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Wednesday, May 9, 2018

Genentech Provides Update on Phase III Study Of TECENTRIQ (Atezolizumab) and COTELLIC (Cobimetinib) in People With Heavily Pre-Treated Locally Advanced or Metastatic Colorectal Cancer

South San Francisco, CA -- May 9, 2018 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMblaze370 study evaluating the combination of TECENTRIQ® (atezolizumab) and COTELLIC ® (cobimetinib) did not meet its primary endpoint of overall survival (OS) compared to regorafenib. The study evaluated the combination in people with difficult-to-treat, locally advanced or metastatic colorectal cancer (CRC) whose disease progressed or who were intolerant to at least two systemic chemotherapy regimens.

More than 95 percent of patients in IMblaze370 have microsatellite stable (MSS) tumors and based on the available data, checkpoint inhibitors as monotherapy have not demonstrated clinically meaningful efficacy in MSS mCRC. The results from IMblaze370 were consistent with this prior monotherapy experience, showing that treatment with TECENTRIQ alone did not provide a meaningful clinical benefit compared to regorafenib in this patient population.

Safety for the combination of TECENTRIQ and COTELLIC appeared to be consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. The results from IMblaze370 will be further examined and presented at an upcoming medical meeting.

“While these results are not what we hoped for, we remain committed to applying our deep experience to develop medicines that will improve outcomes for people living with gastrointestinal cancers,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “In particular, we have a number of studies evaluating medicines in colorectal cancer that could play an important role in the treatment of people with this disease in the future.”

Genentech has an extensive clinical trial development program for TECENTRIQ, with more than 50 studies ongoing, including multiple Phase III studies across lung, kidney, skin, breast, colorectal, prostate, ovarian, bladder, blood, liver and head and neck cancers. This includes studies evaluating TECENTRIQ both alone and in combination with other medicines.

About the IMblaze370 study

IMblaze370 is a Phase III, multi-center, open-label, three-arm, randomized study in people with difficult-to-treat locally advanced or metastatic colorectal cancer who have received at least two prior regimens of chemotherapy for metastatic disease. The study compares regorafenib, a standard of care therapy in this setting, to COTELLIC plus TECENTRIQ and TECENTRIQ monotherapy. The study enrolled 363 people who were randomized (2:1:1) to receive:

  • TECENTRIQ plus COTELLIC, or
  • TECENTRIQ, or
  • Regorafenib (control arm)

People in the combination arm received COTELLIC on days 1 to 21 plus TECENTRIQ on day 1 and day 15 in a 28-day cycle, until loss of clinical benefit. People in the monotherapy arm received TECENTRIQ on day 1 of each 21-day cycle, until loss of clinical benefit. People in the control arm received regorafenib on days 1 to 21 in a 28-day cycle, until loss of clinical benefit. The primary endpoint was overall survival. Key secondary endpoints include progression-free survival (PFS), overall response rate (ORR) and duration of response (DoR).

About colorectal cancer

According to the American Cancer Society, colorectal cancer (CRC) is the third most commonly diagnosed cancer in both men and women in the United States and the third leading cause of cancer deaths. In 2018, an estimated 97,000 people will be diagnosed with colorectal cancer and about 50,000 people are expected to die from the disease in the United States. If colorectal cancer spreads (metastasizes) to distant organs, such as the lungs or the liver, five-year survival is 14 percent.

About the TECENTRIQ (atezolizumab) and COTELLIC (cobimetinib) combination

Based on our pre-clinical data and Phase Ib data there was a strong scientific rationale to support the further investigation of TECENTRIQ and COTELLIC. The IMblaze370 data will be further examined in order to better understand the results and presented at an upcoming medical meeting. Genentech is continuing to investigate the TECENTRIQ and COTELLIC combination in other tumor types, including the IMspire150 and IMspire170 studies in melanoma.

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.

