Mirvetuximab soravtansine trial. Here is how you know .

Mirvetuximab soravtansine trial PubMed 26. S. Mirvetuximab soravtansine (IMGN853) is an antibody-drug conjugate that selectively targets folate receptor α (FRα). Ann Oncol. Patients with advanced, FRα-positive TNBC were enrolled on PURPOSESingle-agent chemotherapies have limited activity and considerable toxicity in patients with platinum-resistant epithelial ovarian cancer (PROC). Mirvetuximab soravtansine demonstrated remarkable efficacy, with statistically significant outcomes in key measures. The primary Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis o Nota Bene Cancer 481 - Mené sur 366 patientes atteintes d'un cancer épithélial de l'ovaire rési Mirvetuximab soravtansine (mirvetuximab soravtansine-gynx; ity of response in the phase III SORAYA trial (Sect. Konecny GE, Moore KN, Lebreton C, et al. Safety and efficacy results in patients who received dose modifications in the phase 3 MIRASOL (GOG 3045/ENGOT-ov55) trial of mirvetuximab soravtansine vs investigator’s choice chemotherapy (ICC) in platinum-resistant ovarian cancer (PROC) with high folate receptor-alpha expression. SORAYA is a single-arm, phase II study evaluating efficacy and safety of MIRV in patients with PROC. The phase III FORWARD I trial fell short of its primary endpoint, as findings showed the antibody-drug conjugate mirvetuximab soravtansine did not result in a progression-free survival (PFS) improvement compared with&nbsp;chemotherapy&nbsp;in patients with folate receptor alpha (FR&alpha;) positive, A randomized, multicenter phase III trial (FORWARD I) compared mirvetuximab soravtansine treatment to other chemotherapeutic drugs (topotecan, paclitaxel, pegylated liposomal doxorubicin) in Mirvetuximab soravtansine-gynx has the following uses: approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Full Text (PDF) Scopus (129) PubMed. Median PFS: 5. 15,16 IMGN853 binds with high affinity and specificity to FRα on the surface of tumor cells, which, upon antigen binding, promotes ADC internalization and intracellular MIRASOL is a global Phase 3 open-label, randomized, controlled trial that enrolled 453 patients to compare the efficacy and safety of mirvetuximab soravtansine with the investigator's choice of OS benefit over chemotherapy in a phase 3 trial of PROC (MIRASOL trial; median follow-up period of 13. Mirvetuximab soravtansine (IMGN853) demonstrated meaningful anti-tumor activity with consistent safety and favorable tolerability in patients with folate receptor alpha (FRα)–high platinum-resistant ovarian cancer who have been previously treated with bevacizumab (Avastin), meeting the primary end point of the SORAYA trial (NCT04296890), During an interview with CancerNetwork ®, Ritu Salani, MD, discusses how the benefit of mirvetuximab soravtansine-gynx (Elahere) in patients with folate receptor-α–positive, platinum-resistant cancer was further confirmed in the phase 3 MIRASOL trial (NCT04209855). Open a printable version of this page ; Email the URL of this page to Background: Folate receptor-alpha (FRα) is expressed on endometrial cancer (EC) cells and is associated with poor prognosis. Survival outcomes with mirvetuximab soravtansine were also superior to those with physician’s choice of chemotherapy regardless of whether a person A randomized phase II trial of mirvetuximab soravtansine (IMGN853), in folate receptor alpha (FRα)-high recurrent ovarian cancer eligible for platinum-based chemotherapy. Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate targeting folate receptor α (FRα). J Clin Oncol 2022;40:5514. gov ID: NCT04209855 Sponsor: ImmunoGen, Inc. 0046 ‡ ORR: 42% vs 16%, P0. Allocation. Alvarez Secord on X: “New article in press: The Efficacy and Safety of Mirvetuximab Soravtansine in FRα-Positive, Third-Line and Later, Recurrent Platinum-Sensitive Ovarian Cancer: The Single-Arm Phase 2 PICCOLO Trial. The drugs involved in the trial are: Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed. AbbVie announced positive topline results from the Phase II PICCOLO trial evaluating investigational mirvetuximab soravtansine (ELAHERE) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRalpha) Updated Phase III MIRASOL Trial Results: Mirvetuximab Soravtansine vs Chemotherapy in Platinum-Resistant Ovarian Cancer with High Folate Receptor-Alpha Expression . Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Positive results from the confirmatory MIRASOL trial were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, confirming that mirvetuximab soravtansine confers Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I. Accumulating pre-clinical and clinical data supported the safety and anti-tumor activity of MIRV in tumors expressing FRα. Ann Oncol 32 :757-765, 2021 [ PubMed ] [ Google Scholar ] 746P - Phase III MIRASOL trial: Updated overall survival results of mirvetuximab soravtansine (MIRV) vs. As previously reported, the single-arm, phase II SORAYA trial (NCT04296890) of mirvetuximab soravtansine-gynx in FRα-expressing, platinum- resistant ovarian cancer met its primary endpoint We have previously reported dose finding results for the mirvetuximab soravtansine plus bevacizumab doublet as part of the Phase Ib/II FORWARD II trial (NCT02606305) [20]. This review summarizes current evidence of mirvetuximab soravtansine in platinum-resistant Background: Elevated FRα expression is a characteristic of several solid tumors, including epithelial ovarian cancer (EOC), thereby providing an attractive candidate for targeted therapeutic approaches. In this phase 1 dose-escalation study, the authors investigated IMGN853 in patients with FRα-positive solid tumors. Mirvetuxi- mab soravtansine has manageable tolerability, with eye disorders being the most common Official Title. 0 months, P0. Patients are selected for treatment based on an FDA PICCOLO trial met its primary endpoint of objective response rate (ORR) Data from the study will be presented at a future medical meeting; NORTH CHICAGO, IL – AbbVie (NYSE: ABBV) announced positive topline results from the Phase 2 PICCOLO trial evaluating investigational mirvetuximab soravtansine (ELAHERE ®) monotherapy in heavily pre-treated Mirvetuximab soravtansine is an ADC comprising an IgG1 monoclonal antibody against the folate receptor alpha (FRα) conjugated to the cytotoxic maytansinoid effector molecule DM4 that has shown In the conrmatory phase 3 MIRASOL trial, mirvetuximab soravtansine signicantly improved median progression-free survival, objective response rates, and median overall survival compared with investigator’s choice of nonplatinum chemotherapy in patients with this indication. investigator’s choice chemotherapy (ICC) in patients (pts) with platinum-resistant ovarian cancer (PROC) and high folate receptor-alpha (FRα) expression. Purpose: To evaluate the safety and clinical activity of mirvetuximab soravtansine, an antibody-drug conjugate comprising a humanized anti-folate receptor alpha (FRα) monoclonal antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent, in combination with bevacizumab in patients with FRα-positive, platinum-resistant ovarian cancer. Treatment. SORAYA is a global single arm phase 3 study Other presentations from AbbVie's ADC platform include safety and efficacy data in an older population (≥ 65) from the Phase 3 MIRASOL trial of mirvetuximab soravtansine (MIRV) vs investigator's choice chemotherapy in patients with platinum-resistant ovarian cancer (PROC) and high folate receptor-alpha (FRα) expression, and a retrospective Results from the MIRASOL trial were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. DOI: 10. Sequential Assignment. Clinical use of antibody drug conjugates Ovarian cancer. 3); continued approval for this indication is contingent upon the verication of its clinical benet in a conrmatory trial, MIRASOL (NCT04209855), which has reached full patient enrolment [3 , 4]. 50-0. D, Oaknin. called folate receptor alpha (FRα). This phase II trial studies the effect of mirvetuximab soravtansine in treating patients with folate receptor-alpha positive endometrial cancer that remains despite treatment (persistent) or has come back (recurrent). Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Patients with folate receptor-alpha (FRα) positive, platinum-resistant ovarian cancer treated with mirvetuximab soravtansine (Elahere) were shown to have a better health-related quality of life (HRQOL) vs the investigator’s choice of chemotherapy, as demonstrated by patient-reported outcomes (PROs) from the phase 3 MIRASOL trial (NCT04209855). Authors : Fabian Trillsch , Fabienne Schochter , Tjoung-Won Park-Simon , Alexander Reuss , Tanja N. Patients with advanced, FRα-positive TNBC were enrolled on FORWARD I trial, designed to assess the safety and clinical activity of MIRV as compared with investigator’s choice (IC) chemotherapy in patients with FRa-positive, platinum-resistant EOC. Mirvetuximab soravtansine-gynx is available in the following dosage form(s) and strength(s): Injection concentrate: 100 mg/20 mL (5 mg/mL) in a Patients deemed otherwise clinically unfit for clinical trial per investigators discretion. Food and Drug Administration (FDA) fully approved mirvetuximab soravtansine-gynx (Elahere ®) for adult patients with FR alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens. MIRV has demonstrated single-agent Kathleen N. In November 2022, mirvetuximab "The PICCOLO data further support the potential of mirvetuximab soravtansine for platinum-sensitive ovarian cancer patients. Non-Randomized. 3 months showed significant and clinically meaningful improvements in PFS, ORR, and OS with MIRV versus IC chemotherapy in PROC Home; Archive; Volume 34, Issue Suppl 1 ; 360 Health-related quality of life in patients with FRα positive platinum-resistant ovarian cancer treated with mirvetuximab soravtansine vs. Both of these ADCs are associated with ocular adverse events, which are not commonly caused by other treatments for gynecologic cancers. 25, 26 MIRV received full US Food and Drug Administration approval in March 2024 for patients with FRα-positive platinum-resistant EOC (PROC) with 1-3 Don't miss. Search ADS. Please see Full Prescribing Information, including BOXED WARNING and Medication Guide. Video. 5 months vs 12. Clinical trial information: NCT04209855. Ann. ∙ Pignata, S. Following a promising dose-escalation study on single-agent mirvetuximab, a recently published phase Ib trial of mirvetuximab soravtansine (6 mg/kg In the randomized, phase 3 MIRASOL trial, 453 patients with FRα+ PROC received either mirvetuximab soravtansine (n = 227) or investigator's choice single-agent chemotherapy (n = 226). In this ph BACKGROUND Mirvetuximab soravtansine (IMGN853) is an antibody-drug conjugate that selectively targets folate receptor α (FRα). Patients and methods . home / insights / updated-phase-iii-mirasol-trial-results-mirvetuximab-soravtansine-vs-chemotherapy-in-platinum. In 2017, a phase I expan Background: Mirvetuximab soravtansine (IMGN853) is an antibody-drug conjugate that selectively targets folate receptor α (FRα). Moore KN, Oza AM, Colombo N, et al. [now a part of AbbVie]) for adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Learn more about ELAHERE® (mirvetuximab soravtansine-gynx) for injection, a prescription medicine. 3,4 • FRα is expressed in ~90% of ovarian carcinomas, 5, 6. Mirvetuximab soravtansine is an antibody-drug conjugate (ADC) comprising an FRï ¡-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-target- ing agent that has consistently shown clinically The MIRASOL phase III trial compared mirvetuximab soravtansine (n = 227) to standard-of-care chemotherapy (n = 226) in a total of 453 patients with platinum-resistant ovarian cancer and high FRα expression. As part of the AbbVie’s monoclonal antibody Elahere (mirvetuximab soravtansine-gynx) has bagged full approval from the US Food and Drug Administration (FDA) for the treatment of certain types of Findings from the confirmatory, randomized, global, Phase III MIRASOL trial (NCT04209855) supported full approval of MIRV by the US Food and Drug Administration Data from the phase 3 MIRASOL trial support the European marketing