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Tuesday 11 May, 2021

F. Hoffmann-La Roche Ltd

Roche to present data from one of the most comprehensive oncology portfolios at the 2021 ASCO Annual Meeting showcasing advancements for people living with cancer

Roche to present data from one of the most comprehensive oncology portfolios at the 2021 ASCO Annual Meeting showcasing advancements for people living with cancer
  • Data from the first positive phase III study of a cancer immunotherapy in early, resected lung cancer
  • Studies in personalised healthcare exploring tumour agnostic treatments that demonstrate the impact of coupling biomarker testing with targeted therapies to develop individualised treatment plans
  • New data , and drug combination strategies for the treatment of lymphoma from the largest haematology portfolio in industry

Basel, 11 May 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from clinical trials of 19 approved and investigational medicines across 20 cancer types will be presented at the 2021 ASCO Annual Meeting, which will be held 4-8 June, 2021. A total of 132 abstracts that include a Roche medicine will be presented at this year's meeting. These data advance oncology by showing the importance of making patient-centric treatment decisions and providing tailored medical care based on specific cancer types.

“We will be presenting data from across our diverse oncology portfolio that has the potential to help more people living with many types of cancers,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are particularly excited about our compelling immunotherapy data in lung cancer, which may provide new hope for patients with earlier stage disease.”

Focusing on earlier treatment and targeted lung cancer care
Positive results from the phase III IMpower010 study will be presented that show Tecentriq® (atezolizumab) improved disease-free survival (DFS) in people with resectable early-stage non-small cell lung cancer (NSCLC) compared to best supportive care - a first in cancer immunotherapy. This advance is significant, as half of all people with early stage lung cancer today still experience a recurrence following surgery; therefore, treating lung cancer early, before it has spread, can provide the best opportunity for a cure. Additionally, updated data for Gavreto® (pralsetinib) in patients with advanced RET fusion-positive NSCLC, including in patients who are treatment naïve, will be reported. These data highlight the need for early RET fusion-positive testing to identify candidates who may benefit from treatment with Gavreto.

Exploring personalised cancer care for more patients
Roche will present several studies that take tumour-agnostic approaches to clinical development, and in breast cancer, that may benefit people with rare and common tumours alike. These studies bring together       next-generation sequencing, targeted therapies and patient-centric clinical trial design that show how personalised treatment plans are helping to evolve the way people are treated. The phase II ALPHA-T study, made possible through a collaboration with Foundation Medicine and Science37, is pioneering a decentralised approach to clinical trial design which enables patients to participate from their own homes while remaining under the care of their oncologist. The phase II TAPISTRY study, a platform umbrella trial, will pair patients with immunotherapy, targeted therapy or treatment combinations based on distinct tumor biology characteristics. The similarly designed phase II MyTACTIC study is enrolling a diverse population of patients to direct them to appropriately targeted treatments based on the results of comprehensive genomic profiling.

With our research we are contributing to the body of evidence in hormone receptor (HR)-positive breast cancer, the most prevalent type of all breast cancers. For giredestrant, a third generation oral selective oestrogen receptor degrader (SERD), we will present data further supporting the tolerable safety profile and single agent clinical activity, as well as pharmacodynamics data from studies in HR-positive early and metastatic breast cancer.

Defining new solutions for patients with difficult-to-treat blood cancer
New and updated data in non-Hodgkin lymphoma (NHL) will be shared, including data from the T-cell engaging CD20xCD3 bispecific antibody development programme. Glofitamab and mosunetuzumab are both T-cell engaging CD20xCD3 bispecific antibodies that are being studied as single agents or in combination with other Roche therapies. Together, they may offer a new immunotherapy based approach to tackle a range of blood cancers. In addition, data exploring novel combinations with mosunetuzumab and Polivy® (polatuzumab vedotin), an antibody drug conjugate, will also be featured. These data demonstrate how Roche continues to seek new solutions for people living with a range of malignant blood disorders, where treatment options are still limited and both relapse and treatment resistance are common.

Furthermore, Roche’s data showcase a commitment to health equity through medicine delivery approaches that reduce treatment time and cost, trial designs that help remove barriers to clinical trial participation, pioneering cancer immunotherapy to improve outcomes for earlier disease stages, and a focus on inclusivity through developing tumour-specific therapies and therapy combinations based on specific characteristics of each person’s disease.

Roche will be launching an Oncology Newsroom for journalists to access exclusive materials sharing insights into Roche’s latest data, vision and strategy to pursue and advance scientific progress in order to improve the lives of people living with cancer. The newsroom will be available on Tuesday 1 June, and is open to journalists from outside the United States. To access the newsroom, please register via this link: https://oncologyresearchmedia.roche.com.

