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Genentech to Present New Positive Data from its Broad Cancer Immunotherapy Program and Across a Wide Range of Cancers

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new results from a number of studies across its industry-leading oncology portfolio of approved and investigational medicines will be presented at the European Society for Medical Oncology (ESMO) 2018 Congress, taking place from October 19-23 in Munich, Germany. These data include positive Phase III results from Genentech’s cancer immunotherapy development program across multiple tumor types, positive Alecensa® (alectinib) data from the Phase III ALESIA study and new pivotal data for entrectinib, a tumor-agnostic investigational medicine that targets NTRK gene fusion-positive solid tumors.

“We look forward to presenting the first positive Phase III study of a cancer immunotherapy combination in breast cancer, which showed encouraging results for Tecentriq plus nab-paclitaxel in people with metastatic triplenegative breast cancer, specifically in the PD-L1-positive population,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We will also share new data from our pivotal analysis of entrectinib for people with NTRK gene fusion-positive solid tumors, an example of our continued commitment to developing next-generation personalized treatments.”

Follow Genentech on Twitter via @genentech and keep up to date with ESMO 2018 Congress news and updates by using the hashtag #ESMO18.

Key Presentations

Breast cancer:

Primary results will be presented from the positive, Phase III, randomized IMpassion130 study investigating Tecentriq® plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) as an initial (first-line) treatment for people with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC), an aggressive type of the disease, which currently has limited treatment options. Abstract LBA1_PR (Presidential Symposium 1) – Saturday, October 20, 4:30 – 4:45 p.m. CEST: Hall A2 – Room 18

As reported earlier this year by Genentech, the combination of Tecentriq plus chemotherapy (nab-paclitaxel) significantly reduced the risk of disease worsening or death (progression-free survival, PFS) in the intention-to-treat and the PD-L1-positive populations, and showed an encouraging overall survival (OS) improvement at this interim analysis in people whose disease expresses the PD-L1 protein, a subgroup determined by PD-L1 biomarker testing.

Data from the IMpassion130 study will also be featured as part of ESMO’s press program on Saturday, October 20.

Tumor-agnostic:

Pivotal data from the positive Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA trials will be presented on entrectinib (RXDX-101) for the treatment of people with NTRK gene fusion-positive solid tumors. Abstract LBA17 (oral) – Sunday, October 21, 11:24 – 11:36 a.m. CEST: Hall B3 – Room 22

Molecular profiling and next-generation sequencing will play a critical role in identifying people most likely to benefit from entrectinib. Genentech is combining comprehensive genomic profiling with precision medicines, like entrectinib, in order to offer patients more personalized healthcare solutions.

Entrectinib has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of NTRK gene fusion-positive, locally advanced or metastatic solid tumors in adult and pediatric patients who have either progressed following prior therapies or have no acceptable standard therapies.

Lung cancer:

Key data to be presented at ESMO cover advances from Genentech’s lung cancer program, including a combination approach using the cancer immunotherapy Tecentriq with targeted therapies and a range of different chemotherapies.

OS and PFS data will be presented for the first time from the positive Phase III IMpower130 study, a multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and nab-paclitaxel) versus chemotherapy (carboplatin and nab-paclitaxel) alone for advanced non-squamous non-small cell lung cancer (NSCLC). Abstract LBA53 (oral) – Monday, October 22, 9:15 – 9:30 a.m. CEST: Hall A1 – Room 17

PFS data will also be presented for the first time from the positive Phase III ALESIA study, a randomized, multicenter, open-label study evaluating the efficacy and safety of Alecensa versus crizotinib in Asian patients with treatment-naive anaplastic lymphoma kinase (ALK)-positive advanced NSCLC. Abstract LBA10 (Presidential Symposium 3) – Monday, October 22, 5:30 – 5:45 p.m. CEST: Hall A2 – Room 18

Liver cancer:

Updated data will be presented from a Phase Ib study assessing the safety and clinical activity of the combination of Tecentriq and Avastin® (bevacizumab) as treatment for patients with unresectable or advanced hepatocellular carcinoma (HCC). HCC is an aggressive cancer with limited treatment options and a major cause of cancer deaths worldwide. Earlier this summer the FDA granted BTD for Tecentriq in combination with Avastin as an initial (first-line) treatment for people with advanced or metastatic HCC. Data at ESMO include longer follow-up and data from patients with hepatitis B virus, a major driver of the disease. Abstract LBA26 (oral) – Sunday, October 21, 11:54 a.m. – 12:09 p.m. CEST: Hall A1 – Room 17

