Divarasib

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that it will present more than 30 abstracts across more than 10 cancer types at the European Society for Medical Oncology (ESMO) Congress 2025, held October 17-21, 2025 in Berlin, Germany. The data underscore Genentech’s commitment to deliver transformative medicines for some of the most challenging cancer types, including breast cancers, lung cancers, gastrointestinal and genitourinary cancers. Key presentations include: Giredestrant: Primary results from the Phase III evERA Breast Cancer study, the first positive head-to-head Phase III trial investigating an all-oral selective estrogen receptor (ER) degrader-containing regimen versus a standard of care combination in the post-cyclin-dependent kinase inhibitor setting for people with ER-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. The study met both co-primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival in both the intention-to-treat and ESR1 -mutated populations. Data will be presented as a late-breaking oral abstract. Tecentriq: Results from the IMvigor011 trial, the first global Phase III study pioneering a circulating tumor DNA (ctDNA)-guided approach to post-surgery treatment in muscle-invasive bladder cancer (MIBC). Topline results show that people who had detectable ctDNA and were treated with Tecentriq ® (atezolizumab) had statistically significant and clinically meaningful improvements in disease-free survival (DFS) and overall survival (OS). Data will be presented as part of the Presidential Symposium. Alecensa: Final OS data from the pivotal ALEX study of Alecensa ® (alectinib). Alecensa is an established first-line treatment and a standard of care for people with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Data will be presented as a late-breaking oral abstract and published simultaneously in the Annals of Oncology . Alecensa: Updated results from the Phase III ALINA study, reinforcing the role of adjuvant Alecensa as the standard of care for patients with resected ALK-positive NSCLC. After a median follow-up of approximately four years, Alecensa DFS data compared with chemotherapy will be presented. Overview of key presentations featuring Genentech medicines: Medicine Abstract title Abstract number/presentation details Breast cancer Giredestrant Giredestrant (GIRE), an oral selective estrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2- aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the Phase III evERA BC trial #LBA16 late-breaking oral Proffered paper session 1: Breast cancer, metastatic Saturday 18 October 2025 10:15-10:25 CEST Preoperative window-of-opportunity study with giredestrant or tamoxifen (tam) in premenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) and Ki67≥10% early breast cancer (EBC): the EMPRESS study (IIS: MEDSIR)* #294MO mini oral Mini oral session: Breast cancer, early stage Sunday 19 October 2025 10:50-10:55 CEST Giredestrant plus Itovebi™ (inavolisib) Interim analysis of giredestrant (GIRE) + inavolisib (INAVO) in MORPHEUS breast cancer (BC): A Phase Ib/II study of GIRE treatment (rx) combinations in patients (pts) with estrogen receptor-positive (ER+), HER2-negative, locally advanced/metastatic BC (LA/mBC) #508P poster Poster session: Breast cancer, metastatic Monday 20 October 2025 12:00-17:30 CEST Itovebi Phase I/Ib trial of inavolisib (INAVO) + pertuzumab (P) + trastuzumab (H) for PIK3CA-mutated (mut), HER2-positive advanced breast cancer (HER2+ aBC) #548P poster Poster session: Breast cancer, metastatic Monday 20 October 2025 12:00-17:30 CEST Genitourinary cancer Tecentriq® (atezolizumab) IMvigor011: a Phase III trial of circulating tumor (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer #LBA8 late-breaking oral Presidential Symposium III Monday 20 October 2025 16:30-16:42 CEST Lung cancer Alecensa® (alectinib) Final overall survival (OS) and safety analysis of the Phase III ALEX study of alectinib vs crizotinib in patients with previously untreated, advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC) #LBA73 late-breaking oral Proffered paper session: NSCLC metastatic Friday 17 October 2025 17:06-17:16 CEST Updated results from the Phase III ALINA study of adjuvant alectinib vs chemotherapy (chemo) in patients (pts) with early-stage ALK+ non-small cell lung cancer (NSCLC) #1787MO mini oral Mini oral session 2: Non-metastatic NSCLC Monday 20 October 2025 14:50-14:55 CEST Tecentriq Patterns of disease progression (PD) and efficacy associated with tumor burden from the Phase III IMforte study of lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in ES-SCLC #2762MO mini oral Mini Oral session 1: Non-metastatic NSCLC Saturday 18 October 2025 17:15-17:20 CEST Gastrointestinal cancer Tecentriq (IIS: NCI, Alliance)** Clinical outcome of patients (pts) with sporadic vs Lynch syndrome-related stage III colon carcinoma (CC) with deficient mismatch repair (dMMR) treated in a randomized trial of adjuvant FOLFOX