Bevacizumab-BVZR

SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reports an update on the Phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq ® (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC). SKYSCRAPER-01 is a global Phase III, randomized, double-blinded study evaluating tiragolumab plus Tecentriq compared to Tecentriq alone in 534 patients with PD-L1-high previously untreated, locally advanced unresectable or metastatic NSCLC. Patients were randomized 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until disease progression, loss of clinical benefit, or unacceptable toxicity. The study did not reach the primary endpoint of overall survival at the final analysis. The overall safety profile observed remained consistent with longer follow-up, and no new safety signals were identified. The detailed data will be presented at a medical meeting in 2025. Genentech continuously reviews its study programs to determine if any adjustments are necessary for the purposes of ongoing research. Genentech will apply the same principles to this program, with additional data from Phase III studies across different settings or tumor types anticipated next year. About tiragolumab Tiragolumab is an investigational immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory immune checkpoint which suppresses the immune response to cancer. 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. Indications Tecentriq is a prescription medicine used to treat adults with: Adults with a type of lung cancer called non-small cell lung cancer (NSCLC). Tecentriq may be used alone as a treatment for their lung cancer: to help prevent their lung cancer from coming back after their tumor(s) has been removed by surgery and they have received platinum-based chemotherapy, and they have stage 2 to 3A NSCLC (patients should talk to their healthcare provider about what these stages mean), and their cancer tests positive for “PD-L1.” Tecentriq may be used alone as their first treatment when their lung cancer: has spread or grown, and their cancer tests positive for “high PD-L1,” and their tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as their first treatment when their lung cancer: has spread or grown, and is a type called “non-squamous NSCLC,” and their tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as their first treatment when their lung cancer: has spread or grown, and is a type called “non-squamous NSCLC,” and their tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq may be used alone when their lung cancer: has spread or grown, and if they have tried chemotherapy that contains platinum, and it did not work or is no longer working. if their tumor has an abnormal “EGFR” or “ALK” gene, they 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 when used in children for the treatment of NSCLC. Important Safety Information What is the most important information about Tecentriq? Tecentriq can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. Patients can have more than one of these problems at the same time. These problems may happen anytime during their treatment or even after their treatment has ended. Patients should call or see their healthcare provider right away if they 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 the skin or the whites of the eyes severe nausea or vomiting pain on the right side of their 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 their voice gets deeper dizziness or fainting changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness Kidney problems decrease in their amount of urine blood in their urine swelling of their 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. Patients should call or see their 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 patients undergo transplantation either before or after being treated with Tecentriq. A healthcare provider will monitor for these complications. Getting medical treatment right away may help keep these problems from becoming more serious . A healthcare provider will check patients for these problems during their treatment with Tecentriq. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may also need to 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 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 their chest area have a condition that affects their nervous system, such as myasthenia gravis or Guillain-Barré syndrome 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. Females who 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. Patients should 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 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 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 about the benefits and side effects of Tecentriq. 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 see http://www.Tecentriq.com for full Prescribing Information and additional Important Safety Information. 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 .

Investigational subcutaneous pembrolizumab and berahyaluronidase alfa, in combination with chemotherapy, demonstrates noninferior pharmacokinetics compared to intravenous KEYTRUDA in combination with chemotherapy in adults with metastatic non-small cell lung cancer Merck to discuss results from MK-3475A-D77 study with regulatory authorities worldwide RAHWAY, NJ, USA I November 19, 2024 I Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the pivotal Phase 3 MK-3475A-D77 trial. The trial is evaluating the noninferiority of subcutaneous administration of pembrolizumab, Merck’s anti-PD-1 therapy, available for intravenous use as KEYTRUDA ® , together with berahyaluronidase alfa, a hyaluronidase variant developed and manufactured by Alteogen Inc. (MK-3475A; “subcutaneous pembrolizumab”), administered with chemotherapy versus intravenous (IV) KEYTRUDA administered with chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC). The Phase 3 trial met its dual primary pharmacokinetic (PK) endpoints. Specifically, subcutaneous pembrolizumab administered every six weeks with chemotherapy demonstrated noninferiority of Area Under the Curve (AUC) exposure of pembrolizumab during the first dosing cycle, and trough concentration (Ctrough) of pembrolizumab measured at steady state, compared to IV KEYTRUDA administered every six weeks in combination with chemotherapy. Additionally, secondary endpoints of efficacy and safety were generally consistent for subcutaneous pembrolizumab administered with chemotherapy compared with IV KEYTRUDA administered with chemotherapy. These results, as well as those from ongoing analyses, will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide. “KEYTRUDA has helped transform the way we treat some of the deadliest forms of cancer, yet we continue to pursue additional innovations that may benefit patients,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “It is very encouraging to see positive Phase 3 results evaluating this fixed-dose combination of subcutaneous pembrolizumab, which was administered, on average, in approximately 2-3 minutes and has the potential to improve the patient experience as well as increase access for patients and healthcare providers compared to intravenous administration. We plan to discuss these results with regulatory authorities worldwide as soon as possible.” In addition to the Phase 3 MK-3475A-D77 trial, Merck’s subcutaneous pembrolizumab clinical development program includes the Phase 3 MK-3475A-F84 trial evaluating subcutaneous pembrolizumab administered alone compared to IV KEYTRUDA alone for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%), as well as the Phase 2 MK-3475A-F65 trial evaluating subcutaneous pembrolizumab administered alone in relapsed or refractory classical Hodgkin lymphoma and relapsed or refractory primary mediastinal large B-cell lymphoma. Merck is also conducting a Phase 2 patient preference study, MK-3475A-F11, evaluating participant-reported preference for subcutaneous pembrolizumab in comparison to IV KEYTRUDA. About MK-3475A-D77 MK-3475A-D77 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT05722015 ) evaluating the subcutaneous administration of pembrolizumab together with berahyaluronidase alfa (also known as ALT-B4) administered every six weeks with chemotherapy compared to IV KEYTRUDA administered every six weeks in combination with chemotherapy for the first-line treatment of adult patients with metastatic NSCLC. The study is designed to assess the dual primary PK endpoints of the AUC of pembrolizumab exposure during the first dosing cycle and the Ctrough of pembrolizumab measured at steady state. Secondary endpoints include additional PK parameters as well as efficacy (objective response rate, duration of response, progression-free survival and overall survival) and safety. The trial enrolled an estimated 378 patients who were randomized (2:1) to receive either subcutaneous pembrolizumab administered with chemotherapy or IV KEYTRUDA in combination with chemotherapy. About KEYTRUDA ® (pembrolizumab) injection, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected KEYTRUDA ® (pembrolizumab) Indications in the U.S. Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. Primary Mediastinal Large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Melanoma KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. Malignant Pleural Mesothelioma KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test. Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval of this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Esophageal Cancer KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: Cervical Cancer KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer. KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. Hepatocellular Carcinoma KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. Biliary Tract Cancer KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). Merkel Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Tumor Mutational Burden-High Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. Merck’s focus on cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit http://www.merck.com.libproxy1.nus.edu.sg/research/oncology . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . SOURCE: Merck