Overview of key data featuring Genentech medicines at ESMO 2018

Tumor Abstract title Abstract number
Breast IMpassion130: Results from a global, randomised, double-blind, phase 3 study of atezolizumab (atezo) + nab-paclitaxel (nab-P) vs placebo + nab-P in treatment-naive, locally advanced or metastatic triple-negative breast cancer (mTNBC)

Abstract LBA1_PR (Presidential Symposium)
Saturday, October 20
4:30 – 4:45 p.m. CEST
Hall A2 – Room 18

Subcutaneous trastuzumab (H SC) with intravenous pertuzumab (P IV) and docetaxel (D IV) in HER2-positive advanced breast cancer (BC): MetaPHER second interim analysis

Abstract 323P (Poster)
Monday, October 22
12:45 – 1:45 p.m. CEST
Hall A3 – Poster Area

Tumor-agnostic Efficacy and safety of entrectinib in patients with NTRK fusion-positive (NTRK-fp) tumors: pooled analysis of STARTRK-2, STARTRK-1 and ALKA-372-001

Abstract LBA17 (Oral)
Sunday, October 21
11:24 – 11:36 a.m. CEST
Hall B3 – Room 22

Pan-cancer assessment of BRCA1/2 genomic alterations (GAs) by comprehensive genomic profiling (CGP) of tissue and circulating tumor DNA (ctDNA)

Abstract 51O (Oral)
Saturday, October 20
9:54 – 10:06 a.m. CEST
ICM – Room 14b

Clinical and analytical validation of an FDA approved comprehensive genomic profiling (CGP) assay incorporating multiple companion diagnostics for targeted and immunotherapies

Abstract 79P (Poster)
Saturday, October 20
12:30 – 1:30 p.m. CEST
Hall A3 – Poster Area

Lung IMpower130: Progression-free survival (PFS) and safety analysis from a randomised phase 3 study of carboplatin + nab-paclitaxel (CnP) with or without atezolizumab (atezo) as first-line (1L) therapy in advanced non-squamous NSCLC

Abstract LBA53 (Oral)
Monday, October 22
9:15 – 9:30 a.m. CEST
Hall A1 – Room 17

Primary results of ALESIA: A randomised, phase III, open-label study of alectinib vs crizotinib in Asian patients with treatment-naïve ALK+ advanced NSCLC

Abstract LBA10 (Presidential Symposium)
Monday, October 22
5:30 – 5:45 p.m. CEST
Hall A2 – Room 18

IMpower132: efficacy of atezolizumab (atezo) + carboplatin (carbo)/cisplatin (cis) + pemetrexed (pem) as 1L treatment in key subgroups with stage IV non-squamous non-small cell lung cancer (NSCLC)

Abstract LBA54 (Oral)
Monday, October 22
9:30 – 9:45 a.m. CEST
Hall A1 – Room 17

IMpower131: Progression-free survival (PFS) and overall survival (OS) analysis of a randomised Phase III study of atezolizumab + carboplatin + paclitaxel or nab-paclitaxel vs carboplatin + nab-paclitaxel in 1L advanced squamous NSCLC

Abstract LBA65 (Poster Discussion)
Sunday, October 21
4:45 – 5:45 p.m. CEST
ICM – Room 13

IMpower150: clinical safety, tolerability and immune-related adverse events in a Phase III study of atezolizumab (atezo) + chemotherapy (chemo) ± bevacizumab (bev) vs chemo + bev in 1L nonsquamous NSCLC

Abstract 1386PD (Poster Discussion)
Sunday, October 21
4:45 – 5:45 p.m. CEST
ICM – Room 13

Analytic validation of tumor mutational burden as a companion diagnostic for combination immunotherapy in non-small cell lung cancer

Abstract 56PD (Poster Discussion)
Saturday, October 20
3:00 p.m. CEST
Hall B4 – Room 19

Kidney IMmotion151: molecular correlates differentiate response to atezolizumab (atezo) + bevacizumab (bev) vs sunitinib (sun) in untreated metastatic renal cell carcinoma (mRCC)

