Complementary & Alternative Medicine (CAM) Questions to Ask about Your Treatment. Of particular note, incidence of blurred vision was reduced from 55%, mostly . Maintenance therapy (e.g., bevacizumab, PARP inhibitors) will be considered as part of the preceding line of therapy (i.e., not counted independently); Therapy changed due to toxicity in the absence of progression will be considered as part of the same line (i.e., not counted independently); Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance. Purpose This phase I expansion cohort study evaluated the safety and clinical activity of mirvetuximab soravtansine (IMGN853), an antibody-drug conjugate consisting of a humanized anti-folate receptor alpha (FRα) monoclonal antibody linked to the tubulin-disrupting maytansinoid DM4, in a population of patients with FRα-positive and platinum-resistant ovarian cancer. Found insideIn this book, leading experts in cancer immunotherapy join forces to provide a comprehensive guide that sets out the main principles of oncoimmunology and examines the latest advances and their implications for clinical practice, focusing ... A novel, reversible ocular side effect of the biologic mirvetuximab soravtansine changing the corneal topography was identified. Most adverse events during the trial were mild. (A) Percentage of tumor change in target lesions from baseline in patients withâ¦, Kaplan-Meier analysis of progression-free survivalâ¦, Kaplan-Meier analysis of progression-free survival (PFS) in (A) all patients (median, 4.8 months)â¦, MeSH Describes the nature of a clinical study. Furthest along in development is mirvetuximab soravtansine, recently studied in a phase 3 clinical trial in previously treated folate receptor alpha-positive, platinum-resistant ovarian cancer, and also being tested in additional situations and tumor types, Moore said. Patients must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity. Covering a comprehensive range of common, rare, benign and malignant lesions, Pathology of the Female Reproductive Tract, 3rd Edition, authored by an international panel of subspecialty experts, brings you the latest scientific and ... Mirvetuximab soravtansine is an antibody-drug conjugate. Found insideWith topics like high content screening, scoring, docking, binding free energy calculations, polypharmacology, QSAR, chemical collections and databases, and much more, this book is the go-to reference for all academic and pharmaceutical ... Mirvetuximab soravtansine (IMGN853) is an antibody -drug conjugate (ADC) comprising a folate receptor alpha (FR α)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin- targeting agent. Types include: During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. Fatigue and neutropenia were also seen at a high frequency (56%), with the latter event accounting for the . Patient’s tumor must be positive for FRα expression as defined by the Ventana FOLR1 (FOLR-2.1) CDx assay. Found inside – Page 36... tumor tissues and improve therapeutic effect but also reduce side effects. ... mirvetuximab soravtansine for ovarian cancer, rovalpituzumab tesirine for ... This phase I trial studies the side effects and best dose of mirvetuximab soravtansine and gemcitabine hydrochloride in treating patients with folate receptor (FR) alpha-positive ovarian, primary peritoneal, fallopian tube, endometrial, or triple negative breast cancer that has come back. Mirvetuximab soravtansine. The adverse events (AEs) observed with the doublet were as expected based on the side effect profiles of each agent. This book will be an invaluable source of information for both practicing clinical oncologists and oncologists in training. Intraperitoneal chemotherapy is increasingly being used as first-line treatment for ovarian cancer. Antibody-drug conjugates for ovarian cancer: current clinical development. This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in patients with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate Receptor-Alpha (FRα). 2021 Jul 26;10(3):30. doi: 10.3390/antib10030030. Drug class side effects Moore KN, Martin LP, O'Malley DM, Matulonis UA, Konner JA, Vergote I, Ponte JF, Birrer MJ. Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin . Furthest along in development is mirvetuximab soravtansine, recently studied in a phase 3 clinical trial in previously treated folate receptor alpha-positive, platinum-resistant ovarian cancer, and also being tested in additional situations and tumor types, Moore said. Adjusting to Cancer. Observational study — observes people and measures outcomes without affecting results. ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced mature data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin ® (bevacizumab) in patients with medium and high folate receptor alpha (FRα)-expressing recurrent ovarian cancer for whom a non-platinum based . 