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Genentech to Present Data From Industry-Leading Portfolio at ESMO 2021 Showing Significant Progress in Early Stage and Uncommon Cancers

— First data to be presented from the Phase II coopERA Breast Cancer study evaluating neoadjuvant giredestrant treatment for estrogen receptor-positive, HER2-negative breast cancer —

— New data from the Phase III IMpower010 study provide further insights into the role of Tecentriq in early-stage non-small cell lung cancer —

— Genomic data from the Phase II CUPISCO study in Cancer of Unknown Primary, an uncommon type of cancer with high unmet need, could support diagnostics and more personalized treatment plans —

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new oncology data will be presented at the European Society for Medical Oncology (ESMO) Congress, which will be held September 16-21, 2021. With one of the broadest oncology pipelines and portfolios in the industry, Genentech presentations include late-breaking abstracts featuring data in early-stage breast cancer and early-stage lung cancer, and a presentation on cancer of unknown primary (CUP), which has been selected for inclusion in the ESMO Press Program.

“Our data at ESMO 2021 show how we continue to pursue potentially transformative advances in breast and lung cancer, particularly in earlier stage settings where the chance for cure is highest,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Furthermore our efforts in personalized healthcare, exemplified by our insights in CUP, will help address the needs of many patients who are diagnosed at a late stage.”

Breast Cancer Highlights

First Phase II data will be presented from an interim analysis of giredestrant, a next-generation oral selective estrogen receptor degrader, in neoadjuvant, estrogen receptor-positive, HER2-negative early breast cancer. Over 70% of breast cancer cases are hormone receptor (HR)-positive, and there is a need for more effective and tolerable treatments, since up to 30% of patients develop resistance to standard-of-care treatments and in the adjuvant setting half of patients stop treatment due to the toll of side effects. Our efforts in this area represent a step towards making the treatment of patients with HR-positive breast cancer more effective and less debilitating in order to reduce the burden of treatment. This study further showcases Genentech’s commitment to identifying meaningful treatment options for patients with breast cancer through a comprehensive development program that includes early and late-stage HR-positive, HER2-positive and triple-negative forms of the disease.

Lung Cancer Highlights

New results from the Phase III IMpower010 study, to be presented during Presidential Symposium Three, highlight patterns of relapse and subsequent therapy following treatment with Tecentriq® (atezolizumab) versus standard of care in early lung cancer, and help to define how Tecentriq fits into the adjuvant treatment pathway. These findings are particularly important as real-world data, which will also be presented at ESMO, will provide detail on the proportion of people with early non-small cell lung cancer (NSCLC) in the United States who do not receive adjuvant treatment despite guidelines recommending that they do so. These real-world data also highlight survival outcomes in this setting and reinforce the need for more effective adjuvant therapy in NSCLC, as half of all people with early-stage lung cancer today still experience disease recurrence following surgery.

The Phase III IMpower010 study showed adjuvant Tecentriq improved disease-free survival in PD-L1-positive early-stage lung cancer, compared with best supportive care a first in cancer immunotherapy. Based on the outcomes from this study, the U.S. Food and Drug Administration recently granted Priority Review under the Real-Time Oncology Review pilot program to Tecentriq as an adjuvant treatment for certain people with early NSCLC, and is expected to make a decision later this year.

Innovation in Personalized Healthcare

Latest results from a preliminary descriptive molecular analysis based on the CUPISCO study, which will be featured in the ESMO Press Program, shed further light on the genomic profiles of patients with poor-prognosis CUP. These results highlight the importance of comprehensive genomic profiling for patients with CUP and identify therapeutically relevant genomic alterations in a significant proportion of patients, which may help to inform a more personalized treatment plan. In CUP, doctors cannot identify the location of the original (primary) tumor and can only find metastases. This causes practical problems since traditional treatment approaches rely on the site of origin being known, and as such, most patients are treated with nonspecific chemotherapy. Unfortunately, prognosis remains poor and the median survival following diagnosis is just six to 12 months, reinforcing the need for improved diagnosis and treatment.