Abstract LBA31 (Oral)
Saturday, October 20
9:15 – 9:27 a.m. CEST
Hall A1 – Room 17

Safety and tolerability of atezolizumab (atezo) plus bevacizumab (bev) vs sunitinib (sun) in untreated metastatic renal cell carcinoma (mRCC): pooled analysis of IMmotion150 and IMmotion151

Abstract 873P (Poster)
Monday, October 22
12:45 – 1:45 p.m. CEST
Hall A3 – Poster Area

Liver Updated safety and clinical activity results from a Phase Ib study of atezolizumab + bevacizumab in hepatocellular carcinoma (HCC)

Abstract LBA26 (Oral)
Sunday, October 21
11:54 a.m. – 12:09 p.m. CEST
Hall A1 – Room 17

Biomarkers Primary efficacy results from B-F1RST, a prospective Phase II trial evaluating blood-based tumour mutational burden (bTMB) as a predictive biomarker for atezolizumab (atezo) in 1L non-small cell lung cancer (NSCLC)

Abstract LBA55 (Oral)
Monday, October 22
9:45 – 10:00 a.m. CEST
Hall A1 – Room 17

Colorectal Fluoropyrimidine (FP) + bevacizumab (BEV) + atezolizumab vs FP/BEV in BRAFwt metastatic colorectal cancer (mCRC): Findings from Cohort 2 of MODUL – a multicentre, randomized trial of biomarker-driven maintenance treatment following first-line induction therapy

Abstract LBA19 (Oral)
Monday, October 22
9:27 – 9:39 a.m. CEST
Hall A2 – Room 18

Bladder A phase II study investigating the safety and efficacy of neoadjuvent atezolizumab in muscle invasive bladder cancer (ABACUS)

(Investigator initiated study)

Abstract 899P (Poster)
Monday, October 22
12:45 – 1:45 p.m. CEST
Hall A3 – Poster Area

Biological features and clinical outcomes in atezolizumab (atezo)-treated patients (pts) with metastatic urothelial cancer (mUC) of the upper vs lower urinary tract (UTUC vs LTUC)

Abstract 902P (Poster)
Monday, October 22
12:45 – 1:45 p.m. CEST
Hall A3 – Poster Area

Abraxane is a registered trademark of Abraxis Bioscience, LLC, a wholly owned subsidiary of Celgene Corporation.

About triple negative breast cancer

Breast cancer is the second most common cancer among women in the United States. According to the American Cancer Society, it is estimated that about 266,000 American women will be diagnosed with invasive breast cancer in 2018, and nearly 41,000 will die from the disease. Approximately 10-20 percent of breast cancers are triple negative breast cancer (TNBC). TNBC is an aggressive form of the disease with a high unmet need. It can be more difficult to treat because it is not sensitive to hormone therapy or medicines that target HER2.

About NTRK gene fusions

Neurotrophic tyrosine receptor kinase (NTRK) fusion-positive cancer occurs when the NTRK1/2/3 genes fuse with other genes, resulting in altered TRK proteins (TrKA/TrKB/TrKC) that can activate signaling pathways involved in proliferation of certain types of cancer. NTRK gene fusions are tumor-agnostic, meaning they are present in tumors irrespective of site of origin. These fusions have been identified in a broad range of solid tumor types, including lung, head and neck, salivary, pancreatic, breast and thyroid. There is a high unmet medical need for treatments for people with life-threatening and hard-to-treat NTRK fusion-positive tumors.

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.

About hepatocellular carcinoma

Hepatocellular carcinoma (HCC) accounts for approximately 75 percent of all liver cancer cases diagnosed in the United States, with more than 20,000 men and more than 5,000 women diagnosed annually. HCC develops predominantly in people with cirrhosis due to chronic hepatitis B or C, and typically presents at an advanced stage where there are limited treatment options.

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: o 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 1-888-8352555.

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 Alecensa® (alectinib)

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

Alecensa U.S. Indication

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

Important Safety Information

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

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

Alecensa may cause serious side effects, including:

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

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

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

  • Trouble breathing
  • Shortness of breath
  • Fever
  • Cough

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

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

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

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

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

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

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

The most common side effects of Alecensa include:

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

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

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

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

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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