Keep up to date with ASCO news and updates by using the hashtag #ASCO21 and follow Roche on Twitter via @Roche and LinkedIn.

Overview of key presentations featuring Roche medicines

Medicine Abstract title Abstract number
Lung cancer
Alecensa Final OS analysis from the phase III J-ALEX study of alectinib (ALC) versus crizotinib (CRZ) in Japanese ALK-inhibitor naïve ALK-positive non-small cell lung cancer (ALK+ NSCLC). 9022
Gavreto Safety and efficacy of pralsetinib in patients with advanced RET fusion-positive non-small cell lung cancer: Update from the ARROW trial. 9089
Tecentriq IMpower010: Primary results of a phase III global study of atezolizumab versus best supportive care after adjuvant chemotherapy in resected stage IB-IIIA non-small cell lung cancer (NSCLC). 8500
Tecentriq Artificial intelligence (AI)–powered pathologic response (PathR) assessment of resection specimens after neoadjuvant atezolizumab in patients with non-small cell lung cancer: Results from the LCMC3 study. 106
Tecentriq Pooled analyses of immune-related adverse events (irAEs) and efficacy from the phase 3 trials IMpower130, IMpower132, and IMpower150. 9002
Tecentriq CONTACT-01: A phase III, randomised study of atezolizumab plus cabozantinib versus docetaxel in patients with metastatic non-small cell lung cancer (mNSCLC) previously treated with PD-L1/PD-1 inhibitors and platinum-containing chemotherapy. TPS9134
Tecentriq Clinicogenomic real-world data analysis of patients (pts) with KRAS G12C-mutant advanced non-small cell lung cancer (aNSCLC) from the natural history cohort of the Blood First Assay Screening Trial (BFAST). 9023
Tecentriq Real-world treatment patterns in stages IA-IIIB non-small cell lung cancer. e20528
Blood cancer
Gazyva

 
Obinutuzumab short-duration infusion (SDI) in previously untreated advanced follicular lymphoma: Results from the end of induction analysis of the phase IV GAZELLE study. 7545
Glofitamab Glofitamab step-up dosing (SUD): Complete response rates in updated efficacy data in heavily pretreated relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL) patients (pts).

 
7519
Mosunetuzumab Promising tolerability and efficacy results from dose-escalation in an ongoing phase Ib/II study of mosunetuzumab (M) with polatuzumab vedotin (Pola) in patients (pts) with relapsed/refractory (R/R) B-cell non-Hodgkin’s lymphoma (B-NHL). 7520
Polivy Polatuzumab vedotin (Pola) + rituximab (R) + lenalidomide (Len) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Primary analysis of a phase 1b/2 trial. 7512
Venclexta/
Venclyxto
Measurable residual disease response in acute myeloid leukemia treated with venetoclax and azacitidine. 7018
Breast cancer
Giredestrant acelERA Breast Cancer (BC): Phase II study evaluating efficacy and safety of giredestrant (GDC-9545) versus physician’s choice of endocrine monotherapy in patients (pts) with oestrogen receptor-positive, HER2-negative (ER+/HER2-) locally advanced or metastatic breast cancer (LA/mBC). TPS1100
Giredestrant persevERA Breast Cancer (BC): Phase III study evaluating the efficacy and safety of giredestrant (GDC-9545) + palbociclib versus letrozole + palbociclib in patients (pts) with oestrogen-receptor-positive, HER2-negative locally advanced or metastatic BC (ER+/HER2– LA/mBC). TPS1103
Giredestrant Safety and activity of single-agent giredestrant (GDC-9545) from a phase Ia/b study in patients (pts) with oestrogen receptor-positive (ER+), HER2-negative locally advanced/metastatic breast cancer (LA/mBC). 1017
Giredestrant Evaluation of pharmacodynamic (PD) and biologic activity in a preoperative window-of-opportunity (WOO) study of giredestrant (GDC-9545) in postmenopausal patients (pts) with oestrogen receptor-positive, HER2-negative (ER+/HER2–) operable breast cancer (BC). 577
Kadcyla Safety of trastuzumab emtansine (T-DM1) in patients (pts) with HER2-positive locally advanced or metastatic breast cancer (mBC): Final results from KAMILLA Cohorts 1 (global) and 2 (Asia). 1039
Phesgo Potential non-drug cost differences associated with the use of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) in the treatment of HER2-positive early breast cancer patients in Western Europe and the United States. 544
Tecentriq The tumour microenvironment (TME) and atezolizumab + nab-paclitaxel (A+nP) activity in metastatic triple-negative breast cancer (mTNBC): IMpassion130. 1006
Colon cancer
Tecentriq Phase Ib/II open-label, randomised evaluation of atezolizumab (atezo) + Imprime PGG (Imprime) + bevacizumab (bev) vs regorafenib (rego) in MORPHEUS: Microsatellite-stable (MSS) metastatic colorectal cancer (mCRC). 3559
Liver cancer
Tecentriq IMbrave150: Exploratory analysis to examine the association between treatment response and overall survival (OS) in patients (pts) with unresectable hepatocellular carcinoma (HCC) treated with atezolizumab (atezo) + bevacizumab (bev) versus sorafenib (sor).

