Genentech to Present New Data on Personalized Medicines and Cancer Immunotherapies at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting

South San Francisco, CA   May 10, 2017  Genentech Press Release

• 20 Genentech medicines are included in more than 190 abstracts during ASCO 2017
• New pivotal results for Perjeta® (pertuzumab) and Alecensa® (alectinib) demonstrating improvement over standards of care
• Early results from Genentech’s broad cancer development program preview next generation of cancer immunotherapy, including Genentech’s first T-cell bispecific antibody

SOUTH SAN FRANCISCO, CA — 2017-05-10 00:00:00

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new data on 20 approved and investigational medicines will be presented during the American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6, in Chicago. More than 190 abstracts have been accepted, including two “late breakers” and 24 oral presentations.

“We are making significant advances with personalized medicines and cancer immunotherapies,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “With continued research and collaborations, we are striving to develop medicines and combinations, incorporate sophisticated diagnostics and integrate big data in our effort to get closer to the goal of curing cancer.”

Key highlights from the Genentech oncology portfolio include new results from the APHINITY study in early breast cancer and ALEX study in lung cancer. Both of these studies will be highlighted as part of ASCO’s official press program on Monday, June 5. APHINITY is a randomized Phase III study, investigating Perjeta plus Herceptin^® (trastuzumab) and chemotherapy as an adjuvant (after surgery) treatment for people with HER2-positive early breast cancer. The APHINITY study was conducted in collaboration with the Breast International Group (BIG), Breast European Adjuvant Study Team (BrEAST) and Frontier Science Foundation (FS). ALEX is a randomized, multicenter, open-label Phase III study that compared Alecensa and crizotinib in people with previously untreated ALK-positive non-small cell lung cancer (NSCLC).

There has been great progress in the area of cancer immunotherapy in recent years, and Genentech continues to investigate novel ways to harness the immune system in the fight against cancer as part of its vision to bring the next generation of cancer immunotherapies to patients. With more than 20 investigational cancer immunotherapies in development and 12 in clinical trials, Genentech will be presenting early results on its first T-cell bispecific antibody (CEA-CD3 TCB: RG7802; RO6958688) for the treatment of CEA-positive cancers, including metastatic colorectal cancer (mCRC). These data have been generated from two ongoing dose-escalation Phase I studies in which CEA-CD3 TCB is used alone or in combination with Tecentriq^®(atezolizumab).

Visit http://www.gene.com/asco for resources and perspectives from scientists, doctors and others in the cancer community on important topics at ASCO. Follow Genentech on Twitter via @genentech and keep up to date with ASCO 2017 Annual Meeting news and updates by using the hashtag #ASCO17.

Key presentations featuring Genentech medicines at ASCO 2017

About Perjeta

Perjeta is approved for use in combination with Herceptin and docetaxel in people who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.

Perjeta is approved for use prior to surgery in combination with Herceptin and docetaxel chemotherapy in people with HER2-positive, locally advanced, inflammatory, or early stage (tumor is greater than two centimeters in diameter or node-positive) breast cancer. Perjeta should be used as part of a complete treatment regimen for early stage breast cancer. This use of Perjeta is based on an improvement in the percentage of patients whose cancer shrinks or disappears after treatment. Currently, no data have shown whether or not treatment with Perjeta prior to surgery improves survival.

• The safety of Perjeta in combination with doxorubicin-containing regimens has not been established.
• The safety of Perjeta administered for greater than six cycles for early stage breast cancer has not been established.

Important Safety Information

Side effects with Perjeta

• Not all people have serious side effects; however, side effects with Perjeta therapy are common. It is important for a patient to know what side effects may happen and what symptoms a patient should watch for.
• A patient’s doctor may stop treatment if serious side effects happen. A patient should be sure to contact their healthcare team right away if they have questions or are worried about any side effects.

Most serious side effects

Perjeta may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure).

• A patient’s doctor may run tests to monitor the patient’s heart function before and during treatment with Perjeta.
• Based on test results, a patient’s doctor may hold or discontinue treatment with Perjeta.

Receiving Perjeta during pregnancy can result in the death of an unborn baby and birth defects.