Real-world data from the United States examining the use of Foundation Medicine’s comprehensive genomic testing prior to first-line therapy in patients with metastatic colorectal cancer will also be presented and underpin Genentech’s efforts to drive more widespread and earlier testing for patients with cancer.

Keep up to date with ESMO news and updates by using the hashtag #ESMO21 and follow Genentech on Twitter via @Genentech and on LinkedIn.

Overview of key presentations featuring Genentech medicines

Medicine

Abstract title

Abstract number

Breast cancer

Giredestrant

Neoadjuvant giredestrant (GDC-9545) + palbociclib (palbo) vs anastrozole (A) + palbo in post-menopausal women with oestrogen receptor-positive, HER2-negative, untreated early breast cancer (ER+/HER2– eBC): Interim analysis of the randomised, open-label, phase 2 coopERA BC study

LBA14

 

Kadcyla

Trastuzumab emtansine (T-DM1) in Asian patients with previously treated HER2-positive locally advanced (LA) or metastatic breast cancer (MBC): data from the phase 3 EMILIA study

284P

Kadcyla

Trial in progress – ASTEFANIA: A phase 3 study of trastuzumab emtansine (T-DM1) plus atezolizumab or placebo as adjuvant therapy in patients with residual invasive breast cancer after neoadjuvant HER2-targeted therapy and chemotherapy

202TiP

Kadcyla

Trial in progress – KATE3: A phase 3 study of trastuzumab emtansine (T-DM1) in combination with atezolizumab or placebo in patients with previously treated HER2-positive and PD-L1–positive locally advanced or metastatic breast cancer

329TiP

Real-world data

Real-world Outcomes of Hormone Receptor-Positive (HR+) HER2-Negative (HER2-) metastatic Breast Cancer (mBC) with High Tumor Mutational Burden (hTMB) Treated with Immune Checkpoint Inhibitors (ICI)

237P

Lung cancer

Tecentriq

IMpower010: Patterns of relapse and subsequent therapy from a Phase III study of atezolizumab (atezo) vs best supportive care (BSC) after adjuvant chemotherapy (chemo) in stage IB-IIIA non-small cell lung cancer (NSCLC)

LBA9

Tiragolumab

Trial in progress – SKYSCRAPER-03: Phase III, Open-Label Randomised Study of Atezolizumab + Tiragolumab vs Durvalumab in Patients with Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed After Platinum-based Concurrent Chemoradiation (cCRT)

1190TiP

Tecentriq

Atezolizumab (atezo) vs platinum-based chemo in blood-based tumour mutational burden-positive (bTMB+) patients (pts) with first line (1L) advanced/metastatic (m)NSCLC: results of the Blood First Assay Screening Trial (BFAST) Phase 3 Cohort C

1281O

Real-world data

Real-world Adjuvant Treatment Patterns and Survival Outcomes among early NSCLC US Patients

1158P

Real-world data

Adoption and early clinical outcomes of atezolizumab (atezo) + carboplatin and etoposide (CE) in patients with extensive-stage small cell lung cancer (ES-SCLC) in the real-world (RW) setting

1650P

Bladder cancer

Tecentriq

Cisplatin (cis)-related immunomodulation and efficacy with atezolizumab (atezo) + cis- vs carboplatin (carbo)-based chemotherapy (chemo) in metastatic urothelial cancer (mUC)

658MO

Gastric cancer

Tecentriq

Phase Ib/II open-label, randomised evaluation of second-line atezolizumab (atezo) + linagliptin (lina) vs ramucirumab (ram) + paclitaxel (pac) in MORPHEUS-Gastric Cancer

1382P

Head and neck cancer

Tiragolumab

Trial in progress – SKYSCRAPER-09: A Phase II, Randomised, Double-blinded Study of Atezolizumab (Atezo) + Tiragolumab (Tira) and Atezo + Placebo as First-line (1L) Therapy for Recurrent/Metastatic (R/M) PD-L1+ Squamous Cell Carcinoma of the Head and Neck (SCCHN)

927TiP

Hepatocellular carcinoma

Tecentriq

IMbrave150: exploratory efficacy and safety results in patients with hepatocellular carcinoma without macrovascular invasion (MVI) or extrahepatic spread (EHS) treated with atezolizumab (atezo) + bevacizumab (bev) or sorafenib (sor)

