Vemurafenib

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the Phase III IMvigor011 study evaluating Tecentriq® (atezolizumab) as an adjuvant treatment for people with muscle-invasive bladder cancer (MIBC) who are at risk of recurrence after surgery (cystectomy) and have detectable circulating tumor DNA (ctDNA). In this ctDNA-guided setting, Tecentriq reduced the risk of death (overall survival, OS) by 41% and the risk of disease recurrence or death (disease-free survival, DFS) by 36%, both compared with placebo. This ctDNA-guided approach, using Natera’s Signatera™ ctDNA Molecular Residual Disease (MRD) test, spared people at low risk of recurrence from unnecessary treatment and side effects. The safety profile was consistent with previous studies of Tecentriq. These results are being presented as part of the Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2025. They will also be discussed with health authorities, including the U.S. Food and Drug Administration. “These clinically meaningful results show that Tecentriq helped people with muscle-invasive bladder cancer live longer and without their disease returning,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “The use of serial ctDNA testing to detect molecular residual disease may also advance bladder cancer treatment by combining a precision diagnostic with cancer immunotherapy.” “Even after surgery, most people with muscle-invasive bladder cancer will face the physical and emotional toll of further treatment,” said Thomas Powles, lead principal investigator of IMvigor011, professor of genitourinary oncology; chair of Barts Cancer Centre at St. Bartholomew's Hospital. “These results indicate that with Signatera ctDNA testing, we may be able to identify those at risk of recurrence who could benefit from adjuvant atezolizumab treatment and spare others from unnecessary therapy, paving the way for a more personalized treatment approach.” At median follow up of 16.1 months, median DFS was 9.9 months in the Tecentriq arm versus 4.8 months in the placebo arm (stratified hazard ratio [HR]=0.64; 95% CI: 0.47-0.87, p=0.0047). Median OS was 32.8 months in the Tecentriq arm versus 21.1 months in the placebo arm (HR=0.59; 95% CI: 0.39-0.90, p=0.0131). People who persistently tested for no detectable ctDNA had low risk of recurrence. More than 150,000 people worldwide are diagnosed with MIBC each year. It is an aggressive type of cancer, with poor long-term outcomes and high treatment burden. Despite this, personalized treatment approaches lag behind other cancer types. ctDNA-guided treatment could change this, by helping healthcare professionals tailor treatment more precisely to improve clinical benefit and reduce unnecessary intervention. About the IMvigor011 study IMvigor011 [NCT04660344] is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with Tecentriq® (atezolizumab) compared with placebo in participants with muscle-invasive bladder cancer (MIBC) who are circulating tumor DNA (ctDNA)-positive and are at risk of recurrence following cystectomy. IMvigor011 utilized Natera’s Signatera™ as the clinical trial assay. This personalized ctDNA test for the detection of MRD is currently under review by the FDA for use as a companion diagnostic. 761 people participated in the surveillance phase of IMvigor011 and those with positive Signatera tests (250 people) joined the treatment phase, where they received either Tecentriq or placebo. The primary endpoint is investigator-assessed disease-free survival (DFS). Secondary endpoints include overall survival (OS) and tolerability, amongst others. About Tecentriq® (atezolizumab) Tecentriq (atezolizumab) is a monoclonal antibody designed to bind with a protein called PD-L1, which is 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. What is Tecentriq? Tecentriq is a prescription medicine used to treat: Adults with a type of lung cancer called non-small cell lung cancer (NSCLC). Adults with a type of lung cancer called “extensive stage small cell lung cancer (SCLC)”, which is SCLC that has spread or grown. Adults with a type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq may be used with the medicine bevacizumab when your liver cancer: Adults with a type of skin cancer called melanoma. Tecentriq may be used with the medicines cobimetinib and vemurafenib when your melanoma: Adults and children 2 years of age and older with a type of soft tissue tumor (cancer) called alveolar soft part sarcoma (ASPS). Tecentriq may be used when your sarcoma: It is not known if Tecentriq is safe and effective when used: Important Safety Information What is the most important information about Tecentriq? Tecentriq can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended. Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including: Lung problems cough shortness of breath chest pain Intestinal problems diarrhea (loose stools) or more frequent bowel movements than usual stools that are black, tarry, sticky, or have blood or mucus severe stomach-area (abdomen) pain or tenderness Liver problems yellowing of your skin or the whites of your eyes severe nausea or vomiting pain on the right side of your stomach area (abdomen) dark urine (tea colored) bleeding or bruising more easily than normal Hormone gland problems headaches that will not go away or unusual headaches eye sensitivity to light eye problems rapid heartbeat increased sweating extreme tiredness weight gain or weight loss feeling more hungry or thirsty than usual urinating more often than usual hair loss feeling cold constipation your voice gets deeper dizziness or fainting changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness Kidney problems decrease in your amount of urine blood in your urine swelling of your ankles loss of appetite Skin problems rash itching skin blistering or peeling painful sores or ulcers in mouth or nose, throat, or genital area fever or flu-like symptoms swollen lymph nodes Problems can also happen in other organs. These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Call or see your healthcare provider right away for any new or worse signs or symptoms, including: Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight Persistent or severe muscle pain or weakness, muscle cramps Low red blood cells, bruising Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: chills or shaking itching or rash flushing shortness of breath or wheezing dizziness feeling like passing out fever back or neck pain Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Tecentriq. Your healthcare provider will monitor you for these complications. Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Tecentriq. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tecentriq if you have severe side effects. Before you receive Tecentriq, tell your healthcare provider about all of your medical conditions, including if you: have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus have received an organ transplant have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic) have received radiation treatment to your chest area have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome are pregnant or plan to become pregnant. Tecentriq can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Tecentriq. Females who 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. 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 your breast milk. Do not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of Tecentriq when used alone include: Feeling tired or weak decreased appetite nausea cough shortness of breath The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include: feeling tired or weak nausea hair loss constipation diarrhea decreased appetite The most common side effects of Tecentriq when used in hepatocellular carcinoma (HCC) with bevacizumab include: high blood pressure feeling tired or weak too much protein in the urine The most common side effects of Tecentriq when used in melanoma with cobimetinib and vemurafenib include: skin rash joint, muscle, or bone pain feeling tired or weak liver injury fever nausea itching swelling of legs or arms mouth swelling (sometimes with sores) low thyroid hormone levels sunburn or sun sensitivity Tecentriq may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility. These are not all the possible side effects of Tecentriq. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555. Please see full Prescribing Information and Medication Guide for additional Important Safety Information. About Genentech in cancer immunotherapy To learn more about Genentech’s scientific-led approach to cancer immunotherapy, please follow this link: https://www.gene.com/cancer-immunotherapy. About Genentech Founded nearly 50 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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