Margetuximab Clinical Trial


It was engineered to increase affinity for CD16A polymorphisms and decrease affinity for FcγRIIB (CD32B), an inh. which is already in phase 3 of development and is very likely to be approved by the FDA given its latest clinical trial's results. MacroGenics, Inc. Margetuximab as the Company's Flagship. 6% (15/28), and a clinical benefit rate of 75. org or fill out this online referral form. If margetuximab is approved, based on SOPHIA data, I believe that this agent could become a valuable treatment option for these patients," said Hope S. MAHOGANY is a Phase 2/3 clinical trial in two modules designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with advanced or metastatic HER2-positive GEJ/GC. Margetuximab is an immune enhancing monoclonal antibody based on MacroGenics’ proprietary Fc Optimization platform. 30, 2019 (GLOBE NEWSWIRE) -- MacroGenics, Inc. Margetuximab is an investigational immune-enhancing monoclonal antibody derived from the Company's proprietary Fc Optimization technology platform. Kantar analyst Katie Stockstill discusses the results of phase 3 SOPHIA trial that were presented on the last day of ASCO 2019. A phase 3 trial of MacroGenics' margetuximab in HER2-positive metastatic breast cancer patients has met its primary endpoint. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced positive results from SOPHIA, the Company's Phase 3 clinical study of margetuximab in. In addition to his clinical practice, Dr. SOPHIA Phase 3 Data Presented at ASCO; Second Interim OS Data Expected in 4Q2019; Plans to Submit BLA in 4Q2019: At the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2019, MacroGenics presented data from SOPHIA, the Phase 3 clinical trial of margetuximab in patients with HER2-positive metastatic breast cancer. Margetuximab is an investigational monoclonal antibody that targets the HER2 oncoprotein. The SOPHIA study (NCT02492711) is a randomized, open-label Phase 3 clinical trial evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive. The EU Clinical Trials Register currently displays 35896 clinical trials with a EudraCT protocol, of which 5892 are clinical trials conducted with subjects less than 18 years old. Margetuximab is under investigation in clinical trial NCT03133988 (Margetuximab Expanded Access Program). Astellas and Seattle Genetics anticipate top-line results from the ongoing Phase II EV-201 study for the first cohort in the first quarter of 2019. MGD013, MGD013 in combination with margetuximab. KADCYLA: EMILIA clinical trial design Efficacy and safety were assessed in HER2+ MBC patients previously treated with trastuzumab and a taxane 1 The EMILIA trial was a large (N=991), Phase III, open-label, randomized trial in patients with HER2-positive (HER2+), unresectable, locally advanced or metastatic breast cancer (MBC). The SOPHIA study is a randomized, openlabel Phase III clinical trial evaluating margetuximab - plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2positive - metastatic breast cancer. Both basic science and clinical trial data are rapidly developing in the use of immunotherapy for breast cancer. DB15044: Tafasitamab. Sequence of anthracyclines and taxanes in the neoadjuvant chemotherapy of HER2-negative breast cancer: Experience of a Brazilian oncological center. Herceptin administration can result in sub-clinical and clinical cardiac failure. MacroGenics, Inc. Biopharmaceutical firm MacroGenics has initiated a Phase II/III clinical trial of margetuximab as a first-line therapy for HER2-positive gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. MAHOGANY (NCT04082364) is a Phase 2/3 clinical trial in two modules designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with advanced or metastatic HER2-positive GEJ/GC. Hawthorne said: “There was a very similar debate that took place when PFS was the only known improved endpoint; ultimately those trials did show an OS benefit and maintenance became a standard of care. By default, cookies are set to “Allow all cookies. Breast Clinical Trials For more information on Breast Clinical Trials, contact the Karmanos Clinical Trials Office at 313-576-9790. The most efficient design of clinical trial is standard two arm randomized-trial comparing with multiarm design according to the Ventz et al publication in JCO. 17, 2019, 02:30 PM. The anti-HER2 antibody improved progression-free survival by more. SOPHIA Phase 3 Data Presented at ASCO; Second Interim OS Data Expected in 4Q2019; Plans to Submit BLA in 4Q2019: At the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2019, MacroGenics presented data from SOPHIA, the Phase 3 clinical trial of margetuximab in patients with HER2-positive metastatic breast cancer. In a pivotal adjuvant breast cancer trial, one patient who developed CHF died of cardiomyopathy. Metabolite Markers — Heard in the Halls: Voices From the 2019 American Society of Clinical Oncology Annual Meeting Elizabeth O'Day, Ph. The SOPHIA clinical trial met the primary. The trial was in a combination of pembrolizumab and was targeting patients suffering from advanced HER2+ gastric carcinoma. MAHOGANY (NCT04082364) is a Phase 2/3 clinical trial in two modules designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with advanced or metastatic HER2-positive GEJ/GC. Margetuximab, also known as MGAH22, is a monoclonal antibody that targets HER2-expressing tumors, including breast, gastroesophageal, bladder, and other cancers. MAHOGANY is a Phase 2/3 clinical trial in two modules designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with advanced or metastatic HER2-positive GEJ/GC. It was given orphan