932P

Tumor agnostic treatment and personalized healthcare

Comprehensive genomic profiling

Baseline mutational profiles of patients (pts) with carcinoma-of-unknown-primary-origin (CUP) enrolled onto CUPISCO

1804P

Comprehensive genomic profiling

Fusion and rearrangement (RE) detection using DNA and RNA-based comprehensive genomic profiling (CGP) of sarcomas

1532P

Comprehensive genomic profiling

Circulating tumor DNA (ctDNA) from patients (pts) with advanced colorectal cancer (CRC) is enriched for EGFR extracellular domain (ECD) mutations

457P

Tumor agnostic

Blood tumor mutational burden (bTMB) and efficacy of immune checkpoint inhibitors (ICIs) in advanced solid tumors: SCRUM-Japan MONSTAR-SCREEN

80P

Real-world data

Comprehensive genomic profiling (CGP) and PD-L1 IHC in patients (pts) with advanced non-small cell lung cancer (aNSCLC): Testing and Treatment Patterns in the real-world (RW) setting

1301P

Real-world data

Utilisation and predictors of genomic testing prior to first-line (1L) therapy in patients (pts) with metastatic colorectal cancer (mCRC)

477P

About Tecentriq (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq U.S. Indications

Tecentriq is a prescription medicine used to treat adults with:

A type of bladder and urinary tract cancer called urothelial carcinoma.

Tecentriq may be used in patients with urothelial carcinoma if their bladder cancer has spread or cannot be removed by surgery, and if they have any one of the following conditions:

The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

A type of lung cancer called non-small cell lung cancer (NSCLC).

Tecentriq may be used alone as the first treatment in patients with lung cancer if:

Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as the first treatment in patients with lung cancer if:

Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as the first treatment in patients with lung cancer if:

Tecentriq may be used alone in patients with lung cancer if:

A type of breast cancer called triple-negative breast cancer (TNBC).

Tecentriq may be used with the medicine paclitaxel protein-bound in patients with TNBC when their breast cancer:

The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

Tecentriq is not for use with the medicine paclitaxel (a different medicine than paclitaxel protein-bound) in patients with TNBC when their breast cancer has spread or cannot be removed by surgery.

A type of lung cancer called small cell lung cancer (SCLC).

Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as the first treatment in patients with SCLC when their lung cancer:

A type of liver cancer called hepatocellular carcinoma (HCC).

Tecentriq may be used with the medicine bevacizumab in patients with HCC if:

A type of skin cancer called melanoma.

Tecentriq may be used with the medicines cobimetinib and vemurafenib when in patients with melanoma when their skin cancer:

Healthcare providers will perform a test to make sure this Tecentriq combination is right for the patient.

It is not known if Tecentriq is safe and effective in children.

Important Safety Information

The most important information about Tecentriq is:

Tecentriq can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. Patients can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after treatment has ended.

Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.

Lung problems

Intestinal problems

Liver problems

Hormone gland problems

Kidney problems

Skin problems

Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Patients should call or see their healthcare provider right away for any new or worse signs or symptoms, including:

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic).

These complications can be serious and can lead to death. These complications may happen if a patient underwent transplantation either before or after being treated with Tecentriq. A patient’s healthcare provider will monitor them for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider will check patients for these problems during their treatment with Tecentriq. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with Tecentriq if patients have severe side effects.

Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:

The most common side effects of Tecentriq when used alone include:

The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

The most common side effects of Tecentriq when used in TNBC with paclitaxel protein-bound include:

The most common side effects of Tecentriq when used in hepatocellular carcinoma (HCC) with bevacizumab include:

The most common side effects of Tecentriq when used in melanoma with cobimetinib and vemurafenib include:

Tecentriq may cause fertility problems in females, which may affect their ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.

These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information. Patients should call their doctor for medical advice about side effects of Tecentriq.

Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.

Please visit http://www.Tecentriq.com for the Full Tecentriq Prescribing Information for additional Important Safety Information.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

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011 41 61 687 8503

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