1728 Clin Cancer Res; 25(6) March 15, 2019 Clinical Cancer Research Mirvetuximab soravtansine is an antibody-drug conjugate, a type of agent attaches a chemotherapy drug to a molecule that binds to a protein on the outside of cancer cells. Patients with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade or borderline ovarian tumor. The purpose of this study is to compare the effectiveness and safety of mirvetuximab soravtansine vs. investigator's choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Its side effects include manageable diarrhea, fatigue and blurred vision. Found insideThis authoritative volume provides a holistic picture of antibody-drug conjugates (ADCs). Gynecol Oncol. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. Immune Rebalancing: The Future of Immunosuppression summarizes the most promising perspectives of immunopharmacology, in particular in the area of immunosuppression by considering molecular pathways, personalized medicine, microbiome and ... WCBP must have a negative pregnancy test within 4 days prior to the first dose of study drug. Patients with a previous clinical diagnosis of non-infectious interstitial lung disease (ILD), including noninfectious pneumonitis. Immunotherapy in endometrial cancer: rationale, practice and perspectives. d. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) e. AST and ALT ≤ 3.0 x ULN. Note: Testing at screening is not required for the above infections unless clinically indicated. Adverse events were generally mild (⤠grade 2), with diarrhea (44%), blurred vision (41%), nausea (37%), and fatigue (30%) being the most commonly observed treatment-related toxicities. A single copy of these materials may be reprinted for noncommercial personal use only. Three patients are not represented in the plots: two with clinical progression and another who died before undergoing baseline assessment. Mirvetuximab Soravtansine has been used in trials studying the treatment of Ovarian cancer, Endometrial Cancer, Fallopian tube cancer, Epithelial Ovarian Cancer, and Primary Peritoneal Cancer, among others. Mirvetuximab soravtansine (IMGN853) is an antibody -drug conjugate (ADC) comprising a folate receptor alpha (FR α)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin- targeting agent. Drugs such as mirvetuximab soravtansine are antibodies linked to a toxic substance and may help find certain tumor cells and kill them without harming normal cells. Mirvetuximab soravtansine is an antibody drug conjugate, comprising of a FRα-binding antibody linked to the tubulin-disrupting maytansinoid DM4, being developed NCT04296890. Found inside – Page iThe purpose of this book is to describe the variety of payloads used to date, along with a discussion of their advantages and disadvantages and to provide information on novel payloads at the research stage that may be used clinically in ... Major surgery must be completed at least 4 weeks prior to first dose and have recovered or stabilized from the side effects of prior surgery. Grade 3 fatigue and hypotension were reported in two patients each (4%). Ocular side effects are manageable and reversible, said Lim, with Murphy adding keratopathy is manageable with eye drops. Patients must have platinum-resistant disease: Patients who have only had 1 line of platinum based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between > 3 months and ≤ 6 months after the date last dose of platinum; Patients who have received 2 or 3 lines of platinum therapy must have progressed on or within 6 months after the date of the last dose of platinum. Bethesda, MD 20894, Copyright Patients must have progressed radiographically on or after their most recent line of therapy. However, those therapies have side effects and with microtubule toxins, taxanes, docetaxel, Abraxane, and paclitaxel, which are used again and again, a patient experiences cumulative neuropathy,. 2020 May;157(2):379-385. doi: 10.1016/j.ygyno.2020.01.037. Piribedil is also used to associated treatment for these conditions: Parkinson's Disease (PD) patients receiving mirvetuximab soravtansine is summarized. Mirvetuximab soravtansine (IMGN853) is an antibody-drug conjugate (ADC) comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin . Kaplan-Meier analysis of progression-free survival (PFS) in (A) all patients (median, 4.8 months) and (B) cohorts of patients who had received one to three and four or more prior lines of therapy (median, 6.7 and 3.9 months, respectively; log-rank. Side Effects of Cancer Treatment. Mirvetuximab soravtansine is a monoclonal antibody targeting FRα that is conjugated to the cytotoxic drug maytansinoid DM4, which directly induces mitotic arrest in FRα + tumors. Cancer. Unable to load your collection due to an error, Unable to load your delegates due to an error. Absolute