Study: Polatuzumab Vedotin with Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (pola-R-CHP) Versus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) Therapy in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma. Presentation at: ASH Annual Meeting and Exposition; 2021 Dec 11-14 Abstract #LBA-1.
[2] Budde E, et al. Mosunetuzumab Monotherapy is an Effective and Well-Tolerated Treatment Option for Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) who have Received ≥2 Prior Lines of Therapy: Pivotal Results from a Phase I/II Study. Presentation at ASH Annual Meeting and Exposition; 2021 Dec 11-14 Abstract #127.
[3] Negrier C, et al. Emicizumab Prophylaxis in Persons with Mild or Moderate Hemophilia A: Results from the Interim Analysis of the HAVEN 6 Study. Presentation at ASH Annual Meeting and Exposition; 2021 Dec 11-14 Abstract #343.
[4] Fowler NH. Role of Maintenance Rituximab (Rituxan) Therapy In the Treatment of Follicular Lymphoma. Pharmacy and Therapeutics; 2011; 36:590-598.
[5] Walsh C et al. Identified unmet needs and proposed solutions in mild-to-moderate haemophilia: A summary of opinions from a roundtable of haemophilia experts. Haemophilia. 2021 February 01; 27(S1):25-32.
[6] Nissen F, et al. An Insight into clinical outcomes in mild, moderate, and severe hemophilia A (HA): A preliminary analysis of the CHESS II study. International Society on Thrombosis and Haemostasis (ISTH) 2020 Congress, 12-14 July, 2020; Abstract OC 09.3.


Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Dr. Nicolas Dunant
Phone: +41 61 687 05 17
Sileia Urech
Phone: +41 79 935 81 48

Dr. Barbara von Schnurbein
Phone: +41 61 687 89 67
Karsten Kleine
Phone: +41 61 682 28 31

Nina Mählitz
Phone: +41 79 327 54 74
Nathalie Meetz
Phone: +41 61 687 43 05


Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

AMG Advanced Metallurgical Group N.V. Announces AMG Brazil Mine Site has Reached Over 1,000 Days Without a Lost Time Incident1.12.2021 22:00:00 CET | Press release

Amsterdam, 1December 2021--- AMG Advanced Metallurgical Group N.V. ("AMG", EURONEXT AMSTERDAM: "AMG") is pleased to announce that the AMG Brazil Mine Site has reached over 1,000 days without a Lost Time Incident. Dr. Heinz Schimmelbusch, Chairman of the Management Board and CEO, said, “At AMG, the health and safety of our employees is the number one value. “Zero incidents” for an extended period of time is an extraordinary achievement. This incredible milestone was only possible because of each employee’s discipled attitude and proactive responsibility for creating a safe working environment.” “AMG Brazil has a certified HSE management system that is mature, robust, well developed, and efficient at preventing incidents by fostering identification and mitigation of risks and hazards as we constantly train our workforce to perform its duties safely. The system alone would never achieve such a result without our workers’ preemptive behavior and commitment to care for themselves and their

Sophi.io Wins at WAN-IFRA Digital Media Awards Worldwide 20211.12.2021 17:51:16 CET | Press release

Sophi Dynamic Paywall wins global award for Best Paid Media Strategy TORONTO, Dec. 01, 2021 (GLOBE NEWSWIRE) -- Sophi.io, The Globe and Mail’s artificial intelligence-based automation, optimization and prediction engine, won WAN-IFRA’s 2021 Digital Media Awards Worldwide award in the Best Paid Media Strategy category for Sophi Dynamic Paywall, its real-time, personalized paywall engine that analyses both content characteristics and user behaviour to determine when to ask a reader for money or an email address, and when to leave them alone. The judges unanimously selected Sophi Dynamic Paywall as the winner, with one judge commenting: “What Globe and Mail did is state of the art and what I appreciate most is that they permanently tested against the old paywall so those results are really, really sustainable.” The World Association of News Publishers (WAN-IFRA)’s Digital Media Awards Worldwide is the news media industry’s global digital media competition. The worldwide winners are select

Wolters Kluwer completes divestment U.S. legal education business1.12.2021 17:35:00 CET | Press release

Wolters Kluwer completes divestment U.S. legal education business December 1, 2021 — Wolters Kluwer today announces that it has completed the divestment of its U.S. legal education business to Transom Capital Group. As previously announced on September 27, Wolters Kluwer intends to deploy the post-tax proceeds towards additional share repurchases in order to mitigate the expected dilution to adjusted earnings per share from the sale. To this end, Wolters Kluwer has now granted a mandate to a third-party to execute up to €60 million in share buybacks on our behalf in the remainder of this year (the period starting December 2, 2021, up to and including December 29, 2021). Including this mandate, when completed, total share repurchases will reach €410 million in 2021. This mandate is governed by the limits of relevant laws and regulations (in particular Regulation (EU) 596/2014) and Wolters Kluwer’s Articles of Association. Repurchased shares are added to and held as treasury shares and a

