Genentech 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 personalized healthcare exploring tumor agnostic treatments that demonstrate the impact of coupling biomarker testing with targeted therapies to develop individualized treatment plans
• New data, and drug combination strategies for the treatment of lymphoma from the largest hematology portfolio in industry

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- 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 20 cancer types will be presented at the 2021 ASCO Annual Meeting, which will be held June 4-8, 2021. A total of 132 abstracts that include a Genentech 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., 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 resected 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^TM (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 personalized cancer care for more patients

Genentech will present several studies that take tumor-agnostic approaches to clinical development, and in breast cancer, that may benefit people with rare and common tumors alike. These studies bring together next-generation sequencing, targeted therapies and patient-centric clinical trial design that show how personalized 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 decentralized 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 estrogen 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 program. Glofitamab and mosunetuzumab are both T-cell engaging CD20xCD3 bispecific antibodies that are being studied as single agents or in combination with other Genentech 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 Genentech 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, Genentech’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 tumor-specific therapies and therapy combinations based on the specific characteristics of each person’s disease.

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

Overview of key presentations featuring Genentech medicines

About Gavreto

Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations, regardless of the tissue of origin. Preclinical data have shown that Gavreto inhibits primary RET fusions and mutations that cause cancer in subsets of patients, as well as secondary RET mutations predicted to drive resistance to treatment. Blueprint Medicines and Genentech are co-developing Gavreto for the treatment of patients with various types of RET-altered cancers.

Gavreto™ U.S. Indications

Gavreto™ is a prescription medicine used to treat certain cancers caused by abnormal rearranged during transfection (RET) gene in:

• adults with non-small cell lung cancer (NSCLC) that has spread
• adults and children 12 years of age and older with advanced medullary thyroid cancer (MTC) or MTC that has spread who require a medicine by mouth or injection (systemic therapy)
• adults and children 12 years of age and older with advanced thyroid cancer or thyroid cancer that has spread who require a medicine by mouth or injection (systemic therapy) and who have received radioactive iodine and it did not work or is no longer working

A patient’s healthcare provider will perform a test to make sure that Gavreto is right for them.

Gavreto was approved based on the percentage of patients whose tumor size shrank or disappeared after treatment and how long that response lasted. There are ongoing studies to confirm the benefit of Gavreto.

Important Safety Information

Gavreto may cause serious side effects, including

Lung Problems: Gavreto may cause severe or life-threatening inflammation of the lungs during treatment, that can lead to death. Patients should tell their healthcare provider right away if they have any new or worsening symptoms, including shortness of breath, cough, or fever.

High blood pressure (hypertension): High blood pressure is common with Gavreto and may sometimes be severe. Patients should check their blood pressure regularly during treatment with Gavreto. Patients should tell their healthcare provider if they have increased blood pressure readings or get any symptoms of high blood pressure, including confusion, dizziness, headaches, chest pain or shortness of breath.

Liver problems: Liver problems (increased liver function blood test results) can happen during treatment with Gavreto and may sometimes be serious. A healthcare provider will do blood tests before and during treatment with Gavreto to check patients for liver problems. Patients should tell their healthcare provider right away if they get any signs or symptoms of liver problem during treatment, including yellowing of their skin or the white part of their eyes (jaundice), loss of appetite, nausea or vomiting, dark “tea-colored” urine, pain on the upper right side of their stomach area, sleepiness, bleeding or bruising.

Bleeding problems: Gavreto can cause bleeding which can be serious and cause death. Patients should tell their healthcare provider if they have any signs or symptoms of bleeding during treatment, including vomiting blood or if their vomit looks like coffee-grounds, unusual vaginal bleeding, nose bleeds that happen often, pink or brown urine, drowsiness or difficulty being awakened, red or black (looks like tar) stools, confusion, coughing up blood or blood clots, headache, unusual bleeding or bruising of their skin, change in speech, or menstrual bleeding that is heavier than normal.

Tumor lysis syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. TLS can cause patients to have kidney failure and the need for dialysis treatment, an abnormal heartbeat, and may sometimes lead to hospitalization. A healthcare provider may do blood tests to check patients for TLS. Patients should stay well hydrated during treatment with Gavreto. Patients should call their healthcare provider or get emergency medical help right away if they develop any of these symptoms during treatment with Gavreto: nausea, shortness of breath, vomiting, muscle cramps, weakness, seizures or swelling.