• Birth control should be used while receiving Perjeta and for seven months after a patient’s last dose of Perjeta. If a patient is a mother who is breastfeeding, the patient should talk with her doctor about either stopping breastfeeding or stopping Perjeta.
• If a patient thinks she may be pregnant, the patient should contact her healthcare provider immediately.
• If a patient is exposed to Perjeta during pregnancy, or becomes pregnant while receiving Perjeta or within seven months following the last dose of Perjeta in combination with Herceptin, the patient is encouraged to enroll in the MotHER Pregnancy Registry by contacting (800) 690-6720 or visiting http://www.motherpregnancyregistry.com, and to report Perjeta exposure to Genentech at (888) 835-2555.

Other possible serious side effects

• Perjeta should not be used in patients who are allergic to pertuzumab or to any of the ingredients in Perjeta.
• Infusion-related reactions: Perjeta is a medicine that is delivered into a vein through a needle. This process can cause reactions known as infusion-related reactions. The most common infusion-related reactions when receiving Perjeta, Herceptin and docetaxel were feeling tired, abnormal or altered taste, allergic reactions, muscle pain and vomiting. The most common infusion-related reactions when receiving Perjeta alone were fever, chills, feeling tired, headache, weakness, allergic reactions and vomiting.
• Severe allergic reactions: Some people receiving Perjeta may have severe allergic reactions, called hypersensitivity reactions or anaphylaxis. This reaction may be severe, may happen quickly and may affect many areas of the body.

Knowing if Perjeta is right for the patient

Perjeta has only been shown to work in people with HER2-positive breast cancer. A patient must have a HER2 test to know if their breast cancer is HER2-positive before receiving an anti-HER2 treatment, such as Perjeta.

Most common side effects

The most common side effects of Perjeta when given with Herceptin and docetaxel for treatment of breast cancer that has spread to other parts of the body (metastatic) are:

• Diarrhea
• Hair loss
• Low levels of white blood cells with or without a fever
• Nausea
• Feeling tired
• Rash
• Damage to the nerves (numbness, tingling, pain in hands/feet)

The most common side effects of Perjeta when given with Herceptin and docetaxel as part of an early breast cancer regimen before surgery are:

• Hair loss
• Diarrhea
• Nausea
• Low levels of white blood cells with or without a fever

The most common side effects of Perjeta when given with Herceptin and docetaxel following three cycles of epirubicin, cyclophosphamide and fluorouracil as part of an early breast cancer regimen before surgery are:

• Feeling tired
• Hair loss
• Diarrhea
• Nausea
• Vomiting
• Low levels of white blood cells with or without a fever

The most common side effects of Perjeta when given with Herceptin, docetaxel and carboplatin as part of an early breast cancer regimen before surgery are:

• Feeling tired
• Hair loss
• Diarrhea
• Nausea
• Vomiting
• Low levels of white blood cells with or without a fever
• Low platelet count
• Low levels of red blood cells

Patients are encouraged to report side effects to Genentech and the FDA. 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 see the full Prescribing Information for additional Important Safety Information, including most serious side effects, at http://www.perjeta.com.

About Herceptin

Adjuvant Breast Cancer

Herceptin is approved for the treatment of early stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2-positive) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* Herceptin can be used in several different ways:

• As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as “AC→TH.”
• With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as “TCH.”
• Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy).

Patients are selected for therapy based on an FDA-approved test for Herceptin.

*High risk is defined as ER/PR-positive with one of the following features: tumor size greater than 2 cm, age less than 35 years, or tumor grade 2 or 3.

Metastatic Breast Cancer

Herceptin has two approved uses in metastatic breast cancer:

• Herceptin in combination with the chemotherapy drug paclitaxel is approved for the first-line treatment of HumanEpidermal growth factor Receptor 2-positive (HER2-positive) metastatic breast cancer.
• Herceptin alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease.

Patients are selected for therapy based on an FDA-approved test for Herceptin.

Gastric Cancer

Herceptin is approved, in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil), for the treatment of HER2-positive metastatic cancer of the stomach or gastroesophageal junction (where the esophagus meets the stomach) in patients who have not received prior treatment for their metastatic disease.

Patients are selected for therapy based on an FDA-approved test for Herceptin.

Important Safety Information

Possible serious side effects with Herceptin

Not all people have serious side effects, but side effects with Herceptin therapy are common.

Although some people may have a life-threatening side effect, most do not.

A patient’s doctor will stop treatment if any serious side effects occur.

Herceptin is not for everyone. A patient should be sure to contact their doctor if they are experiencing any of the following:

HEART PROBLEMS

These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both Herceptin and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. A patient’s doctor will check for signs of heart problems before, during, and after treatment with Herceptin.