authorization application for mirvetuximab soravtansine as a treatment for folate receptor Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent The active substance in Elahere, mirvetuximab soravtansine, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to folate receptors on the surface of The phase Ib FORWARD II trial evaluated the antibody-drug conjugate mirvetuximab soravtansine plus bevacizumab in patients with ovarian cancer who had disease The SORAYA phase 3 trial improved patient selection, which led to accelerated Food and drug administration (FDA) approval of mirvetuximab soravtansine, and evaluated drug PICCOLO is a phase 2, global, open-label, single-arm trial of MIRV as third-line or greater (≥3L) treatment in patients with FRα-positive (≥75% of cells with ≥2+ staining intensity) The FDA granted accelerated approval to mirvetuximab soravtansine in 2022 for patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary A群：mirvetuximab soravtansine +ベバシズマブ B群：ベバシズマブ. Now, data from one of the arms of the phase Ib FORWARD II trial show that the addition of the antibody–drug conjugate mirvetuximab soravtansine to carboplatin and bevacizumab has promising This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine (MIRV) vs. " Mirvetuximab soravtansine is a first-in-class antibody-drug conjugate (ADC) composed of an FRα-binding antibody, cleavable linker, and a tubulin inhibitor. Markham, MD, from the University of Florida in Gainesville, commended the benefits of mirvetuximab soravtansine when compared with chemotherapy. Herein, are the results of the first prospective phase II trial evaluating mirvetuximab-s in metastatic TNBC. I have read the ImmunoGen Protocol IMGN853-0417 and agree to Mirvetuximab soravtansine-gynx (MIRV) is a conjugate of a folate receptor alpha (FRα)-directed antibody and the maytansinoid microtubule inhibitor, DM4. Moore1, Amit M. A randomized phase II study of bevacizumab and weekly anetumab ravtansine or weekly paclitaxel in platinum-resistant or refractory ovarian cancer NCI trial #10150. Study Methods. 2021; 32:757-765. The results of this study will help define the About the PICCOLO trial PICCOLO is a single-arm Phase 2 trial evaluating the efficacy and safety of mirvetuximab soravtansine monotherapy in patients with FR-alpha high platinum-sensitive ovarian cancer who have Background: Mirvetuximab soravtansine-gynx (MIRV) is a first-in-class, folate receptor alpha (FRα)-targeting antibody-drug conjugate with US Food and Drug Administration approval for FRα-positive platinum-resistant ovarian cancer. In this phase 1 dose MIRASOL is a global Phase 3 open-label, randomized, controlled trial that enrolled 453 patients to compare the efficacy and safety of mirvetuximab soravtansine with the investigator’s choice of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan) in the treatment of platinum-resistant, high-grade serous ovarian Nous voudrions effectuer une description ici mais le site que vous consultez ne nous en laisse pas la possibilité. 2024 recommend mirvetuximab soravtansine-gynx (ELAHERE®) SORAYA was a pivotal single-arm trial evaluating the efficacy and safety of ELAHERE in patients with FRα-positive, platinum-resistant ovarian cancer 1,2. Two hundred and eight trial sites across four continents will participate in the study. 1. The active substance in Elahere, mirvetuximab soravtansine, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to folate receptors on the surface of cancer cells. Google Scholar. 