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Wednesday, May 6, 2020

New Data at the ASCO20 Virtual Scientific Program Reflects Genentech’s Commitment to Accelerating Progress in Cancer Care

First clinical data from tiragolumab, Genentech’s novel anti-TIGIT cancer immunotherapy, in combination with Tecentriq in people with PD-L1-positive metastatic non-small cell lung cancer (NSCLC)

Updated overall survival data for Alecensa in people living with anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC

South San Francisco, CA -- May 6, 2020 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new data from clinical trials of 19 approved and investigational medicines across 21 cancer types will be presented at the ASCO20 Virtual Scientific Program organized by the American Society of Clinical Oncology (ASCO), which will be held May 29-31, 2020. A total of 120 abstracts that include a Roche medicine will be presented at this year's meeting.

"At ASCO, we will present new data from many investigational and approved medicines across our broad oncology portfolio," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “These efforts exemplify our long-standing commitment to improving outcomes for people with cancer, even during these unprecedented times. By integrating our medicines and diagnostics together with advanced insights and novel platforms, Genentech is uniquely positioned to deliver the healthcare solutions of the future."

Together with its partners, Genentech is pioneering a comprehensive approach to cancer care, combining new diagnostics and treatments with innovative, integrated data and access solutions for approved medicines that will both personalize and transform the outcomes of people affected by this deadly disease.

Key presentations

First results of tiragolumab, Genentech’s novel cancer immunotherapy designed to bind to TIGIT, will be shared. These results, from the Phase II CITYSCAPE study, examine tiragolumab in combination with Tecentriq ® (atezolizumab) compared with Tecentriq alone as an initial treatment for people with PD-L1-positive, locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC). In addition, updated five-year overall survival rates with Alecensa® (alectinib) in people living with treatment-naive anaplastic lymphoma kinase (ALK)-positive metastatic/advanced NSCLC will be presented. With five approved lung cancer medicines and an extensive pipeline across multiple subtypes, Genentech's ultimate aim is to provide an effective treatment option for each person diagnosed with the disease, tailored to the unique characteristics of their tumors.

Studies featured from partnerships with Flatiron Health and Foundation Medicine demonstrate how the use of next-generation sequencing (NGS) may help inform treatment decisions, optimize testing and enable personalized therapy, including an ongoing additional study designed to prospectively link longitudinal, real-world clinical data with genomic, imaging and outcomes data for people with advanced lung cancers. The study is monitoring circulating tumor DNA (ctDNA) using FoundationOne® Liquid, and tumor tissue samples will be genomically profiled using FoundationOne ® CDx.

Follow Genentech on Twitter via @Genentech and keep up to date with ASCO news and updates by using the hashtag #ASCO20.

Overview of key presentations featuring Genentech medicines at ASCO 2020

Medicine

Abstract title

Abstract number

Lung cancer

Tiragolumab

Primary analysis of a randomized, double-blind, phase II study of the anti-TIGIT antibody tiragolumab (tira) plus atezolizumab (atezo) versus placebo plus atezo as first-line (1L) treatment in patients with PD-L1-selected NSCLC (CITYSCAPE)

Abstract 9503 (oral)

Alecensa

Updated overall survival (OS) and safety data from the randomized, phase III ALEX study of alectinib (ALC) versus crizotinib (CRZ) in untreated advanced ALK+ NSCLC

Abstract 9518

(poster discussion 284)

Tecentriq

Patient-reported outcomes (PROs) in the randomized, phase III IMpower110 study of atezolizumab (atezo) vs chemotherapy in 1L metastatic NSCLC

Abstract 9594

(poster 360)

Tecentriq

IMpower150: exploratory analysis of brain metastases development

Abstract 9587

(poster 353)

Tecentriq

IMpower150: exploratory efficacy analysis in patients (pts) with bulky disease

N/A

e-publication

Flatiron Health data in lung cancer

Real World Data

A multi-stakeholder platform to prospectively link longitudinal real-world clinico-genomic, imaging, and outcomes data for patients with metastatic lung cancer