neutrophil count (ANC) =1.5 x 10^9/L (1,500/µL) without Epub 2017 Nov 3. Mirvetuximab soravtansine comprises an anti-folate receptor alpha (FRα) antibody conjugating to DM4 through a cleavable disulfide linker 101. Women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) in while on study drug and for at least 3 months after the last dose of MIRV or at least 6 months after the last dose of Pac, PLD, or Topo. Privacy, Help This phase I trial studies the side effects and best dose of mirvetuximab soravtansine and rucaparib camsylate in treating participants with endometrial, ovarian, fallopian tube or primary peritoneal cancer that has come back. Safety and activity findings from a phase 1b escalation study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with carboplatin in patients with platinum-sensitive ovarian cancer. The most common ADC-related adverse events included nausea, blurred vision and keratopathy, with Grade 3 or greater only constituting 1-2% of events. Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Feelings and Cancer. Found inside... mg/m2 with the usual physical side effects of nausea, diarrhea, and fatigue. ... Soravtansine has been conjugated to mirvetuximab, which targets folate ... ABOUT MIRVETUXIMAB SORAVTANSINE Mirvetuximab soravtansine (IMGN853) is an antibody-drug conjugate (ADC) comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the . Please contact the study team for the most up-to-date information regarding possible participation. Mirvetuximab soravtansine in combination with Avastin in patients with FRα-positive platinum-resistant ovarian cancer continues to demonstrate anti-tumor activity with durable responses and a . The protein targeted by mirvetuximab soravtansine is called folate receptor-alpha (FRalpha). Targeting cancer with antibody-drug conjugates: Promises and challenges. In lymphomas we've been talking about brentuximab vedotin, another antibody-drug conjugate. They also compare the safety of the new treatment with that of current treatments. Study statuses change often. Contact the study team to discuss study eligibility and potential participation. Notably, in the subset of patients who had received three or fewer prior lines of therapy (n = 23), an objective response rate of 39%, PFS of 6.7 months, and duration of response of 19.6 weeks were observed. Phase Ib study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients with platinum-resistant ovarian cancer. Moore KN, Borghaei H, O'Malley DM, Jeong W, Seward SM, Bauer TM, Perez RP, Matulonis UA, Running KL, Zhang X, Ponte JF, Ruiz-Soto R, Birrer MJ. Cao W, Ma X, Fischer JV, Sun C, Kong B, Zhang Q. Biomark Res. Moore KN, O'Malley DM, Vergote I, Martin LP, Gonzalez-Martin A, Malek K, Birrer MJ. The purpose of this study is to compare the effectiveness and safety of mirvetuximab soravtansine vs. investigator's choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients must have adequate hematologic, liver, and kidney functions defined as: Absolute neutrophil count (ANC) ≥ 1.5 x 10^9 /L (1,500/μL) without G-CSF in the prior 10 days or long-acting WBC growth factors in the prior 20 days; Platelet count ≥ 100 x 10^9 /L (100,000/μL) without platelet transfusion in the prior 10 days; Hemoglobin ≥ 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 21 days; Serum creatinine ≤ 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN f. Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 x ULN); Patients or their legally authorized representative must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements. Patients with clinically significant cardiac disease including, but not limited to, any one of the following: Myocardial infarction ≤ 6 months prior to first dose; Uncontrolled congestive heart failure (New York Heart Association > class II); Uncontrolled ≥ Grade 3 hypertension (per CTCAE); Left ventricular ejection fraction (LVEF) below the institutional limit of normal as measured by echocardiography (ECHO) or multigated acquisition (MUGA) scan. adverse side-effects, but they appear to be mostly manageable, and the drugs appear to be relatively safe compared to the symptoms of the advanced cancer. This receptor can be expressed in varying degrees, and thus after the failure of FORWARD I, Immunogen has two trials designed to bring mirvetuximab soravtansine to patients with high expression of FR-A , platinum-resistance ovarian cancer. 