Risk of wound healing problems: Wounds may not heal properly during treatment with Gavreto. Patients should tell their healthcare provider if they plan to have any surgery before or during treatment with Gavreto. Patients should not take Gavreto for at least 5 days before surgery. A healthcare provider should tell patients when they may start taking Gavreto again after surgery.

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

• have lung or breathing problems other than lung cancer
• have high blood pressure
• have bleeding problems
• plan to have surgery
• are pregnant or plan to become pregnant. Gavreto can harm an unborn baby.

Females who are able to become pregnant:

• A healthcare provider will do a pregnancy test before patients start Gavreto.
• Should use an effective form of non-hormonal birth control (contraception) during treatment with Gavreto and for 2 weeks after the final dose of Gavreto.
• Birth control methods that contain hormones (such as birth control pills, injections or transdermal system patches) may not work as well during treatment with Gavreto.
• Patients should talk to their healthcare provider about birth control methods that may be right for them during this time.
• Patients should tell their healthcare provider right away if they become pregnant or think they might be pregnant during treatment with Gavreto.

Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 1 week after their final dose of Gavreto.

• are breastfeeding or plan to breastfeed. It is not known if Gavreto passes into breast milk. Patients should not breastfeed during treatment and for 1 week after their last dose of Gavreto.

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Gavreto may affect the way other medicines work, and other medicines may affect how Gavreto works.

The most common side effects of Gavreto include: constipation, decreased levels of phosphate in the blood, high blood pressure, decreased levels of calcium in the blood, tiredness, decreased levels of body salt (sodium) in the blood, muscle and joint pain, diarrhea, abnormal liver function blood tests, and decreased white blood cell, red blood cell, and platelet counts.

Gavreto may affect fertility in males and females, which may affect a patient’s ability to have children. Patients should talk to their healthcare provider if this is a concern for them.

These are not all of the possible side effects of Gavreto. Patients should call their doctor for medical advice about side effects. Patients are encouraged to report side effects to the FDA. Visit FDA MedWatch or call 1-800-FDA-1088.

Please see the full Prescribing Information and Patient Information for Gavreto.

Blueprint Medicines, Gavreto, YourBlueprint and associated logos are trademarks of Blueprint Medicines Corporation.

About Polivy™ (polatuzumab vedotin-piiq)

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B-cells, an immune cell impacted in some types of non-Hodgkin’s lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to CD79b and destroys these B-cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Roche using Seattle Genetics ADC technology and is currently being investigated for the treatment of several types of NHL.

Polivy U.S. Indication

Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat diffuse large B-cell lymphoma in adults who have progressed after at least two prior therapies.

The accelerated approval of Polivy is based on a type of response rate. There are ongoing studies to confirm the clinical benefit of Polivy.

Important Safety Information

Possible serious side effects

Everyone reacts differently to Polivy therapy, so it’s important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. A patient’s doctor may stop or adjust a patient’s treatment if any serious side effects occur. Patients must contact their healthcare team if there are any signs of these side effects.

• Nerve problems in arms and legs: This may happen as early as after the first dose and may worsen with every dose. If a patient already has nerve pain, Polivy may make it worse. The patient’s doctor will monitor for signs and symptoms, such as changes in sense of touch, numbness or tingling in hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to walking patterns
• Infusion-related reactions: A patient may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of the infusion
• Infections: Patients should contact their healthcare team, if they experience a fever of 100.4°F or higher, chills, cough, or pain during urination. Also, a patient’s doctor may give medication before giving Polivy, which may prevent some infections, and monitor blood counts throughout treatment with Polivy. Treatment with POLIVY can cause severe low blood cell counts
• Rare and serious brain infections: A patient’s doctor will monitor the patient closely for signs and symptoms of these types of infections. Patients should contact their doctor if they experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
• Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
• Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of the skin or the white part of the eyes. Patients may be at higher risk if they already have liver problems or are taking other medication

Side effects seen most often

The most common side effects during treatment were

• Low blood cell counts (platelets, red blood cells, white blood cells)
• Nerve problems in arms and legs
• Tiredness or lack of energy
• Diarrhea
• Nausea
• Fever
• Decreased appetite
• Infections

Polivy may not be for everyone. A patient should talk to their doctor if they are

• Pregnant or may be pregnant: Data have shown that Polivy may harm an unborn baby
• Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for at least 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for at least 5 months after their last Polivy treatment
• Breastfeeding: Women should not breastfeed while taking Polivy and for at least 2 months after the last dose

These may not be all the side effects. Patients should talk to their healthcare provider for more information about the benefits and risks of Polivy treatment.