 
4071
Tecentriq IMbrave150: Exploratory efficacy and safety results of hepatocellular carcinoma (HCC) patients (pts) with main trunk and/or contralateral portal vein invasion (Vp4) treated with atezolizumab (atezo) + bevacizumab (bev) versus sorafenib (sor) in a global Ph III study. 4073
Personalised healthcare and health equity
  Association of electronic-health record (EHR)-derived race with BRCA testing in patients (pts) with breast cancer (BC) with similar genetic ancestry (GA) in a clinicogenomic database (CGDB). 6524
  Racial, ethnic, and socioeconomic disparities in treatment outcomes in patients (pts) with diffuse large B-cell lymphoma (DLBCL): A U.S. real-world study using a de-identified electronic health record (EHR)-derived database.

 
e18514
Tumour agnostic
Alecensa Alpha-T: An innovative decentralised (home-based) phase 2 trial of alectinib in ALK-positive (ALK+) solid tumours in a histology-agnostic setting. TPS3155
Gavreto Clinical activity and safety of the RET inhibitor pralsetinib in patients with RET fusion-positive solid tumours: Update from the ARROW trial 3079
Rozlytrek,
Alecensa,
Tecentriq,
Ipatasertib,
Kadcyla,
Inavolisib
Tumour-agnostic precision immuno-oncology and somatic targeting rationale for you (TAPISTRY): a novel platform umbrella trial. TPS3154
Rozlytrek,
Inavolisib,
Ipatasertib,
Tecentriq,
Kadcyla,
Perjeta,
Herceptin
A study evaluating targeted therapies in participants who have advanced solid tumours with genomic alterations or protein expression patterns predictive of response (MyTACTIC). TPS1588


      Blueprint Medicines and Roche are co-developing Gavreto (pralsetinib) globally, excluding Greater China.* Blueprint Medicines and Genentech, a wholly-owned member of the Roche Group, are commercialising Gavreto in the US and Roche has exclusive commercialisation rights for Gavreto outside of the US, excluding Greater China.*

Greater China encompasses Mainland China, Hong Kong, Macau and Taiwan. CStone Pharmaceuticals retains all rights to the development and commercialisation of Gavreto in Greater China under its existing collaboration with Blueprint Medicines.

All trademarks used or mentioned in this release are protected by law. Blueprint Medicines, Gavreto and associated logos are trademarks of Blueprint Medicines Corporation.

About Roche in Oncology
Roche has been working to transform cancer care for more than 50 years, bringing the first specifically designed anti-cancer chemotherapy drug, fluorouracil, to patients in 1962. Roche’s commitment to developing innovative medicines and diagnostics for cancers remains steadfast. The Roche Group’s portfolio of innovative cancer medicines includes: Alecensa®(alectinib); Avastin®(bevacizumab); Cotellic®(cobimetinib); Erivedge®(vismodegib); Gavreto®(pralsetinib); Gazyva®/Gazyvaro®(obinutuzumab); Herceptin®(trastuzumab); Kadcyla®(trastuzumab emtansine); MabThera®/Rituxan®(rituximab); Perjeta®(pertuzumab); Polivy®(polatuzumab vedotin); Tarceva®(erlotinib); Rozlytrek®(entrectinib); Tecentriq®(atezolizumab); Venclexta®/Venclyxto®(venetoclax) in collaboration with AbbVie; Xeloda®(capecitabine); Zelboraf®(vemurafenib). Furthermore, the Roche Group has a robust investigational oncology pipeline focusing on new therapeutic targets and novel combination strategies. For more information on Roche’s approach to cancer, visit www.roche.com.

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 under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

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.

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 twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals 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.

Roche Group Media Relations
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