drug status for multiple myeloma by the FDA in December 2016. Margetuximab Expanded Access Program. There was a Phase I, Part 1 trial that is almost over (they recruited HER2+ tumors in cancers other than breast cancer). In addition to his clinical practice, Dr. 0% (21/28) (PMID: 24982373). MacroGenics has initiated a Phase II/III trial of margetuximab as a first-line therapy for HER2-positive gastric cancer or gastroesophageal junction cancer. A second pre-planned interim overall survival (OS) analysis of a Phase 3 clinical trial, SOPHIA, evaluating MacroGenics' (NASDAQ:MGNX) margetuximab, an HER2-targeting monoclonal antibody, plus. 28, 2019 (GLOBE NEWSWIRE) -- Guardant Health and the National Cancer Center Hospital East will present data at the European Society of Medical Oncology (ESMO) conference from a prospective, multi-center phase II clinical trial (TRIUMPH). Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer (SOPHIA) Your Message Will Go To Annabel Castaneda 650-728-7977. Results from a late-stage study showed MacroGenics' experimental drug margetuximab extended progression-free survival in previously treated HER-2 positive metastatic breast cancer patients over Roche's Herceptin, when both were given alongside chemotherapy. About Margetuximab Margetuximab is an investigational Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2 oncoprotein. 25, 2019 (GLOBE NEWSWIRE) -- Zai Lab Limited ZLAB, +4. Those with a low integrated risk of < 5% include the RS 0-10 group irrespective of clinical risk, and 11-25 and low clinical risk –tamoxifen without chemotherapy is an appropriate choice here. 78%, a clinical-stage biopharmaceutical company focused on. If you or a loved one needs information or resources about clinical trials, call our Clinical Trial Information Helpline at 1-877 GO KOMEN (1-877- 465- 6636) or email [email protected] 9m M1SNC a 2 anni 10. MacroGenics' margetuximab beats Herceptin. SOPHIA started in 2015 for MBC HER2+ patients. Breast cancer constitutes one of the most common types of cancer, affecting approximately 232,670 women and 2360 men in the United States in 2014. Clinical Trials Arena is using cookies We use them to give you the best experience. The EU Clinical Trials Register currently displays 35982 clinical trials with a EudraCT protocol, of which 5905 are clinical trials conducted with subjects less than 18 years old. The trial. MacroGenics has been evaluating the drug, margetuximab, in a late. KADCYLA: EMILIA clinical trial design Efficacy and safety were assessed in HER2+ MBC patients previously treated with trastuzumab and a taxane 1 The EMILIA trial was a large (N=991), Phase III, open-label, randomized trial in patients with HER2-positive (HER2+), unresectable, locally advanced or metastatic breast cancer (MBC). That trial will be more about effectiveness of treatment. DB15014: Gremubamab: Gremubamab is under investigation in clinical trial NCT02255760 (Phase 1 Randomized Double-blind Placebo Controlled Study to Evaluate Safety and PK of MEDI3902 in Healthy Adults). Histologically proven, locally advanced unresectable or metastatic solid tumors (or hematologic malignancies, Cohort Expansion only) for whom no approved therapy with demonstrated clinical benefit is available or standard treatment was declined. An evaluation of efficacy, as measured by progression-free survival (PFS) assessed by independent review and overall survival (OS), of margetuximab plus chemotherapy compared with trastuzumab plus chemotherapy in patients with advanced HER2+ breast cancer who have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting, or in case of having received (neo)adjuvant pertuzumab, at least 1 prior line of anti-HER2 directed therapy in the metastatic setting, and who. Combination Margetuximab, INCMGA00012, MGD013, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer (MAHOGANY) October 2, 2019; Detection of Gastrointestinal Bleeding in Intensive Care Patients Via Biosensor Watch October 2, 2019; Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer October. org or fill out this online referral form. Results from a late-stage study showed MacroGenics' experimental drug margetuximab extended progression-free survival in previously treated HER-2 positive metastatic breast cancer patients over Roche's Herceptin, when both were given alongside chemotherapy. Catenacci is an active basic and clinical researcher, focusing on the treatment of gastroesophageal (esophagus, gastroesophageal junction, and stomach. Based on preclinical data, investigators hypothesized that margetuximab would confer greater clinical benefit in lower binding CD16A-158F carriers because of its. SOPHIA Phase 3 Data Presented at ASCO; Second Interim OS Data Expected in 4Q2019; Plans to Submit BLA in 4Q2019: At the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2019, MacroGenics presented data from SOPHIA, the Phase 3 clinical trial of margetuximab in patients with HER2-positive metastatic breast cancer. There was a Phase I, Part 1 trial that is almost over (they recruited HER2+ tumors in cancers other than breast cancer). A separate cohort will evaluate the combination of MGD013 with margetuximab (anti-HER2 monoclonal antibody) in approximately 12 patients with HER2-positive cancer. Margetuximab is designed to target the HER2 oncoprotein, which is expressed by tumor cells in breast, gastroesophageal, and other solid tumors. Breast cancer (BC) is a complex disease with primary or acquired incurability characteristics in a significant part of patients. network news FALL 2016, VOL. Overall survival (OS) results of a phase III randomized trial of standard-of-care therapy with or without enzalutamide for metastatic hormone-sensitive prostate cancer (mHSPC): ENZAMET (ANZUP 1304), an ANZUP-led international cooperative group trial. MacroGenics is a clinical stage biopharmaceutical company focused on the development of antibody-based therapeutics for the treatment of cancer. Appointments and Referrals Find a Doctor Clinical Trials. 