Wednesday, Sep 5, 2018

Genentech to Present New Data from Its Extensive Lung Cancer Program at the 2018 World Conference on Lung Cancer (WCLC)

New and updated pivotal data from the TECENTRIQ lung program, including overall survival (OS) and progression-free survival (PFS) results from Phase III IMpower133 study in extensive-stage small cell lung cancer

New integrated pivotal results for entrectinib in ROS1 fusion-positive non-small cell lung cancer, including global Phase II STARTRK-2 basket study

South San Francisco, CA -- September 5, 2018 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new data from its broad clinical development program across different types of lung cancer will be presented at the International Association for the Study of Lung Cancer (IASLC) 2018 World Conference on Lung Cancer (WCLC), taking place from September 23-26 in Toronto, Canada. Ten abstracts have been accepted, including three ‘late breakers’ and five oral presentations.

“We look forward to presenting new data from our comprehensive lung cancer program, including new immunotherapy and targeted treatment strategies across different types of lung cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are particularly pleased to be sharing positive TECENTRIQ data in extensive-stage small cell lung cancer, which has seen limited progress in treatment over the last two decades, as well as new pivotal data for our investigational therapy entrectinib for the treatment of ROS1 fusion-positive lung cancer.”

Key presentations 

Progression-free survival (PFS) and overall survival (OS) data from the Phase III IMpower133 study of TECENTRIQ^® plus chemotherapy (carboplatin and etoposide) for the initial (first-line) treatment of people with extensive-stage small cell lung cancer (ES-SCLC) will be presented in the Presidential Symposium. These are the first positive survival data from a Phase III study with an immunotherapy-based combination in the initial treatment of ES-SCLC.

PFS and OS data will be presented from the Phase III IMpower132 study investigating TECENTRIQ plus pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) in the initial treatment of people with advanced non-squamous non-small cell lung cancer (NSCLC). The IMpower132 and IMpower133 data will be featured as part of WCLC’s official press program on Monday, September 24 and Tuesday, September 25, respectively.

Additionally, results from a Phase Ib study investigating Tarceva^® plus TECENTRIQ in tyrosine kinase inhibitor (TKI)-naïve people with EGFR mutation-positive NSCLC will also be presented.

New pivotal results of entrectinib, an investigational oral treatment for people with locally advanced or metastatic ROS1 fusion-positive NSCLC, from a pooled analysis including the global Phase II STARTRK-2 basket study will be presented. These data have also been selected to be featured in the WCLC press program on Monday, September 24.

Follow Genentech on Twitter via @Genentech and keep up to date with WCLC 2018 congress news and updates by using the hashtag #WCLC2018.

For more information on Genentech’s approach to cancer, visit http://www.gene.com.

Overview of key presentations featuring Genentech medicines at WCLC 2018 

Medicine	Abstract title	Abstract number
Entrectinib	Efficacy and safety of entrectinib in locally advanced or metastatic ROS1 fusion-positive NSCLC	OA02.01 Oral Monday, Sept. 24 10:30 – 10:40 a.m. EDT
TECENTRIQ (atezolizumab)	IMpower133: Primary PFS, OS and safety in a Phase 1/3 study of 1L atezolizumab plus carboplatin and etoposide in extensive-stage SCLC	PL02.07 Oral Tuesday, Sept. 25 9:00 – 9:10 a.m. EDT
TECENTRIQ (atezolizumab)	IMpower132: PFS, OS and safety results of 1L atezolizumab plus carboplatin/cisplatin plus pemetrexed in stage IV non-squamous NSCLC	OA05.07 Oral Monday, Sept. 24 2:35 – 2:45 p.m. EDT
TECENTRIQ (atezolizumab)	Comprehensive peripheral blood immunophenotyping and T-cell clonal analysis during neoadjuvant immunotherapy with atezolizumab in NSCLC	MA04.10 Mini Oral Monday, Sept. 24 2:35 – 2:40 p.m. EDT
TECENTRIQ (atezolizumab)	Neoadjuvant atezolizumab in resectable non-small cell lung cancer (NSCLC): updated results from a multicenter study	MA04.09 Mini Oral Monday, Sept. 24 2:30 – 2:35 p.m. EDT
TECENTRIQ (atezolizumab) Tarceva (erlotinib)	Long-term safety and clinical activity results from a Phase 1b of erlotinib plus atezolizumab in advanced NSCLC	MA15.02 Mini Oral Tuesday, Sept. 25 1:35 – 1:40 p.m. EDT
TECENTRIQ (atezolizumab) Avastin (bevacizumab)	IMpower150: Impact of chemotherapy cycles in 1L metastatic NSCLC in patients treated with atezolizumab and bevacizumab	P1.01-83 Poster Monday, Sept. 24 4:45 – 6:00 p.m. EDT
TECENTRIQ (atezolizumab)	Retrospective descriptive analysis of metformin with atezolizumab in advanced non-small cell lung cancer in the OAK trial	P1.04-33 Poster Monday, Sept. 24 4:45 – 6:00 p.m. EDT
TECENTRIQ (atezolizumab)	IMpower030: Phase III study evaluating neoadjuvant treatment of resectable stage II-IIIB NSCLC with atezolizumab plus chemotherapy	P2.17-27 Poster Tuesday, Sept. 25 4:45 – 6:00 p.m. EDT
TECENTRIQ (atezolizumab)	Cost-effectiveness of atezolizumab for previously treated advanced or metastatic non-small cell lung cancer (NSCLC) in Canada	P3.04-17 Poster Wednesday, Sept. 26 12:00 – 1:00 p.m. EDT