About COTELLIC® (cobimetinib)

COTELLIC is a prescription medicine used with Zelboraf for the treatment of people with a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal BRAF gene. COTELLIC is not used to treat melanoma with a normal BRAF gene. COTELLIC was discovered by Exelixis Inc. and was developed by Genentech in collaboration with Exelixis. COTELLIC is also being investigated in combination with several investigational medicines, including TECENTRIQ, in several tumor types such as non-small cell lung cancer, melanoma and colorectal cancer.

TECENTRIQ U.S. Indication (pronounced ‘tē-SEN-trik’)

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, 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

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 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 mucous in the 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 the 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. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TECENTRIQ. If you are able to become pregnant:
    • your healthcare provider should do a pregnancy test before you start treatment with TECENTRIQ
    • You should use an effective method of birth control during your 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
  • muscle pain
  • cough
  • shortness of breath

TECENTRIQ may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if you 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.

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

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

Cotellic U.S. Indication

Cotellic is a prescription medicine that is used with the medicine Zelboraf to treat a type of skin cancer called melanoma:

  • that has spread to other parts of the body or cannot be removed by surgery, and
  • that has a certain type of abnormal “BRAF” gene.

A patient’s healthcare provider will perform a test to make sure that Cotellic is right for the patient. It is not known if Cotellic is safe and effective in children under 18 years of age.

Important Safety Information

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

  • have skin problems or history of skin problems, other than melanoma
  • have bleeding problems, any medical conditions and/or on any medications that increase the risk of bleeding
  • have heart problems
  • have eye problems
  • have liver problems
  • have muscle problems
  • are pregnant or plan to become pregnant. Cotellic can harm an unborn baby.
    • Females who are able to become pregnant should use effective birth control during treatment with Cotellic, and for two weeks after the final dose of Cotellic.
    • Patients should talk to their healthcare provider about birth control methods that may be right for them.
    • Patients should tell their healthcare provider right away if they become pregnant or think they are pregnant during treatment with Cotellic.
  • are breastfeeding or plan to breastfeed. It is not known if Cotellic passes into breast milk. Patients should not breastfeed during treatment with Cotellic and for two weeks after the final dose of Cotellic. Patients should talk to their healthcare provider about the best way to feed their baby during this time.

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Certain medicines may affect the blood levels of Cotellic.

Patients should know the medicines they take and keep a list of them to show their healthcare provider and pharmacist when they get a new medicine.

How should patients take Cotellic?

  • Patients should take Cotellic exactly as their healthcare provider tells them. Patients should not change their dose or stop taking Cotellic unless their healthcare provider tells them to.
  • Patients should take Cotellic one time a day for 21 days, followed by seven days off treatment, to complete a 28-day treatment cycle.
  • Patients can take Cotellic with or without food.
  • If a patient vomits after taking their dose of Cotellic, they should not take an additional dose.
  • If a patient misses a dose of Cotellic, they should take their next dose as scheduled.

What should patients avoid during treatment with Cotellic?

Patients should avoid sunlight during treatment with Cotellic. Cotellic can make a patient’s skin sensitive to sunlight. They may burn more easily and get severe sunburns. To help protect against sunburn:

  • When a patient goes outside, they should wear clothes that protect their skin, including their head, face, hands, arms and legs.
  • They should use lip balm and a broad-spectrum sunscreen with SPF 30 or higher.

What are the possible side effects of Cotellic?

Cotellic may cause serious side effects, including: 

  • Risk of new skin cancers. Cotellic may cause new skin cancers (cutaneous squamous cell carcinoma, keratoacanthoma or basal cell carcinoma).

Patients should check their skin regularly and tell their healthcare provider right away if they have any skin        changes including:

      • new wart
      • skin sore or reddish bump that bleeds or does not heal
      • change in size or color of a mole

A patient’s healthcare provider should check the patient’s skin before they start taking Cotellic, and every two months during treatment with Cotellic. A patient’s healthcare provider may continue to check the patient’s skin for six months after the patient stops taking Cotellic.