2 The anti-HER2 humanized monoclonal antibody trastuzumab remains a landmark in anticancer drug discovery. MAHOGANY is a Phase 2/3 clinical trial in two modules designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line. Incyte will partner with MacroGenics to develop its Phase I cancer immunotherapy candidate MGA012, through a collaboration that could generate up to $900 million-plus for MacroGenics. • Pursue clinical trial waiver in China • Recommended in China Glioma guidelines based on Level 1 evidence • Abbreviated clinical trial agreed for China • Supported by China national key grants • Category 1 drug • Local manufacturing • Best-in-class PARP franchise • The only next generation, once-daily broad spectrum antibiotic. All trials on the list are supported by NCI. skip to content Rare Cancer News & Clinical Trials » Google - Merkel Cell Cancer » October 25, 2019. Catenacci is an active basic and clinical researcher, focusing on the treatment of gastroesophageal (esophagus, gastroesophageal junction, and stomach. (NASDAQ:MGNX) has presented updated data from its Phase 2 clinical trial of margetuximab. Recently, a press release reported that the phase III trial, comparing the addition to chemotherapy of margetuximab vs trastuzumab in HER2+ mBC patients with progression on prior HER2-targeted treatment, demonstrated a 24%. The Phase 1b portion is designed to determine the safety and tolerability of margetuximab in combination with KEYTRUDA in patients with advanced gastric cancer, while the Phase 2 portion will evaluate the anti-tumor activity of margetuximab in combination with. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). An experimental breast cancer drug from Seattle Genetics is headed for FDA review after the company reported a pivotal clinical trial met its main goals. The SOPHIA clinical trial met the primary endpoint of prolongation of progression-free survival (PFS) in patients treated with the combination of margetuximab plus chemotherapy compared to. Results from the SOPHIA study were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in June 2019. New Patients. The clinical trials on this list are studying Margetuximab. Call the Mercy Medical Research Institute at (417)841-0250 or toll-free 1-866-207-0167 (for those outside the 417 area code) if you are interested in participating in a clinical trial. Novel Anti-HER2 Abs: Margetuximab Mechanism of Action Available Results* Outstanding Ongoing Trials Anti-HER2 antibody that binds with elevated affinity to both the lower and higher affinity forms of CD16A (an Fcγ receptor important for antibody dependent cell-mediated cytotoxicity [ADCC]) *Bang YJ. A clinical trial for this drug is recruiting patients in Montreal, Toronto, and Sault Ste. Margetuximab is an investigational immune-enhancing monoclonal antibody derived from the Company's proprietary Fc Optimization technology platform. Phase 2a clinical trial in. Remarkably, there are ~120 antibody immune checkpoint modulators currently in clinical studies, together comprising ~20% of the total commercial clinical pipeline of antibody therapeutics. MAHOGANY is a phase 2/3 clinical trial in two modules designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with advanced or metastatic HER2-positive GEJ/GC. 4 mg/m2 Day 1 and 8 of a 21-day cycle or Gemcitabine 1000 mg/m2 Day 1 and 8 of a 21-day cycle or Vinorelbine 25-30 mg/m2 Day 1 and 8 of a 21-day cycle Biological: Margetuximab. next month and the American Society of Clinical Oncology’s meeting in Chicago in June. Astellas and Seattle Genetics anticipate top-line results from the ongoing Phase II EV-201 study for the first cohort in the first quarter of 2019. MacroGenics (MGNX - Get Report) shares soared on positive results from Sophia, its late-stage clinical study of the efficacy of margetuximab in patents with HER2-positive metastatic breast cancer. Learn about clinical trials at MD Anderson and search our database for open studies. Clinical Trials Arena is using cookies We use them to give you the best experience. 6 trial comparing adjuvant mFOLFIRINOX to gemcitabine for resected pancreatic adenocarcinoma (PAD) Key efficacy results and clinical implications of the Phase III APACT trial evaluating adjuvant nab paclitaxel/gemcitabine versus gemcitabine alone. It was engineered to increase affinity for CD16A polymorphisms and decrease affinity for FcγRIIB (CD32B), an inh. About Margetuximab Margetuximab is an investigational Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2 oncoprotein. MacroGenics has a diverse portfolio of proprietary product candidates with several clinical trials currently underway or planned for the near future. CEO Scott Koenig has been doing the rounds at the American Society of Clinical Oncology (ASCO) conference in Chicago following release of detailed data from the SOPHIA trial of margetuximab in breast cancer patients who have previously been treated with Herceptin and other similar medicines. A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment. There was a Phase I, Part 1 trial that is almost over (they recruited HER2+ tumors in cancers other than breast cancer). Margetuximab is designed to target the HER2 oncoprotein, which is expressed by tumor cells in breast, gastroesophageal, and other solid tumors. PALLAS is an international clinical trial sponsored by Alliance Foundation Trials, LLC (AFT) and Austrian Breast & Colorectal Cancer Study Group (ABCSG), in cooperation with PrECOG, BIG, GBG, and NSABP, and it is supported by Pfizer Inc. A combination of MacroGenics' HER2 antibody margetuximab and standard chemotherapy is superior to Herceptin (trastuzumab) plus chemotherapy at extending the time to disease progression among advanced and pre-treated breast cancer patients whose tumors are positive for HER2 (human epidermal growth factor receptor 2), a Phase 3 trial shows. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Novartis (NYSE: NVS) announced the FDA placed a partial hold on clinical trials for intrathecal administration of Zolgensma (AVXS-101) following findings from a pre-clinical trial in which animal findings showed dorsal root ganglia (DRG) mononuclear cell inflammation, sometimes accompanied by neuronal cell body degeneration or loss. Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer (SOPHIA) Your Message Will Go To Annabel Castaneda 650-728-7977. "Continuing our focus on execution, in the second half of the year, we are planning to submit the BLA for margetuximab, initiate two registration-directed Phase 2/3 clinical trials, and provide. HER2 targeting is a remarkable example of how a therapeutic strategy can profoundly transform the natural history of a disease. A total of 545 eligible patients were. Combination Margetuximab and Pembrolizumab for Advanced, Metastatic HER2(+) Gastric or Gastroesophageal Junction Cancer The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. clinical trial met the primary endpoint of prolongation of progression-free survival (PFS) in patients treated with the combination of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy. com One-month PFS boost, but certain subgroups may derive more benefit. In the phase I monotherapy clinical trial, margetuximab was well tolerated and active in heavily pretreated HER2-positive breast cancer patients, with 12% patients experiencing partial response (PR) with a median PFS of 5. Margetuximab is an immune enhancing monoclonal antibody based on MacroGenics’ proprietary Fc Optimization platform. MacroGenics (NASDAQ:MGNX) had its target price lowered by analysts at Wedbush from $23. Clinical Trials Austin Cancer Center is always searching for the next great advancement in cancer treatment. Find Non-cancer Clinical Trials; Search In. FOX4 talked to Dr. They are conducting a Phase III clinical trial of margetumixmab. They are conducting a Phase III clinical trial of margetumixmab. Incyte will partner with MacroGenics to develop its Phase I cancer immunotherapy candidate MGA012, through a collaboration that could generate up to $900 million-plus for MacroGenics. On behalf of the more than 5 million Americans living with Alzheimer's and their family members, the Alzheimer's Association is encouraged to learn that Biogen will pursue regulatory approval from the FDA for the investigational drug aducanumab based on Phase 3 clinical trial results from the EMERGE and ENGAGE studies, and other related data. MacroGenics, the clinical-stage biopharmaceutical company out. 78%, a clinical-stage biopharmaceutical company focused on. Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer Clinical Trial of Atezolizumab With Paclitaxel. Shares of Maryland-based MacroGenics fell by nearly 20% Tuesday after its experimental drug for advanced breast cancer showed only a "modest" impact on delaying tumor growth, and questionable efficacy in helping patients live longer. MacroGenics Announces Margetuximab (MGAH22) Phase 1 Data Presentation at ASCO; Initiates Phase 2 Clinical Study to Evaluate Activity of Margetuximab in Patients with Metastatic Breast Cancer. You can either enter one or more word(s) in the basic search box and then click on search, or use the advanced search form. Get more information about eligibility criteria and enrolling in A Phase 3 Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients with HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment at NYU Langone. All trials on the list are supported by NCI. Press View: Provides quick insight on daily drug updates from company and press aggregators websites ; Financial updates on funds raising through public offerings, equity sales, licensing agreements, acquisitions and mergers. MAHOGANY (NCT04082364) is a Phase 2/3 clinical trial in two modules designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first. ROCKVILLE, MD, USA I January 18, 2018 I MacroGenics, Inc. A Phase 3, randomized, multi-center clinical trial (SOPHIA; [NCT02492711][2]) is enrolling patients with metastatic breast cancer, comparing margetuximab plus chemotherapy to trastuzumab plus chemotherapy in patients who have received 1 to 3 lines of therapy for advanced disease. Clinical Trials Accepting Patients. Patients in the OlympiAD trial had HER2-negative gBRCA1- or gBRCA2-mutated breast cancer, which was HR+ or triple negative, and received Lynparza for metastatic disease. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). HER2 is expressed by tumor cells in breast, gastric, gastroesophageal, bladder and other forms of solid tumor cancers, making it a key marker for biologic therapy. NCI's basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials. 