About lung cancer

According to the American Cancer Society, it is estimated that more than 234,000 Americans will be diagnosed with lung cancer in 2018. Lung cancer can be broadly divided into two major types: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). NSCLC is the most prevalent type, accounting for around 85 percent of all lung cancer cases, and SCLC accounting for approximately 15 percent of all cases. It is estimated that approximately 60 percent of lung cancer diagnoses in the United States are made when the disease is in the advanced stages. While the ROS1 gene fusion can be found in any person with NSCLC, young never-smokers have the highest incidence of ROS1-positive NSCLC.

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. 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 if you have any one of the following conditions:
  • you are not able to take chemotherapy that contains a medicine called cisplatin, and your doctor has tested your cancer and found high levels of a specific protein on your cancer called programmed death-ligand 1 (PD-L1), as determined by an FDA-approved test, or
  • you are not able to take chemotherapy that contains any platinum regardless of PD-L1 status on your cancer, 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. Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with TECENTRIQ. If patients 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. 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 they have concerns about fertility.

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

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 Avastin^® (bevacizumab)

Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF) that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize).

Avastin Indications:

• Metastatic colorectal cancer (mCRC)  for first- or second-line treatment in combination with intravenous 5-fluorouracil–based chemotherapy. It is also approved to treat mCRC for second-line treatment, when used with fluoropyrimidine-based (combined with irinotecan or oxaliplatin) chemotherapy, after cancer progresses following a first-line treatment that includes Avastin.
  • Avastin is not approved for use after the primary treatment of colon cancer that has not spread to other parts of the body
•  Advanced nonsquamous non–small cell lung cancer (NSCLC)  in combination with carboplatin and paclitaxel, in people who have not received chemotherapy for their advanced disease
• Metastatic kidney cancer (mRCC)  when used with interferon alfa
• Glioblastoma (GBM)  in adult patients whose cancer has progressed after prior treatment (recurrent or rGBM)
• Advanced cervical cancer (CC)  in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is approved to treat persistent, recurrent, or metastatic cancer of the cervix
• Ovarian cancer (OC).  Avastin, in combination with carboplatin and paclitaxel, followed by Avastin alone, is used for the treatment of patients with advanced (Stage III or IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgery.

Avastin in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (prOC) in women who received no more than two prior chemotherapy treatments.

Avastin, either in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by Avastin alone, is approved for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (psOC)

Possible serious side effects

Everyone reacts differently to Avastin therapy. So, it’s important to know what the side effects are.  Although some people may have a life-threatening side effect, most do not  . Their doctor will stop treatment if any serious side effects occur.

Patients should contact their health care team if there are any signs of these side effects. 

Most serious side effects (not common, but sometimes fatal):

• GI perforation. A hole that develops in the stomach or intestine. Symptoms include pain in the abdomen, nausea, vomiting, constipation, or fever
• Wounds that don’t heal.   A cut made during surgery can be slow to heal or may not fully heal. Avastin should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed
• Serious bleeding.   This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; nosebleeds; and vaginal bleeding. If a patient has recently coughed up blood or had serious bleeding, they should be sure to tell their doctor