Abstract TPS2087

(poster 79)

Real World Data

Genomic testing among patients (pts) with newly diagnosed advanced non-small cell lung cancer (aNSCLC) in the United States: a contemporary clinical practice patterns study

Abstract 9592

(poster 358)

Solid tumors

Rozlytrek

Updated entrectinib data in children and adolescents with recurrent or refractory solid tumors, including primary CNS tumors

Abstract 107

(clinical science symposium)

Rozlytrek

Efficacy and safety of entrectinib in patients (pts) with NTRK-Fusion-Positive (NTRK-fp) solid tumors: an updated integrated analysis

Abstract 3605

(poster 335)

Genitourinary and gastrointestinal cancers

Tecentriq

IMvigor010: primary analysis from a phase III randomized study of adjuvant atezolizumab (atezo) versus observation (obs) in high-risk muscle-invasive urothelial carcinoma (MIUC)

Abstract 5000

(oral)

Tecentriq

Tumor, immune, and stromal characteristics associated with clinical outcomes with atezolizumab (atezo) + platinum-based chemotherapy (PBC) or atezo monotherapy (mono) versus PBC in metastatic urothelial cancer (mUC) from the phase III IMvigor130 study

Abstract 5011

(clinical science symposium)

Tecentriq

Phase Ib/II open-label, randomized evaluation of 2L atezolizumab (atezo) + PEGPH20 versus control in MORPHEUS-pancreatic ductal adenocarcinoma (M-PDAC) and MORPHEUS-gastric cancer (M-GC)

Abstract 4540

(poster 148)

Tecentriq, Avastin

Complete responses (CR) in patients receiving atezolizumab (atezo) + bevacizumab (bev) vs sorafenib (sor) in IMbrave150: a phase III clinical trial for unresectable hepatocellular carcinoma (HCC)

Abstract 4596

(poster 204)

Ipatasertib

Circulating tumor DNA (ctDNA) dynamics associate with treatment response and radiological progression-free survival (rPFS): analyses from a randomized phase II trial in metastatic castration-resistant prostate cancer (mCRPC)

Abstract 5508

(oral)

Blood cancer

Venclexta

Impact of premature venetoclax (Ven) discontinuation/interruption on outcomes in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL): Phase III MURANO study results

Abstract 8028

(poster 361)

Venclexta, Gazyva

Fixed-duration venetoclax-obinutuzumab for previously untreated patients with chronic lymphocytic leukemia: follow-up of efficacy and safety results from the multicenter, open-label, randomized, phase III CLL14 trial

Abstract 8027

(poster 360)

Gazyva

Comparison of efficacy and safety with obinutuzumab plus chemotherapy versus rituximab plus chemotherapy in patients with previously untreated follicular lymphoma: Updated results from the phase III Gallium Study

Abstract 8023

(poster 356)

Breast cancer

Kadcyla, Perjeta

Primary analysis of KAITLIN: A phase III study of trastuzumab emtansine (T-DM1) + pertuzumab versus trastuzumab + pertuzumab + taxane, after anthracyclines as adjuvant therapy for high-risk HER2-positive early breast cancer (EBC)

Abstract 500

(oral)

Kadcyla

Biomarker data from KATHERINE: A phase III study of adjuvant trastuzumab emtansine (T-DM1) vs trastuzumab (H) in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer

Abstract 502

(oral)

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 when your bladder cancer:

  • has spread or cannot be removed by surgery, and if you have any one of the following conditions:
    • you are not able to take chemotherapy that contains a medicine called cisplatin, and your cancer tests positive for “PD-L1”, or
    • you are not able to take chemotherapy that contains any platinum regardless of “PD-L1” status, or
    • you have tried chemotherapy that contains platinum, and it did not work or is no longer working.