4 The Official Title. Pts with PROC, 1-3 prior lines of therapy, and FRα positivity by LBA5507 Background: Mirvetuximab soravtansine (MIRV), an antibody drug conjugate targeting FRα, demonstrated clinically meaningful antitumor activity in a single arm trial reported previously On March 22, 2024, the Food and Drug Administration approved mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc. ) for adult patients with folate receptor alpha (FRα The authorization was based on data from the global phase 3 MIRASOL trial (NCT04209855), in which treatment with mirvetuximab soravtansine led to a 35% reduction in the risk of disease progression The efficacy of maintenance mirvetuximab soravtansine plus bevacizumab is being compared with bevacizumab alone in patients with folate receptor alpha–positive recurrent platinum-sensitive comes. Matulonis , Ana Oaknin , Sandro Pignata , Hannelore denys , Nicoletta Colombo , Toon Van Gorp , Jason A. This integrated safety summary sought to characterize the safety profile of MIRV monotherapy in participants with FRα-expressing recurrent EOC. A. 7 months, P=0. The anti-FR-α monoclonal antibody present in mirvetuximab Mirvetuximab soravtansine (Elahere) improved health-related quality of life (HRQOL) compared with the investigator’s choice of chemotherapy in a patient-reported outcome (PRO) from the phase 3 MIRASOL trial (NCT04209855) for patients with folate receptor-alpha (FRα) positive, platinum-resistant ovarian cancer. FR-alpha helps get folate, a B vitamin, into cells. 0001 † Median OS: 16. treatment of subjects with Mirvetuximab soravtansine (MIRV) uses a mAB that finds and binds to folate receptor-alpha (FR-alpha). Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line The FDA granted accelerated approval to mirvetuximab soravtansine in 2022 for patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who Mirvetuximab soravtansine is an antibody-drug conjugate that consists of a monoclonal antibody against FRα conjugated to maytansinoid, a microtubule inhibitor. Mirvetuximab soravtansine (MIRV) is an ADC comprising a FRα-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent. Mirvetuximab soravtansine improves outcomes over chemotherapy in patients with FRα+ platinum-resistant ovarian cancer, a phase 3 trial suggests. Malte Renz MD, PhD, Oliver Dorigo MD, PhD, in DiSaia and Creasman Clinical Gynecologic Oncology (Tenth Edition), 2023. Participants will be, in the opinion of the Investigator, appropriate for single Background: Mirvetuximab soravtansine is an ADC comprising a FRα-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent. Experimental group. As part of the Phase 1b FORWARD II trial (NCT02606305), the combination of mirvetuximab soravtansine with bevacizumab (BEV) was evaluated in pts with FRα-positive, platinum-resistant ovarian Mirvetuximab soravtansine significantly improved objective response rates compared with historical rates in patients with FRα-positive, platinum-resistant ovarian cancer in the phase 2 SORAYA trial. Here we present findings of combined expansion cohorts opened as part of the same study further evaluating the mirvetuximab soravtansine and bevacizumab combination as a novel, targeted Background: Mirvetuximab soravtansine (MIRV), an antibody-drug conjugate targeting folate receptor alpha (FRα), demonstrated an improvement in progression-free survival (PFS), overall response rate (ORR), and overall survival (OS) in patients (pts) with high-grade serous PROC compared to ICC (Moore K et al. Clinical Trial NCT05445778; Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Ovarian, Fallopian Tube, or Peritoneal Cancer (GLORIOSA) November 22, 2024 updated by: AbbVie. 67; 95% CI, 0. In the single-arm SORAYA trial (NCT04296890), which evaluated mirvetuximab soravtansine in bevacizumab (Avastin)-treated patients with platinum-resistant ovarian cancer, the agent demonstrated a About ELAHERE (mirvetuximab soravtansine-gynx) ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. This review summarizes current evidence of mirvetuximab soravtansine in platinum-resistant Patients who received mirvetuximab soravtansine not only lived longer when considering all standard chemotherapy medicines together, but also compared with each drug by itself in this trial. Safety Lead In. Date 14 Sep 2024. Patient-reported outcome results from phase III MIRASOL trial of mirvetuximab soravtansine vs. The labels for these new treatments include boxed warnings regarding ocular toxicity. Clinical Trial Design: This multinational, phase 3, Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer Moore KN et al. ELAHERE is the first