演題選定&解説担当:慶應義塾大学泌尿器科学教室講師 小坂威雄氏. Clinical Trials Arena is using cookies We use them to give you the best experience. The incidence and severity was highest in patients receiving Herceptin with anthracycline-containing chemotherapy regimens. The clinical trials on this list are studying Margetuximab. Clinical Trials Using Margetuximab. Zai Lab is also working on the gastric cancer clinical trial of Margetuximab. Patients in the margetuximab arm experienced a 24% risk reduction in PFS compared to. Some clinical trials compare existing treatments to determine which is better. Why this matters. On behalf of the more than 5 million Americans living with Alzheimer's and their family members, the Alzheimer's Association is encouraged to learn that Biogen will pursue regulatory approval from the FDA for the investigational drug aducanumab based on Phase 3 clinical trial results from the EMERGE and ENGAGE studies, and other related data. "Continuing our focus on execution, in the second half of the year, we are planning to submit the BLA for margetuximab, initiate two registration-directed Phase 2/3 clinical trials, and provide. 30 September 2019 MacroGenics Presents Margetuximab Data in Gastroesophageal Cancer at the ESMO 2019 Congress. Maryland-based MacroGenics’ metastatic HER2-positive breast cancer treatment margetuximab continues to show promise following a second pre-planned interim overall survival analysis of its Phase III SOPHIA trial. Call the Mercy Medical Research Institute at (417)841-0250 or toll-free 1-866-207-0167 (for those outside the 417 area code) if you are interested in participating in a clinical trial. Department Navigation. Based on the results from a phase III SOPHIA clinical trial, the HER2-targeted antibody, margetuximab, was superior to trastuzumab (Herceptin) in improving progression-free survival (PFS) in patients with pretreated HER2-positive metastatic breast cancer. Its pipeline of immuno-oncology product candidates includes Margetuximab, a monoclonal antibody, which is in Phase III clinical trial that targets HER2-expressing tumors, such as various breast. Combination Margetuximab, INCMGA00012, MGD013, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer (MAHOGANY) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. 30 September 2019 MacroGenics Presents Margetuximab Data in Gastroesophageal Cancer at the ESMO 2019 Congress. The SOPHIA study is a randomized, open-label Phase III clinical trial evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment. ROCKVILLE, MD, USA I January 18, 2018 I MacroGenics, Inc. Margetuximab is a chimeric IgG monoclonal antibody against HER2 designed for the treatment of cancer. Clinical trials. The SOPHIA clinical trial met the primary endpoint of prolongation of progression-free survival (PFS) in patients treated with the combination of margetuximab plus chemotherapy compared to. DB15044: Tafasitamab. The SOPHIA study (NCT02492711) is a randomized, open-label Phase 3 clinical trial evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer. Remarkably, there are ~120 antibody immune checkpoint modulators currently in clinical studies, together comprising ~20% of the total commercial clinical pipeline of antibody therapeutics. Its main driver of growth, margetuximab, remains intact, though, and the Maryland-based company is due to report data from its phase III Sophia trial in second-line or later HER2-positive metastatic breast cancer, in which margetuximab is pitted in combination with chemotherapy against Herceptin and chemotherapy in 530 patients. Those with a low integrated risk of < 5% include the RS 0-10 group irrespective of clinical risk, and 11-25 and low clinical risk –tamoxifen without chemotherapy is an appropriate choice here. EV-201 is a pivotal Phase II trial studying enfortumab vedotin for patients with locally advanced or. MacroGenics said its clinical asset margetuximab met the primary endpoints of prolongation of progression-free survival (PFS) in patients who have HER2-positive metastatic breast cancer. The international trial was conducted in 19 countries across Europe, Asia, North America and South America. Astellas and Seattle Genetics anticipate top-line results from the ongoing Phase II EV-201 study for the first cohort in the first quarter of 2019. To learn more about our clinical trials, contact RCCA at 201-669-4706. If margetuximab is approved, based on SOPHIA data, I believe that this agent could become a valuable treatment option for these patients," said Hope S. It was given orphan drug status for multiple myeloma by the FDA in December 2016. Recently, a press release reported that the phase III trial, comparing the addition to chemotherapy of margetuximab vs trastuzumab in HER2+ mBC patients with progression on prior HER2-targeted treatment, demonstrated a 24%. NMCC Clinical Trials: Recruiting The listing below of clinical trials in use by New Mexico Cancer Center is primarily intended for medical and radiation oncologists, nurses and clinical trial coordinators. MacroGenics, Inc. Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for HER2-positive breast cancer. In patients with breast cancer with human epidermal growth factor receptor 2 (HER2)-positive advanced solid tumors, margetuximab is well tolerated and reduces tumors in more than half of patients who responded to the monoclonal antibody. I think final OS results will be equally influential for Lynparza in pancreatic cancer based on the POLO results. 6 million article requests, users visit JCO. Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer (SOPHIA) Your Message Will Go To Annabel Castaneda 650-728-7977. @EPVantage. A combination of MacroGenics' HER2 antibody margetuximab and standard chemotherapy is superior to Herceptin (trastuzumab) plus chemotherapy at extending the time to disease progression among advanced and pre-treated breast cancer patients whose tumors are positive for HER2 (human epidermal growth factor receptor 2), a Phase 3 trial shows. If you're willing to participate in a clinical trial, you may be able to be treated with margetuximab. The anti-HER2 antibody improved progression-free survival by more. Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). SITC 2019 is the leading destination for scientific exchange, education and networking in the cancer immunotherapy field. The clinical trials on this list are studying Margetuximab. A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment. skip to content Rare Cancer News & Clinical Trials » Google - Merkel Cell Cancer » October 25, 2019. Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer Brief description of study The purpose of this study is to determine whether patients treated with margetuximab plus chemotherapy have longer progression free survival and overall survival than patients treated with trastuzumab. Margetuximab, an investigational monoclonal antibody, improved progression-free survival (PFS) when used in combination with chemotherapy in patients with human epidermal growth factor receptor 2- (HER2) positive metastatic breast cancer, according to new data from a pivotal phase 3 trial. Its main driver of growth, margetuximab, remains intact, though, and the Maryland-based company is due to report data from its phase III Sophia trial in second-line or later HER2-positive metastatic breast cancer, in which margetuximab is pitted in combination with chemotherapy against Herceptin and chemotherapy in 530 patients. An evaluation of efficacy, as measured by progression-free survival (PFS) assessed by independent review and overall survival (OS), of margetuximab plus chemotherapy compared with trastuzumab plus chemotherapy in patients with advanced HER2+ breast cancer who have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting, or in case of having received (neo. Margetuximab increases binding to activating FcyRIIIA (CD16A) and decreases binding to inhibitory FcyIIB (CD32B); antigen binding is the same with margetuximab as with trastuzumab. The Fly team scours all sources of company news, from mainstream to cutting edge,then filters out the noise to deliver shortform stories consisting of only market moving content. ROCKVILLE, MD, January 17, 2019 (GLOBE NEWSWIRE) — MacroGenics, Inc. 6% (15/28), and a clinical benefit rate of 75. Description. MAHOGANY (NCT04082364) is a Phase 2/3 clinical trial in two modules designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). HAGENS BERMAN, NATIONAL TRIAL ATTORNEYS, Reminds MacroGenics (MGNX) Investors of Securities Class Action: Encourages Investors Who Have Suffered Losses to Contact Firm / EIN News / -- Class-action law firm urges MGNX investors who have suffered losses of $50K+ to submit your loss now to learn if they qualify to recover their investment losses. The SOPHIA study is a randomized, open-label Phase III clinical trial evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer. , a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, announced completion of a pre-planned interim futility analysis of the Phase 3 SOPHIA trial. The clinical trials on this list are for gastric (stomach) cancer treatment. 2% DIARREA G3 30. The PALLAS Trial (NCT02513394) is exploring whether palbociclib, a targeted medication taken with adjuvant endocrine therapy, will decrease the chance of breast cancer coming back beyond endocrine therapy alone. The SOPHIA study (NCT02492711) is a randomized, open-label Phase 3 clinical trial evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer. MAbs in the clinical pipeline target CTLA-4, PD-1 and PD-L1, but also other immune system checkpoints such as CD40, GITR, LAG-3, OX40, TIGIT and TIM-3. The SOPHIA study is a study that was conducted by MacroGenics. MAHOGANY is a Phase 2/3 clinical trial in two modules designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line. MacroGenics Announces Margetuximab (MGAH22) Phase 1 Data Presentation at ASCO; Initiates Phase 2 Clinical Study to Evaluate Activity of Margetuximab in Patients with Metastatic Breast Cancer. The company has been testing tucatinib as. See clinical trials of the intervention/treatment in this. The median progression-free survival was 5. Enroll in a breast cancer clinical trial at RCCA today, and receive the best care with the most cutting-edge treatments. See clinical trials of the intervention/treatment in this expanded access record. Margetuximab is an investigational immune-enhancing monoclonal antibody derived from the Company's proprietary Fc Optimization technology platform. Mount Sinai Medical Center ⁄ Mount Sinai News ⁄ Clinical trials XML ⁄ Breast 7 Aug , 2017 PHASE III RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL EVALUATING THE USE OF ADJUVANT ENDOCRINE THERAPY +/- ONE YEAR OF EVEROLIMUS IN PATIENTS WITH HIGH-RISK, HORMONE RECEPTOR-POSITIVE AND HER2/NEU NEGATIVE BRFEAST CANCER. A phase 3 trial of MacroGenics’ margetuximab in HER2-positive metastatic breast cancer patients has met its primary endpoint. Results were sufficiently promising to justify progression to phase 2 trial. Catenacci is an active basic and clinical researcher, focusing on the treatment of gastroesophageal (esophagus, gastroesophageal junction, and stomach. MacroGenics, Inc. What is a Clinical Trial? A clinical trial is a research study designed to answer one or more questions about how a certain drug, treatment or medical device affects a disease. All trials on the list are supported by NCI. Appointments and Referrals Find a Doctor Clinical Trials. For more information on clinical