The approval of Tecentriq in these patients is based on a study that measured response rate and duration of response. 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 with chemotherapy and other anti-cancer medicines as your first treatment when your lung cancer:
    • has spread or grown, and
    • is a type called “non-squamous NSCLC”, and
    • your tumor does not have an abnormal “EGFR” or “ALK” gene.
  • Tecentriq may be used alone when your lung cancer:
    • has spread or grown, and
    • you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
    • If your tumor has an abnormal “EGFR” or “ALK” gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.

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

Tecentriq may be used with the medicine paclitaxel protein-bound when your breast cancer:

○ has spread or cannot be removed by surgery, and

○ your cancer tests positive for “PD-L1.”

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 results of an ongoing study to confirm benefit.

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

  • Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment when your lung cancer:
    • is a type called “extensive-stage small cell lung cancer,” which means that it has spread or grown.

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

Important Safety Information
What is the most important information about Tecentriq?
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 should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.

Tecentriq can cause serious side effects, including:

  • Lung problems (pneumonitis)–signs and symptoms of pneumonitis may include new or worsening cough, shortness of breath, and chest pain
  • Liver problems (hepatitis)–signs and symptoms of hepatitis may include yellowing of the skin or the whites of the eyes, severe nausea or vomiting, pain on the right side of the stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual
  • Intestinal problems (colitis)–signs and symptoms of colitis may include diarrhea (loose stools) or more bowel movements than usual, blood or mucus in stools or dark, tarry, sticky stools, and severe stomach area (abdomen) pain or tenderness
  • Hormone gland problems (especially the thyroid, adrenal glands, pancreas, and pituitary) –signs and symptoms that the hormone glands are not working properly may include headaches that will not go away or unusual headaches, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, changes in mood or behavior (such as decreased sex drive, irritability, or forgetfulness), feeling cold, constipation, the voice gets deeper, urinating more often than usual, nausea or vomiting, and stomach area (abdomen) pain
  • Problems in other organs–signs and symptoms may include severe muscle weakness, numbness or tingling in hands or feet, confusion, blurry vision, double vision, or other vision problems, changes in mood or behavior, extreme sensitivity to light, neck stiffness, eye pain or redness, skin blisters or peeling, chest pain, irregular heartbeat, shortness of breath, or swelling of the ankles
  • Severe infections–signs and symptoms of infection may include fever, cough, flu-like symptoms, pain when urinating, and frequent urination or back pain
  • Severe infusion reactions–signs and symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, swelling of your face or lips, dizziness, fever, feeling like passing out, and back or neck pain

Getting medical treatment right away may help keep these problems from becoming more serious. 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:

  • have immune system problems (such as Crohn’s disease, ulcerative colitis, or lupus); have had an organ transplant; have lung or breathing problems; have liver problems; have a condition that affects the nervous system (such as myasthenia gravis or Guillain-Barre syndrome); or are being treated for an infection
  • are pregnant or plan to become pregnant. Tecentriq can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with Tecentriq. Females who are able to become pregnant:
    • a healthcare provider should do a pregnancy test before they start treatment with Tecentriq
    • they should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq
  • are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into the breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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

  • feeling tired or weak
  • nausea
  • cough
  • shortness of breath
  • decreased appetite

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

  • feeling tired or weak
  • nausea
  • hair loss
  • constipation
  • diarrhea
  • decreased appetite

The most common side effects of Tecentriq when used in triple-negative breast cancer with paclitaxel protein-bound include:

  • hair loss
  • tingling or numbness in hands or feet
  • feeling tired
  • nausea
  • diarrhea
  • low red blood cells (anemia)
  • constipation
  • cough
  • headache
  • low white blood cells
  • vomiting
  • decreased appetite

Tecentriq may cause fertility problems in females, which may affect the 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 about the benefits and side effects of Tecentriq.

Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at 1-888-835-2555.

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

About Alecensa (alectinib)
Alecensa is a kinase inhibitor approved for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

Alecensa U.S. Indication
Alecensa is a kinase inhibitor approved for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

Important Safety Information
Everyone reacts differently to treatment with Alecensa. It’s important to know the most serious and most common side effects with Alecensa.