treatment to show statistically significant improvements vs standard single-agent chemotherapy 1-3 *. The PFS assessed by both About the Phase 3 MIRASOL Trial MIRASOL is a global Phase 3 open-label, randomized, controlled trial that enrolled 453 patients to compare the efficacy and safety of mirvetuximab soravtansine with the investigator’s choice of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan) in the treatment of platinum Patients with FRα-positive, platinum-resistant ovarian cancer demonstrated positive improvements in progression-free survival (PFS), overall response rate (ORR), and overall survival (OS) with mirvetuximab soravtansine-gynx (Elahere) over investigator’s choice of chemotherapy in the phase 3 MIRASOL trial (NCT04209855) despite dose adjustments. 17. The exploration of mirvetuximab soravtansine as a potentially efficacious treatment in patients with advanced, high-grade, platinum-resistant epithelial ovarian, primary peritoneal, or fallopian Mirvetuximab soravtansine (mirvetuximab-s) is an antibody drug conjugate which has shown promise in the treatment of FRα-positive solid tumors in early phase clinical trials. Efficacy and safety of mirvetuximab soravtansine in patients with platinum Mirvetuximab soravtansine, an antibody-drug conjugate that binds with high affinity to folate receptor-α to provide tumor-directed delivery of the potent microtubule-disrupting agent DM4, has emerged as a promising investigational agent for the treatment of ovarian cancer, particularly in the settin FORWARD I: a Phase III study of mirvetuximab soravtansine versus Researchers are enrolling 453 patients in the phase III MIRASOL trial, which is comparing mirvetuximab soravtansine with physician's choice of a standard chemotherapy—paclitaxel, pegylated liposomal doxorubicin, or topotecan. To evaluate the safety and clinical activity of mirvetuximab soravtansine, an antibody-drug conjugate comprising a humanized anti-folate receptor alpha (FRα) monoclonal antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent, in combination with bevacizumab in patients with FRα-positive, platinum-resistant ovarian cancer. 65; 95% CI, 4. As part of the Phase 1b FORWARD II trial (NCT02606305), the combination of MIRV with bevacizumab (BEV) was evaluated in pts with FRα-positive (medium/high expression; ≥ 50%/ ≥75% of cells with PS2+ Official Title. N Engl J Med 2023;389:2162-74). It is being developed for the treatment of subjects. Mirvetuximab soravtansine-gynx is an anti-body–drug conjugate targeting folate receptor alpha (FRα), which is highly expressed in ovarian cancer. Opinion. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (MIRASOL) ClinicalTrials. In preclinical studies, IMGN853 showed excellent anti-tumor activity in FRα-positive tumors such as the EOC, uterine-serous-carcinoma (USC) and their xenograft models [29, 30]. 0001 § View the Data MIRV is an antibody-drug conjugate comprising an FRα-binding antibody, cleavable linker, and maytansinoid DM4 payload, a potent tubulin-targeting agent and is FDA approved in patients with platinum-resistant ovarian cancer who received 1-3 prior treatment regimens. 0001) and OS (HR, 0. 2. Mirvetuximab soravtansine (MIRV) is a first-in-class antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) and is indicated for the treatment of adult patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior systemic treatment regimens. Completion Date (Estimated): Background: Elevated FRα expression is a characteristic of several solid tumors, including epithelial ovarian cancer (EOC), thereby providing an attractive candidate for targeted therapeutic approaches. delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein . Mirvetuximab soravtansine (MIRV) in patients with Patient-reported outcomes (PROs) from the phase 3 MIRASOL trial (NCT04209855) showed that patients with folate receptor-alpha (FRα) positive, platinum-resistant ovarian cancer treated with mirvetuximab soravtansine (Elahere) had a better health-related quality of life (HRQOL) compared with the investigator’s choice of chemotherapy. 