HMNC Brain Health to Participate in the H.C. Wainwright 2nd Annual Psychedelics Conference1.12.2021 16:37:31 CET | Press release

MUNICH, Germany, Dec. 01, 2021 (GLOBE NEWSWIRE) -- HMNC Brain Health (“HMNC” or the “company”), a clinical stage biopharma company pioneering the development of personalized therapies powered by predictive companion diagnostics, announced today that Chief Executive Officer, Benedikt von Braunmühl, Chief Clinical Development Officer, Dr. Hans Eriksson and Head of Operations, Dr. Maximilian Döbler will present at H.C. Wainwright’s 2nd Annual Psychedelics Conference on Monday, December 6th, 2021. In addition, Dr. Eriksson will participate in the ‘Future of Mental Healthcare’ panel at 2:30 p.m. Eastern Time. To attend, please register here. HMNC Brain Health’s virtual presentation will be available beginning Monday, December 6th at 7:00 a.m. Eastern Time and is accessible through the following webcast link: https://journey.ct.events/view/d77f2d7d-bff2-4d9a-8e89-620a24d1f35a. A webcast of the presentation will be available on the HMNC Brain Health Website for 90 days through the above webca

4TEEN4 Pharmaceuticals Selects AGC Biologics to Manufacture Procizumab1.12.2021 15:03:00 CET | Press release

AGC Biologics to produce Procizumab for early and late clinical phases at company’s Chiba and Copenhagen facilities Seattle, Dec. 01, 2021 (GLOBE NEWSWIRE) -- AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced a new partnership with 4TEEN4 Pharmaceuticals GmbH (“4TEEN4”) to manufacture and commercialize Procizumab. The first-in-class monoclonal antibody Procizumab offers a new approach for the treatment of life-threatening diseases related to acute circulatory failure. Under the terms of the agreement, the companies will collaborate to transfer and optimize the manufacturing process for Procizumab. AGC Biologics will manufacture the clinical trial materials at its site in Chiba and transfer to its Copenhagen facility for all late phase activities including commercialization, to support early and late clinical phases and launch readiness of 4TEEN4’s monoclonal antibody. “We look forward to partnering with 4TEEN4

Kalmar’s proven straddle carrier technology to enhance operational capabilities at Kingston Freeport Terminal, Jamaica1.12.2021 15:00:00 CET | Press release

CARGOTEC CORPORATION, PRESS RELEASE, 1 DECEMBER 2021 AT 4 PM (EET) Kalmar, part of Cargotec, has signed a contract to supply the Kingston Freeport Terminal Limited (KFTL) with four diesel-electric straddle carriers for use at their terminal in Kingston, Jamaica. The order was booked in Cargotec's 2021 Q4 order intake with delivery scheduled to be completed during Q3 2022. KFTL is a strategic transhipment hub in the Caribbean, located at the exit of the Panama Canal and the crossroads of the North/South and East/West lines. The terminal was established in 2015, and it is part of Terminal Link, a joint venture between The CMA CGM Group, a world leader in shipping and logistics, and China Merchants Port (CMP). The four Kalmar Straddle Carriers are part of a progressive fleet renewal strategy geared to improve performance and reliability in the terminal's operation. KFTL’s equipment fleet already includes Kalmar straddle carriers, reachstackers, empty container handlers and terminal tracto

Sinch carries out second part of the directed new share issue of approximately 40 million shares announced on 30 September 20211.12.2021 14:50:00 CET | Press release

NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, JAPAN, AUSTRALIA, SOUTH AFRICA, NEW ZEALAND, HONG KONG, SINGAPORE OR ANY OTHER JURISDICTION IN WHICH THE RELEASE, DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE MAY BE UNLAWFUL, WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES Stockholm, Sweden – December 1, 2021 - Sinch AB (publ) (“Sinch” or the “Company”) carries out a directed new share issue through the issuance of 21 million new shares for a total consideration of approximately SEK 3,469 million. The new share issue constitutes the second part of the SEK 6.6 billion new share issue of in total 40,077,841 shares (the “Shares”) announced on 30 September 2021, the proceeds of which are used to partially fund the acquisition of Pathwire. The subscribers consisted of institutional investors, among others the Canada Pension Plan Investment Board (“CPP Investments”), Temasek, SeaTown Master Fund (“SeaTown”), and SB Northstar LP,