A doctor may lower the dose or stop treatment with Alecensa if any serious side effects occur. Patients taking Alecensa should contact their doctor right away if they have any of the following side effects.

Alecensa may cause serious side effects, including:

Liver problems (hepatotoxicity). Alecensa may cause liver injury. A doctor will do blood tests at least every 2 weeks for the first 3 months and as needed during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they experience any of the following signs and symptoms:

  • Feeling tired
  • Feeling less hungry than usual
  • Yellowing of the skin or whites of the eyes
  • Dark urine
  • Itchy skin
  • Nausea or vomiting
  • Pain on the right side of stomach area
  • Bleeding or bruising more easily than normal

Lung problems. Alecensa may cause severe or life-threatening swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Patients taking Alecensa should tell their doctor right away if they have any new or worsening symptoms, including:

  • Trouble breathing
  • Shortness of breath
  • Fever
  • Cough

Kidney problems. Alecensa may cause severe or life-threatening kidney problems. Tell your healthcare provider right away if you have a change in the amount or color of your urine, or if you get new or worsening swelling in your legs or feet.

Slow heartbeat (bradycardia). Alecensa may cause very slow heartbeats that can be severe. A doctor will check a patient’s heart rate and blood pressure during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they feel dizzy, lightheaded, or faint during treatment with Alecensa. Patients taking Alecensa should tell their doctor if they take any heart or blood pressure medicines.

Muscle pain, tenderness, and weakness (myalgia). Muscle problems are common with Alecensa and can be severe. A doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they have any new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.

Before taking Alecensa, patients should tell their doctor about all medical conditions, including if they:

  • Have liver problems
  • Have lung or breathing problems
  • Have a slow heartbeat
  • Are pregnant or plan to become pregnant. Alecensa can harm an unborn baby. Patients taking Alecensa should tell their doctor right away if they become pregnant during treatment with Alecensa or think they may be pregnant
    • Women who are able to become pregnant should use effective birth control during treatment with Alecensa and for one week after the final dose of Alecensa
    • Men who have female partners that are able to become pregnant should use effective birth control during treatment with Alecensa and for three months after the final dose of Alecensa
    • Are breastfeeding or plan to breastfeed. It is not known if Alecensa passes into breast milk. A patient should not breastfeed during treatment with Alecensa and for one week after the final dose of Alecensa. Patients should talk with their doctor about the best way to feed their baby during this time.

Patients taking Alecensa should tell their doctor about all the medicines they take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

Patients taking Alecensa should avoid spending time in the sunlight during treatment with Alecensa and for seven days after the final dose of Alecensa. Patients taking Alecensa may burn more easily and get severe sunburns. Patients taking Alecensa should use sunscreen and lip balm with a SPF 50 or greater to help protect against sunburn.

The most common side effects of Alecensa include:

  • Tiredness
  • Constipation
  • Swelling in hands, feet, ankles, and eyelids
  • Low red blood cell count

These are not all of the possible side effects of Alecensa. For more information, patients should ask their doctor or pharmacist. Patients should call their doctor for medical advice about side effects.

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

Please see additional Important Safety Information in full Prescribing Information, including Patient Information .

About Genentech in Personalized Healthcare

For more than 20 years, Genentech has helped lay the scientific groundwork for personalized healthcare with treatments that target the underlying biology of cancer and other diseases. Now, with profound changes in data and technology transforming how medicines are discovered, developed and delivered to patients, we are uniquely positioned to extend this approach across all of healthcare. With our ability to integrate research and development, personalized diagnosis, disease monitoring and treatment access, we are advancing personalized healthcare for every aspect of the patient experience.

Our strategy is rooted in groundbreaking science that can accelerate drug discovery and development. We are also leveraging technologies such as real-world datasets, artificial intelligence, genomic profiling and digital health across our therapeutic portfolio, with an initial emphasis on oncology, neurology, ophthalmology and diagnostics. Through collaborations with academic institutions, industry partners, patients, physicians and regulatory agencies, our goal is to dramatically improve the performance of the entire healthcare ecosystem and the lives of every patient.

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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