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.Polivy.com for the full Prescribing Information for additional Important Safety Information.

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 lung cancer called non-small cell lung cancer (NSCLC).

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

• Their cancer has spread or grown, and
• Their cancer tests positive for “high PD-L1”, and
• Their tumor does not have an abnormal “EGFR” or “ALK” gene.

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

• Their cancer has spread or grown and
• Is a type of lung cancer called “non-squamous NSCLC”, and
• Their tumor does not have an abnormal “EGFR” or “ALK” gene.

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

• Their cancer has spread or grown, and
• Is a type of lung cancer called “non-squamous NSCLC”, and
• Their tumor does not have an abnormal “EGFR” or “ALK” gene.

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

• Their cancer has spread or grown, and
• They have tried chemotherapy that contains platinum, and it did not work or is no longer working.
• If a patient’s tumor has an abnormal “EGFR” or “ALK” gene, they 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 in patients with TNBC when their breast cancer:

• Has spread or cannot be removed by surgery. And
• Their 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 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 liver cancer called hepatocellular carcinoma (HCC). Tecentriq may be used with the medicine bevacizumab in patients with HCC if:

• Their cancer has spread or cannot be removed by surgery, and
• They have not received other medicines by mouth or injection through their vein (IV) to treat their cancer.

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 develop any new or worse signs of symptoms, including:

Lung problems

• Cough
• Shortness of breath
• Chest pain

Intestinal problems

• Diarrhea (loose stools) or more bowel movements than usual
• Stools that are black, tarry, sticky, or have blood or mucus
• Severe stomach area (abdomen) pain or tenderness

Liver problems

• Yellowing of the skin or the whites of the eyes
• Severe nausea or vomiting
• Pain on the right side of the stomach area (abdomen)
• Dark urine (tea-colored)
• Bleeding or bruising more easily than normal and feeling less hungry than usual

Hormone gland problems

• Headaches that will not go away or unusual headaches
• Eye sensitivity to light
• Eye problems
• Rapid heartbeat
• Increased sweating
• Extreme tiredness
• Weight gain or weight loss
• Changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
• Feeling more hungry or thirsty than usual
• Urinating more often than usual
• Hair loss
• Feeling cold
• Constipation
• The voice gets deeper
• Dizziness or fainting

Kidney problems

• Decrease in the amount of urine
• Blood in the urine
• Swelling of ankles
• Loss of appetite

Skin problems

• Rash
• Itching
• Skin blistering or peeling
• Painful sores or ulcers in mouth or nose, throat, or genital area
• Fever or flu-like symptoms
• Swollen lymph nodes

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:

• Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
• Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• Persistent or severe muscle pain or weakness, muscle cramps
• Low red blood cells, bruising

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

• Chills or shaking
• Itching or rash
• Flushing
• Shortness of breath or wheezing
• Dizziness
• Feeling like passing out
• Fever
• Back or neck pain

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 also need to 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 received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• Have received radiation treatment to their chest area
• Have a condition that affects the nervous system (such as myasthenia gravis or Guillain-Barre syndrome
• 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:
  • Should have a healthcare provider do a pregnancy test before they start treatment with Tecentriq.
  • 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 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 TNBC with paclitaxel protein-bound include:

• Decrease in hemoglobin (anemia)
• Decreased white blood cells
• Hair loss
• Tingling or numbness in hands and feet
• Feeling tired
• Nausea
• Diarrhea
• Constipation
• Cough
• Headache
• Vomiting
• Decreased appetite

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

• High blood pressure
• Feeling tired or weak
• Too much protein in the urine

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 about the benefits and 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 and Medication Guide for additional Important Safety Information.

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 commercializing Gavreto in the US and Roche has exclusive commercialization 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 commercialization 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 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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