alone or combined with atezolizumab (atezo; anti-PD-L1) #752P poster Poster session: Colorectal cancer Sunday 19 October 2025 Divarasib Single-agent divarasib experience in patients with KRAS G12C-positive pancreatic adenocarcinoma (panc), cholangiocarcinoma (cholangio), and other solid tumors #927MO mini oral Mini oral session: Developmental therapeutics Friday 17 October 2025 17:00-17:05 CEST * Investigator Initiated Study (IIS). The study is sponsored by MEDSIR and supported by Genentech, a member of the Roche Group. ** Investigator Initiated Study (IIS). The study is sponsored by the National Cancer Institute (NCI), conducted by the Alliance for Clinical Trials in Oncology and supported by Genentech, a member of the Roche Group. What is Itovebi? Itovebi® (inavolisib) is a prescription medicine used in combination with the medicines palbociclib and fulvestrant to treat adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of the body (metastatic), and has come back after hormone (endocrine) therapy. Your healthcare provider will test your cancer for abnormal PIK3CA genes to make sure that Itovebi is right for you. It is not known if Itovebi is safe and effective in children. Important Safety Information What are the possible side effects of Itovebi? Itovebi may cause serious side effects, including: High blood sugar levels (hyperglycemia). High blood sugar is common with Itovebi and may be severe or fatal. Untreated severe hyperglycemia can lead to a condition called diabetic ketoacidosis that can happen in people treated with Itovebi. Diabetic ketoacidosis is a serious condition that requires treatment in a hospital and that can lead to death. Your healthcare provider will monitor your blood sugar levels before you start and during treatment with Itovebi. Your blood sugar levels may be monitored more often if you have a history of Type 2 diabetes. Your healthcare provider may also ask you to self-monitor and report your blood sugar levels at home. This will be required more frequently in the first 4 weeks of treatment. If you are not sure how to test your blood sugar levels, talk to your healthcare provider. You should stay well-hydrated during treatment with Itovebi. Tell your healthcare provider right away if you develop symptoms of high blood sugar, including: difficulty breathing nausea and vomiting (lasting more than 2 hours) stomach pain excessive thirst dry mouth more frequent urination than usual or a higher amount of urine than normal blurred vision unusually increased appetite weight loss fruity-smelling breath flushed face and dry skin feeling unusually sleepy or tired confusion difficulty breathing nausea and vomiting (lasting more than 2 hours) stomach pain excessive thirst dry mouth more frequent urination than usual or a higher amount of urine than normal blurred vision unusually increased appetite weight loss fruity-smelling breath flushed face and dry skin feeling unusually sleepy or tired confusion Mouth sores (stomatitis). Mouth sores are common with Itovebi and may be severe. Tell your healthcare provider if you develop any of the following in your mouth: pain redness swelling ulcers pain redness swelling ulcers Diarrhea. Diarrhea is common with Itovebi and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your healthcare provider right away if you develop diarrhea, stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with Itovebi. Your healthcare provider may tell you to drink more fluids or take medicines to treat your diarrhea Your healthcare provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with Itovebi if you develop certain serious side effects. The most common side effects and abnormal blood test results of Itovebi when used in combination with palbociclib and fulvestrant include: decreased white blood cell counts, red blood cell counts, and platelet counts decreased blood levels of calcium, potassium, sodium, and magnesium increased creatinine blood levels tiredness increased blood levels of the liver enzyme alanine transaminase (ALT) nausea rash loss of appetite COVID-19 infection headache Itovebi may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you. These are not all the possible side effects of Itovebi. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (877) 436-3683. Before you take Itovebi, tell your healthcare provider about all of your medical conditions, including if you: have a history of diabetes or high blood sugar have kidney problems are pregnant or plan to become pregnant. Itovebi can harm your unborn baby. Females who are able to become pregnant: Males with female partners who are able to become pregnant: are breastfeeding or plan to breastfeed. It is not known if Itovebi passes into your breastmilk. Do not breastfeed during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with Itovebi. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Please see the full Prescribing Information, including Patient Information, for additional Important Safety Information. Who is Alecensa for? Alecensa is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene: To help prevent lung cancer from coming back in patients after their tumor has been removed by surgery (adjuvant), or As treatment if your lung cancer has spread to other parts of the body (metastatic). Your doctor will perform a test to make sure that Alecensa is right for you. It is not known if Alecensa is safe and effective in children. 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. Your doctor may lower the dose or stop treatment with Alecensa if any side effects occur. Contact your doctor right away if you have any of the following side effects. Alecensa may cause serious side effects, including: Liver problems (hepatotoxicity). Liver problems are common with Alecensa and can be severe. A doctor will do blood tests at least every 2 weeks for the first 3 months, and then 1 time each month and as needed during treatment with Alecensa. Tell your doctor right away if you get 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. Tell your doctor right away if you have any new or worsening symptoms, including trouble breathing, shortness of breath, cough, or fever. Kidney problems. Alecensa may cause very slow heartbeats that can be severe. Your doctor will check your heart rate and blood pressure during treatment with ALECENSA. Tell your doctor right away if you feel dizzy, lightheaded, or if you faint during treatment with ALECENSA. Tell your doctor if you take any heart or blood pressure medicines. 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 if they faint during treatment with Alecensa. Patients taking Alecensa should tell their doctor if they take any heart or blood pressure medicines. Severe muscle pain, tenderness, and weakness (myalgia). Muscle problems are common with Alecensa and can be severe. Your doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with Alecensa. Tell your doctor right away if you 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. Breakdown of healthy red blood cells earlier than normal (hemolytic anemia). Hemolytic anemia can happen in some people who take Alecensa. If this happens, you may not have enough healthy red blood cells. Your doctor may temporarily stop Alecensa and do blood tests, if needed, to check for this problem. If you develop hemolytic anemia, your doctor may either restart you on Alecensa at a lower dose when the hemolytic anemia goes away, or may stop your treatment with Alecensa. Tell your doctor right away if you experience yellow skin (jaundice), weakness or dizziness, or shortness of breath. What should I tell my doctor before taking ALECENSA? Before you take Alecensa, tell your doctor about all of your medical conditions, including if you: 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. Females who are able to become pregnant: Males who have female partners that are able to become pregnant should use effective birth control (contraception) during treatment with Alecensa and for 3 months after the last dose of Alecensa Are breastfeeding or plan to breastfeed. It is not known if Alecensa passes into your breast milk. Do not breastfeed during treatment with Alecensa and for 1 week after the last dose of Alecensa. Talk to your doctor about the best way to feed your baby during this time Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. What should I avoid while taking Alecensa? Avoid spending time in the sunlight during treatment with Alecensa and for 7 days after the final dose of Alecensa. Your skin may be sensitive to the sun (photosensitivity) and you may burn more easily and get severe sunburns. Use sun protecting measures, such as sunscreen and lip balm with SPF 50 or greater to help protect against sunburn. The most common side effects of Alecensa include: constipation tiredness swelling in hands, feet, ankles, face, and eyelids rash cough These are not all of the possible side effects of Alecensa. For more information, ask your doctor or pharmacist. Call your 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. Please see additional Important Safety Information in full Prescribing Information, including Patient Information. What is Tecentriq? Tecentriq is a prescription medicine used to treat: Adults with a type of lung cancer called “extensive stage small cell lung cancer (SCLC)”, which is SCLC that has spread or grown has not progressed after first treatment with TECENTRIQ or atezolizumab and hyaluronidase-tqjs and the chemotherapy medicines carboplatin and etoposide. It is not known if Tecentriq is safe and effective when used: In children for the treatment of SCLC. 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. 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 in lung cancer with other anti-cancer medicines include: feeling tired or weak Nausea hair loss constipation diarrhea decreased appetite 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 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.