trials, including a search tool specifically for metastatic breast cancer trials, visit the Breastcancer. ROCKVILLE, MD, Sept. MacroGenics will kick off a trial later this year that will pit its Incyte-partnered anti-PD-1 drug against Merck's Keytruda in head and neck cancer. While there are conflicting reports as to whether different FcγR polymorphisms impact clinical response to Herceptin, it is interesting that a phase 3 clinical trial of a next-generation version of Herceptin (margetuximab) with a modified Fc terminus designed to improve recruitment of macrophages and natural killer cells has recently shown. Margetuximab, also known as MGAH22, is a monoclonal antibody that targets HER2-expressing tumors, including breast, gastroesophageal, bladder, and other cancers. Recent Findings. The SOPHIA Study. Rugo, MD, director, Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, discusses the phase III SOPHIA. In all, UTSW researchers are listed as authors or speakers for about four dozen abstracts or other presentations. Appointments and Referrals Find a Doctor Clinical Trials. BOTHELL, Washington, May 10, 2018 /PRNewswire/ -- AGC Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, announced today that in late 2017 it entered into a commercial supply agreement with MacroGenics, a clinical-stage biopharmaceutical company focused on. What is the PALLAS Trial? PALLAS is an abbreviation for PALbociclib CoLlaborative Adjuvant Study. To achieve higher drug efficacy, another HER2-specific antibody, margetuximab, was Fc-engineered to better bind both the low- and high-affinity alleles of CD16A. Oncology clinical trial detail - Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer. The agreement is between MacroGenics and Merck, through a subsidiary. A Phase 3, randomized, multi-center clinical trial (SOPHIA; [NCT02492711][2]) is enrolling patients with metastatic breast cancer, comparing margetuximab plus chemotherapy to trastuzumab plus chemotherapy in patients who have received 1 to 3 lines of therapy for advanced disease. org Clinical Trials pages. Metastatic ERBB2-Positive Breast CancerThe NEfERT-T Randomized Clinical Trial NERATINIB panHER TKI irreversibile Awada, Jama onc, 2016 mPFS 12. All trials on the list are supported by NCI. A clinical trial for this drug is recruiting patients in Oshawa, Ontario and Moncton, New Brunswick. Gastroenterology clinical trial detail - Combination Margetuximab and Pembrolizumab for Advanced, Metastatic HER2(+) Gastric or Gastroesophageal Junction Cancer. The trial was in a combination of pembrolizumab and was targeting patients suffering from advanced HER2+ gastric carcinoma. Human epidermal growth factor receptor 2 positive (HER2+) metastatic breast cancer (MBC) remains an incurable disease, and approximately 25% of patients with HER2+ early breast cancer still relapse after adjuvant trastuzumab-based treatment. MAHOGANY is a Phase 2/3 clinical trial in two modules designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line. A Phase 3, randomized study of margetuximab plus chemotherapy vs. Margetuximab works by blocking the ability of HER2-positive cancer cells to receive chemical signals that tell them to grow. Biopharmaceutical firm MacroGenics has initiated a Phase II/III clinical trial of margetuximab as a first-line therapy for HER2-positive gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. 8 months in the margetuximab arm versus 4. Combination Margetuximab, INCMGA00012, MGD013, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer (MAHOGANY) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The EU Clinical Trials Register currently displays 35896 clinical trials with a EudraCT protocol, of which 5892 are clinical trials conducted with subjects less than 18 years old. ROCKVILLE, MD, January 17, 2019 (GLOBE NEWSWIRE) — MacroGenics, Inc. If you're willing to participate in a clinical trial, you may be able to be treated with margetuximab. or more broadly. 30, 2019 (GLOBE NEWSWIRE) -- MacroGenics, Inc. The trial was in a combination of pembrolizumab and was targeting patients suffering from advanced HER2+ gastric carcinoma. Metastatic ERBB2-Positive Breast CancerThe NEfERT-T Randomized Clinical Trial NERATINIB panHER TKI irreversibile Awada, Jama onc, 2016 mPFS 12. MAHOGANY is a Phase 2/3 clinical trial in two modules designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with advanced or metastatic HER2-positive GEJ/GC. Real-world evidence regarding the efficacy and toxicity of neoadjuvant trastuzumab and pertuzumab in the management of HER2-positive early. We are also evaluating Margetuximab in our Phase 2 clinical trial in patients with HER-2 positive gastric or gastroesophageal junction cancer in combination with an anti-PD-1 mAb. MAbs in the clinical pipeline target CTLA-4, PD-1 and PD-L1, but also other immune system checkpoints such as CD40, GITR, LAG-3, OX40, TIGIT and TIM-3. Margetuximab binds to HER2 with high affinity and produces direct growth suppression of HER2-expressing tumor cell lines. 