INFUSION REACTIONS, including:

• Fever and chills
• Feeling sick to your stomach (nausea)
• Throwing up (vomiting)
• Pain (in some cases at tumor sites)
• Headache
• Dizziness
• Shortness of breath

These signs usually happen within 24 hours after receiving Herceptin.

A patient should be sure to contact their doctor if they:

Are a woman who could become pregnant, or may be pregnant

Herceptin may result in the death of an unborn baby or birth defects. Contraception should be used while receiving Herceptin and after a patient’s last dose of Herceptin. If a patient is exposed to Herceptin during pregnancy or within seven months of becoming pregnant, the patient is encouraged to enroll in the MotHER Pregnancy Registry by contacting (800) 690-6720 or visiting http://www.motherpregnancyregistry.com and to report Herceptin exposure to Genentech at (888) 835-2555.

Have any signs of SEVERE LUNG PROBLEMS, including:

• Severe shortness of breath
• Fluid in or around the lungs
• Weakening of the valve between the heart and the lungs
• Not enough oxygen in the body
• Swelling of the lungs
• Scarring of the lungs

A patient’s doctor may check for signs of severe lung problems when he or she examines the patient.

Have LOW WHITE BLOOD CELL COUNTS

Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving Herceptin plus chemotherapy than in patients receiving chemotherapy alone.

A patient’s doctor may check for signs of low white blood cell counts when he or she examines the patient.

Side effects seen most often with Herceptin

Some patients receiving Herceptin for breast cancer had the following side effects:

• Fever
• Feeling sick to your stomach (nausea)
• Throwing up (vomiting)
• Infusion reactions
• Diarrhea
• Infections
• Increased cough
• Headache
• Feeling tired
• Shortness of breath
• Rash
• Low white and red blood cell counts
• Muscle pain

Some patients receiving Herceptin for metastatic stomach cancer had the following side effects:

Low white blood cell counts

• Diarrhea
• Feeling tired
• Low red blood cell counts
• Swelling of the mouth lining
• Weight loss
• Upper respiratory tract infections
• Fever
• Low platelet counts
• Swelling of the mucous membranes
• Swelling of the nose and throat
• Change in taste

A patient should contact their doctor immediately if they have any of the side effects listed above.

Patients are encouraged to report side effects to Genentech and the FDA. 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 see the full Prescribing Information, including Boxed WARNINGS and additional Important Safety Information, at http://www.herceptin.com.

About Alecensa

Alecensa is a kinase inhibitor approved for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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

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

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 orhttp://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 Tecentriq

Tecentriq is a prescription medicine used to treat:

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 (advanced urothelial carcinoma), and
  • you are not able to take chemotherapy that contains a medicine called cisplatin, 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. There is an ongoing study to confirm clinical benefit.

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

• Tecentriq may be used 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.

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

Important Safety Information

Important Information About Tecentriq

Tecentriq can cause the immune system to attack normal organs and tissues in many areas of the body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.

Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat a patient with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with Tecentriq if a patient has severe side effects.

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, or 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, 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 in the stools or dark, tarry, sticky stools, severe stomach area (abdomen) pain or tenderness
• Hormone Gland Problems (especially the pituitary, thyroid, adrenal glands and pancreas) – 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, voice gets deeper, urinating more often than usual, nausea or vomiting, stomach area (abdomen) pain
• Nervous System Problems (neuropathy, meningitis, encephalitis) – Signs and symptoms of nervous system problems may include: severe muscle weakness, numbness or tingling in hands and feet, fever, confusion, changes in mood or behavior, extreme sensitivity to light, neck stiffness
• Inflammation of the Eyes – Signs and symptoms may include: blurry vision, double vision, other vision problems, eye pain or redness
• Severe Infections – Signs and symptoms of infection may include: fever, cough, frequent urination, flu-like symptoms, pain when urinating
• Severe Infusion Reactions – Signs and symptoms of infusion reactions may include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling like passing out, back or neck pain, and swelling of the face or lips

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 their 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
  • If patients are able to become pregnant, they should use an effective method of birth control during 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
  • Do 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 in people with urothelial carcinoma include:

• feeling tired
• decreased appetite
• nausea
• constipation
• urinary tract infection
• diarrhea
• fever

The most common side effects of Tecentriq in people with non-small cell lung cancer include:

• feeling tired
• decreased appetite
• shortness of breath
• cough
• nausea
• muscle or bone pain
• constipation

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.

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 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 or 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.