2018 Oct;151(1):46-52. doi: 10.1016/j.ygyno.2018.07.017. "Although there have been advances in the treatment of platinum-sensitive . Bookshelf Adverse events were generally mild (≤ grade 2), with diarrhea (44%), blurred vision (41%), nausea (37%), and fatigue (30%) being the most commonly observed treatment-related toxicities. Found insideProvides unique insider insight into the current drug development process, and what it takes to achieve success In this fourth volume in the series, inventors and primary developers of drugs that made it to the market continue telling the ... PMC Note: does not include tumors with a negligible risk for metastasis or death (e.g., adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast). Mirvetuximab soravtansine contains a monoclonal antibody (mAb) that enables it to bind to FRα-positive tumor cells with ImmunoGen's DM4, a maytansinoid cancer-killing agent, attached to kill these cells. Future Oncol. MAbs. This site needs JavaScript to work properly. Progress in Gynecologic Cancers with Antibody Drug Conjugates. Found insideThis book focuses on the context dependency of cell signaling by showing how the endosomal system helps to structure and regulate signaling pathways. Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best. Prevention and treatment information (HHS). There are also less common very early (phase 0) and later (phase 4) phases. Mirvetuximab soravtansine is a folate-receptor alpha (FRα)-targeting ADC in late-stage clinical development showing promise for the treatment of recurrent ovarian cancer. The most common adverse reactions were diarrhea (52%), blurred vision (50%), nausea (45%), and fatigue (41%), the majority of which were mild-to-moderate (≤grade 2) and readily managed with supportive care. Found inside – Page 247trials of mirvetuximab soravtansine involved 44 patients with FR ovarian, cervical, ... that can be tolerated without any major adverse effects to the body. On the basis of these findings, the dose, schedule, and target population were identified for a phase III trial of IMGN853 monotherapy in patients with platinum-resistant disease. The addition of mirvetuximab soravtansine to bevacizumab (Avastin) induced promising objective response rates (ORRs) in patients with platinum-agnostic ovarian cancer regardless of the platinum status, according to interim findings of a study presented during the American Society of Clinical Oncology Virtual Scientific Program. Gynecol Oncol. Beverly A. Teicher and a panel of leading experts comprehensively describe the state-of-the-art in animal tumor model research. This volume updates and extends the comprehensive presentations in the first edition. A to Z List of Cancer Drugs. The report is based on Addenda 3–9 to Publication 53. Addenda 3–7 have been available on the ICRP website (www.icrp.org) as interim reports. The work has been carried out by a Joint Task Group of ICRP Committees 2 and 3. Mirvetuximab soravtansine (ImmunoGen Inc., Waltham, MA, USA) is an anti-FRα ADC conjugated with the tubulin-targeting DM4 through a cleavable linker, with promising activity in epithelial ovarian carcinoma. Mirvetuximab soravtansine (IMGN853) is an anti-FRα antibody-drug conjugate (ADC), consisting of an FRα-binding antibody attached to a highly potent maytansinoid, which induces cell-cycle arrest . Found insideThe book discusses several topics related to pancreatic cancer, such as stem cells, drug resistance and pancreatic tumor microenvironment, the latest developments in chemotherapy for metastatic cancer and chemoprevention, and epigenome as a ... Theseresultsmayhavebroad implicationsfortheapplication of this and other ADCs for which ocular side effects are an important clinical consideration. Found insideThis book elaborates on drug delivery targeting via intracellular delivery, specifically through the Receptor Mediated Endocytosis (RME) approach, due to the involvement of cellular receptors in various grave diseases. Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin . Patients must have at least one lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator). Cancer Center Clinical Trials Referral Office. It is easy to take, it's convenient, it has minimal side effects, and it is efficacious. For all evaluable patients, the confirmed objective response rate was 26%, including one complete and 11 partial responses, and the median PFS was 4.8 months. Found inside – Page 233The following example combines the ADC mirvetuximab soravtansine with either ... on the one side, is released in a controlled way in the tumor's proximity, ... Upper Tract Urothelial Carcinoma represents the first book of its kind to be dedicated solely to UTUC. The median duration of response was 19.1 weeks. Inebilizumab: The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Inebilizumab. Disclaimer, National Library of Medicine Simultaneous participation in another research study, in countries or localities where this is the health authority guidance. In preclinical research conducted by ImmunoGen and independent scientists, antibody-drug conjugates with maytansinoids have been found to . Mirvetuximab attaches to FOLR1 positive cancer cells in a targeted way and delivers DM4 to kill them. 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