1 The outlook for metastatic disease remains bleak, with median overall survival (OS) generally not reaching more than 1 year in the majority of clinical trials. In addition to being studied in metastatic breast cancer, margetuximab is also being studied in combination with an anti-PD-1 agent in a Phase 2 clinical trial in gastric cancer, for which data was recently presented at the 2018 European Society of Medical Oncology (ESMO) Congress. The EU Clinical Trials Register currently displays 35982 clinical trials with a EudraCT protocol, of which 5905 are clinical trials conducted with subjects less than 18 years old. 4 mg/m2 Day 1 and 8 of a 21-day cycle or Gemcitabine 1000 mg/m2 Day 1 and 8 of a 21-day cycle or Vinorelbine 25-30 mg/m2 Day 1 and 8 of a 21-day cycle Biological: Margetuximab. MAHOGANY is a Phase 2/3 clinical trial in two modules designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line. NCI's basic information about clinical trials explains the types and phases of trials and how they are carried out. To achieve higher drug efficacy, another HER2-specific antibody, margetuximab, was Fc-engineered to better bind both the low- and high-affinity alleles of CD16A. which is already in phase 3 of development and is very likely to be approved by the FDA given its latest clinical trial's results. Margetuximab demonstrates increased affinity to the activating CD16A Fc-receptor found on NK cells and macrophages and decreased affinity to the inhibitory CD32B receptor compared to trastuzumab. On February 6, 2019 MacroGenics, Inc. One year of treatment is generally accepted based on current clinical trial evidence that demonstrated the superiority of one-year treatment over none. MAHOGANY (NCT04082364) is a Phase 2/3 clinical trial in two modules designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first. Sequence of anthracyclines and taxanes in the neoadjuvant chemotherapy of HER2-negative breast cancer: Experience of a Brazilian oncological center. 2017;28(4):855-861. In CD16A-158F carriers, the PFS was. A clinical trial for this drug is recruiting patients in Oshawa, Ontario and Moncton, New Brunswick. Trastuzumab Plus Chemotherapy in the Treatment of Patients with HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment. Keywords Search. 22 Oct 2019 Efficacy and Adverse events data from the phase III SOPHIA trial in Breast Cancer presented released by MacroGenics ; 30 Sep 2019 Efficacy data from a phase II in advanced HER2-positive gastroesophageal adenocarcinoma presented at the European Society for Medical Oncology Annual Congress (ESMO-2019). Why this matters. Phase III POLO trial Patienter med metastatisk PC, samt BRCA1- og/ eller BRCA2-germline mutation, fik min. A critical component of the Phase III SOPHIA trial was measuring the Case 8:19-cv-02713-GJH Document 1 Filed 09/13/19 Page 2 of 17. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced presentation of updated data from its Phase 2 clinical trial of margetuximab plus. The SOPHIA study (NCT02492711) is a randomized, open-label Phase 3 clinical trial evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer. (NASDAQ:MGNX) has presented updated data from its Phase 2 clinical trial of margetuximab. Some clinical trials compare existing treatments to determine which is better. 2% DIARREA G3 30. Use the tool below to find a CTCA ® clinical trial for your cancer type. These studies follow a strict protocol â€" a written plan of actions. Remarkably, there are ~120 antibody immune checkpoint modulators currently in clinical studies, together comprising ~20% of the total commercial clinical pipeline of antibody therapeutics. Phase 2 Study of the Monoclonal Antibody MGAH22 (Margetuximab) in Patients With Relapsed or Refractory Advanced Breast Cancer. Phase 2 Study of the Monoclonal Antibody MGAH22 (Margetuximab) in Patients With Relapsed or Refractory Advanced Breast Cancer The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Cookie Notice. Clinical trials are a key testing ground for determining the effectiveness and safety of new treatments and drugs for cancer and other diseases. It was given orphan drug status for multiple myeloma by the FDA in December 2016. Margetuximab also was designed to improve the ability of immune cells to bind to HER2-positive breast cancer cells, allowing the immune cells to destroy the cancer cells. Official Title: An Expanded Access (Compassionate Use) Program Providing Margetuximab in the Treatment of HER2+ Metastatic Breast Cancer and Other HER2+ Carcinomas in Single, Individually-approved Patients. MacroGenics Inc. Novartis (NYSE: NVS) announced the FDA placed a partial hold on clinical trials for intrathecal administration of Zolgensma (AVXS-101) following findings from a pre-clinical trial in which animal findings showed dorsal root ganglia (DRG) mononuclear cell inflammation, sometimes accompanied by neuronal cell body degeneration or loss. Cancer trials may offer patients access to treatment options that would otherwise be unavailable to them. The SOPHIA study (NCT02492711) is a randomized, open-label Phase 3 clinical trial evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer. The SOPHIA study (NCT02492711) is a randomized, open-label Phase 3 clinical trial evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive. One disadvantage of multiarm study design is that the effective experimental treatments are discovering almost 15 months later compared with separate two-arm trial. This clinical trial is being sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases. MacroGenics said its clinical asset margetuximab met the primary endpoints of prolongation of progression-free survival (PFS) in patients who have HER2-positive metastatic breast cancer. For questions, or to speak with someone directly, please call: 1-888-824-0200. MacroGenics Announces Date of Third Quarter 2019 Financial Results Conference Call Read More. The trial. MacroGenics, Inc. Margetuximab binds to HER2 with high affinity and produces direct growth suppression of HER2-expressing tumor cell lines. (Also, don’t miss several UTSW meeting highlights. To refer a patient for this clinical trial contact the Karmanos Patient Concierge at 800-527-6266, email [email protected]