Other possible serious side effects

• Abnormal passage in the body.  This type of passage—known as a fistula—is an irregular connection from one part of the body to another and can sometimes be fatal
• Severe high blood pressure.  Blood pressure that severely spikes or shows signs of affecting the brain. Blood pressure should be monitored every 2 to 3 weeks while on Avastin and after stopping treatment
• Kidney problems.  These may be caused by too much protein in the urine and can sometimes be fatal
• Infusion reactions.  These were uncommon with the first dose (less than 3% of patients). 0.2% of patients had severe reactions. Infusion reactions include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headache, tremors, and excessive sweating. The patient’s doctor or nurse will monitor for signs of infusion reactions
• Severe stroke or heart problems.  These may include blood clots, mini-stroke, heart attack, chest pain, and the heart may become too weak to pump blood to other parts of the body (congestive heart failure). These can sometimes be fatal
• Nervous system and vision problems.  Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness

Side effects seen most often

In clinical studies across different types of cancer, some patients experienced the following side effects:

• High blood pressure
• Too much protein in the urine
• Nosebleeds
• Rectal bleeding
• Back pain
• Headache
• Taste change
• Dry skin
• Inflammation of the skin
• Inflammation of the nose
• Watery eyes

Avastin is not for everyone

Patients should talk to their doctor if they are:

• Undergoing surgery.  Avastin should not be used for 28 days before or after surgery and until surgical wounds are fully healed
• Pregnant or think they are pregnant.  Data have shown that Avastin may harm a woman’s unborn baby. Birth control should be used while patients are on Avastin. If Avastin is stopped, patients should keep using birth control for 6 months before trying to become pregnant
• Planning to become pregnant.  Taking Avastin could cause a woman’s ovaries to stop working and may impair her ability to have children
• Breastfeeding.  Breastfeeding while on Avastin may harm the baby and is therefore not recommended during and for 6 months after taking Avastin

Patients should talk with their doctor if they have any questions about their condition or 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.

For full Prescribing Information and Boxed WARNINGS on Avastin please visit http://www.avastin.com.

About Tarceva^® (erlotinib)

Tarceva is a once-daily, oral non-chemotherapy medicine for the treatment of NSCLC whose cancer has spread to other parts of the body and that has certain types of EGFR mutations. It has been shown to inhibit EGFR, a protein involved in the growth and development of cancers. Tarceva is a trademark of OSI Pharmaceuticals, LLC, Farmingdale, NY, USA, an affiliate of Astellas Pharma US, Inc. In the United States, Tarceva is jointly marketed by Astellas and Genentech, a member of the Roche Group.

Tarceva Indication in NSCLC

Metastatic Non-Small Cell Lung Cancer (NSCLC):

• Tarceva is prescribed for the treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.

Limitations of Use:

• Safety and efficacy of Tarceva have not been established in patients with NSCLC whose tumors have other EGFR mutations.
• Tarceva is not recommended for use in combination with platinum-based chemotherapy.

Important Safety Information

The following serious adverse reactions, which may include deaths, have been reported in patients taking Tarceva:  Interstitial Lung Disease (ILD)-like events; Liver and/or kidney problems; Gastrointestinal (GI) perforations (the development of a hole in the stomach, small intestine, or large intestine); Serious skin conditions; Blood, bleeding and clotting problems (stroke); Eye disorders (dry eyes, eye irritation, and damage to the cornea); Bleeding events when taking warfarin or non-steroidal anti-inflammatory drugs (NSAIDs); Pregnancy (women should avoid becoming pregnant and avoid breastfeeding while taking Tarceva).

Patients should call their doctor right away if they have these signs or symptoms:  Serious or ongoing diarrhea, nausea (feeling sick to the stomach), loss of appetite, or vomiting; New or worsening shortness of breath or cough; Eye irritation; New or worsening rash, blistering or skin peeling; Any changes in smoking habits.

The most common serious side effects include:

Diarrhea, weakness, rash, cough, shortness of breath, loss of appetite, nausea, and vomiting.

Patients should call their healthcare provider 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. 

For full prescribing information, please call 1-877-TARCEVA or visit http://www.tarceva.com

About entrectinib 

Entrectinib (RXDX-101) is an investigational oral medicine in development for the treatment of locally advanced or metastatic solid tumors that harbor NTRK1/2/3 or ROS1 fusions. It is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRKA/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer. Entrectinib can block ROS1 and NTRK kinase activity and may result in the death of cancer cells with ROS1 or NTRK fusions. Entrectinib is being investigated across a range of solid tumor types, including NSCLC, pancreatic cancer, sarcomas, thyroid cancer, salivary cancer, gastrointestinal stromal tumors (GIST) and cancers of unknown primary (CUP).

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 in Lung Cancer

Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have four approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

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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