1 The review is supported by findings from the phase 3 MIRASOL trial (NCT04209855), and the FDA has set a FORWARD I (GOG 3011): A Phase III study of mirvetuximab soravtansine, a folate receptor alpha (FRa)-targeting antibody-drug conjugate, versus chemotherapy in patients with platinum-resistant ovarian cancer Kathleen N. Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus The FDA has granted regular approval to mirvetuximab soravtansine-gynx (Elahere) for adult patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal In this regard, mirvetuximab soravtansine (IMGN853) is an ADC comprising a humanized FRα-binding monoclonal antibody conjugated to the cytotoxic maytansinoid effector molecule DM4. It is being developed as maintenance therapy for the treatment of subjects with Mirvetuximab soravtansine-gynx (MIRV) is a first-in-class antibody-drug conjugate (ADC) comprising a FRα-binding antibody, a cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent. Mirvetuximab soravtansine has favorable benefit to risk profile for the treatment of folate Moore KN, Oza AM, Colombo N, et al. We conducted a phase 3, global, confirmatory, open-label, randomized, controlled trial to compare the efficacy and safety of MIRV with the investigator’s choice of chemotherapy in the treatment of Mirvetuximab soravtansine-gynx (MIRV) is a first-in-class, folate receptor alpha (FRα)-targeting antibody-drug conjugate with US Food and Drug Administration approval for GLORIOSA is designed to randomize 418 patients, 1:1 receiving intravenous MIRV at a dose of 6 mg/kg adjusted ideal body weight plus bevacizumab 15mg/kg every 3 weeks or receiving bevacizumab 15mg/kg Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate targeting folate receptor α (FRα). Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers (PICCOLO) a study on Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer. TRIAL PROTOCOL Maintenance with mirvetuximab soravtansine plus bevacizumab vs bevacizumab in FR α-high platinum-sensitive ovarian cancer David M O’Malley *,a, Tashanna Myers b, Pauline Wimberger c, Toon Van Gorp d, Andres Redondo e, David Cibula f, Shibani Nicum g, Manuel R odr igues h, Floor J Backes a, Joyce N Barlin i, Sharyn N Lewin Mirvetuximab soravtansine, an antibody-drug conjugate that binds with high affinity to folate receptor-α to provide tumor-directed delivery of the potent microtubule-disrupting agent DM4, has emerged as a promising investigational agent for the treatment of ovarian cancer, particularly in the settin FORWARD I: a Phase III study of mirvetuximab soravtansine versus Mirvetuximab Soravtansine הוא צימוד נוגדן-תרופה (ADC) המורכב מנוגדן קושר FRα, מקשר שניתן לפירוק ומייטנסינואיד DM4, שהוא חומר קטלני שמשתחרר רק כאשר התרופה מגיעה לגידולים ושם פועל נגד התאים הסרטניים. Completion Date (Estimated): Mirvetuximab soravtansine (mirvetuximab-s) is an antibody drug conjugate which has shown promise in the treatment of FRα-positive solid tumors in early phase clinical trials. to selectively kill cancer cells. In November 2022, the agent was granted accelerated approval Mirvetuximab soravtansine is an antibody-drug conjugate (ADC) comprising a FRα-binding antibody, cleavable linker, and maytansinoid DM4, a potent tubulin-targeting agent that has consistently shown clinically meaningful single agent activity, along with favorable tolerability, in patients with high FRα expressing tumors. Food and Drug Administration (FDA) Grants Full Approval for ELAHERE® (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients. Authors : Ursula A. Dosage and Administration General. 