A patient’s healthcare provider should also check for cancers that may not occur on the skin. Patients should tell their healthcare provider about any new symptoms that develop during treatment with Cotellic.

  • Bleeding problems. Cotellic can cause serious bleeding problems.

Patients should call their healthcare provider and get medical attention right away if they get any signs of bleeding, including:

  • red or black stools (looks like tar)
  • blood in their urine
  • headaches
  • cough up or vomit blood
  • stomach (abdominal) pain
  • unusual vaginal bleeding
  • dizziness or weakness

 

  • Heart problems . A patient’s healthcare provider should do tests before and during treatment to check the patient’s heart function. Patients should tell their healthcare provider if they get any of these signs and symptoms of heart problems:
    • persistent coughing or wheezing
    • shortness of breath
    • swelling of their ankles and feet
    • tiredness
    • increased heart rate
  • Severe rash. Patients should tell their healthcare provider right away if they get any of these symptoms:
    • a rash that covers a large area of their body
    • blisters
    • peeling skin
  • Eye problems. Patients should tell their healthcare provider right away if they get any of these symptoms:
    • blurred vision
    • partly missing vision or loss of vision
    • see halos
    • any other vision changes

A patient’s healthcare provider should check the patient’s eyes if the patient notices any of the symptoms above.

  • Liver problems. A patient’s healthcare provider should do blood tests to check the patient’s liver function before and during treatment. Patients should tell their healthcare provider right away if they get any of these symptoms:
    • yellowing of their skin or the white of their eyes
    • dark or brown (tea color) urine
    • nausea or vomiting
    • feeling tired or weak
    • loss of appetite
  • Muscle problems (rhabdomyolysis). Cotellic can cause muscle problems that can be severe. Treatment with Cotellic may increase the level of an enzyme in the blood called creatine phosphokinase (CPK) and may be a sign of muscle damage. A patient’s healthcare provider should do a blood test to check the patient’s levels of CPK before and during treatment. Patients should tell their healthcare provider right away if they get any of these symptoms:
    • muscle aches or pain
    • muscle spasms and weakness
    • dark, reddish urine
  • Skin sensitivity to sunlight (photosensitivity). Skin sensitivity to sunlight during treatment with Cotellic is common and can sometimes be severe. Patients should tell their healthcare provider if they get any of these symptoms:
    • red, painful, itchy skin that is hot to touch
    • sun rash
    • skin irritation
    • bumps or tiny papules
    • thickened, dry, wrinkled skin

See “What should patients avoid during treatment with Cotellic?” for information on protecting the skin during treatment with Cotellic.

The most common side effects of Cotellic include:

  • diarrhea
  • nausea
  • fever
  • vomiting

A patient’s healthcare provider will take blood tests during treatment with Cotellic. The most common changes to blood tests include:

  • increased blood levels of liver enzymes (GGT, ALT or AST)
  • increased blood level of enzyme from muscle (creatine phosphokinase)
  • decreased blood level of phosphate, sodium or potassium
  • increased blood level of liver or bone enzyme (alkaline phosphatase)
  • decreased blood level of a type of white blood cell (lymphocyte)

These are not all the possible side effects of Cotellic. Patients should call their doctor for medical advice about side effects. Patients may report side effects to FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835-2555.

Please see Full Cotellic Prescribing Information and Patient Information for additional Important Safety Information at http://www.cotellic.com.

About Genentech in Personalized Cancer Immunotherapy

For more than 30 years, Genentech has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever to bring personalized cancer immunotherapy (PCI) to people with cancer. The goal of PCI is to provide each person with a treatment tailored to harness his or her own immune system to fight cancer. Genentech is studying more than 20 investigational medicines, 10 of which are in clinical trials. In every study we are evaluating biomarkers to identify which people may be appropriate candidates for our medicines. For more information visit http://www.gene.com/cancer-immunotherapy.

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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