1 months)7 •Here, analysis of an extended data cutoff from the MIRASOL trial with a median follow-up of 20. stant ovarian cancer, available treatments have not shown a survival benefit. Official ABOUT THE PHASE 3 MIRASOL TRIALMIRASOL is a global Phase 3 open-label, randomized, controlled trial that enrolled 453 patients to compare the efficacy and safety of mirvetuximab soravtansine with Now, in a phase 2 trial, Dana-Farber gynecologic oncologist Rebecca L. Here, we report updated nonanalytical results based on a median This phase II trial tests how well mirvetuximab soravtansine in combination with olaparib works in treating patients with ovarian, peritoneal, and fallopian tube cancer that is responsive to platinum drug therapy (platinum sensitive) and positive for follate receptor-alpha (FRalpha) expression, but has come back (recurrent). Accumulating pre-clinical and clinical data supported the safety and anti-tumor Based on findings from the phase 3 MIRASOL trial, investigators plan to submit a supplemental biologics license application for mirvetuximab soravtansine in folate receptor Objectives Mirvetuximab soravtansine (MIRV) is a first-in-class ADC comprising a folate receptor-α (FRα)-binding antibody, cleavable linker, and maytansinoid DM4 payload. Trial design. Banerjee Subject About the PICCOLO trial PICCOLO is a single-arm Phase 2 trial evaluating the efficacy and safety of mirvetuximab soravtansine monotherapy in patients with FR-alpha high platinum-sensitive ovarian cancer who have received at least two prior lines of platinum containing therapy or have a documented platinum allergy. - MIRASOL Mirvetuximab soravtansine (IMGN853) is an antibody-drug conjugate that targets folate receptor α for tumor-directed delivery of the maytansinoid DM4, a potent microtubule-disrupting agent. The antibody (protein) part of MIRV targets tumors by. Patients were Mirvetuximab Soravtansine in ≥3-Line Recurrent Platinum-Sensitive Ovarian Cancer 1 1 Target Journal: Annals of Oncology 2 Article type: Original article – Phase 2 clinical trial 3 Title: The Efficacy and Safety of Mirvetuximab Soravtansine in FR -Positive, Third-Line 4 and Later, Recurrent Platinum-Sensitive Ovarian Cancer: The Single-Arm Phase 2 Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I. Patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (N=106) ELAHERE 6 Researchers are enrolling 453 patients in the phase III MIRASOL trial, which is comparing mirvetuximab soravtansine with physician's choice of a standard chemotherapy—paclitaxel, pegylated liposomal doxorubicin, or topotecan. Efficacy was evaluated in Study 0416 (MIRASOL, NCT04209855), a multicenter, open-label, active-controlled, randomized, two-arm trial in 453 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. The recommended dosage of mirvetuximab soravtansine is 6 mg/kg, Trial Management Phone: Email: Mirvetuximab Soravtansine (IMGN853) Dated 28 August 2020 Protocol Number IMGN853-0417 Confidential and Proprietary ImmunoGen, Inc. Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate composed of an antifolate receptor a (FRa) monoclonal antibody, a cleavable linker, and the may-tansinoid DM4 payload, a potent tubulin-targeting anti-mitotic agent. Presenters Lan Gardner ABOUT THE PHASE 3 MIRASOL TRIAL MIRASOL is a global Phase 3 open-label, randomized, controlled trial that enrolled 453 patients to compare the efficacy and safety of mirvetuximab soravtansine with the investigator's choice of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan) in the treatment of platinum Mirvetuximab soravtansine (mirvetuximab soravtansine-gynx; Elahere™) is an antibody-drug conjugate (ADC), which is comprised of a folate receptor α (FRα) directed antibody conjugated to a microtubule inhibitor via a cleavable linker. When mirvetuximab soravtansine binds to the FRα receptor, it is taken up by the cell where it releases a chemotherapy medicine called DM4 Konecny GE, Moore KN, Lebreton C, et al. Matulonis, U. Methods PICCOLO is a single arm, phase 2 study Mirvetuximab soravtansine-gynx (MIRV) is a novel antibody-drug conjugate targeting folate receptor alpha (FRα), which is overexpressed in epithelial ovarian cancer (EOC), with limited expression on normal tissues. : Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: Primary analysis of FORWARD I. Matulonis. None (Open label) 53 participants in 2 patient groups. Session Poster session 01. Lan Coffman, MD, PhD, discusses results and clinical Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I. 6 months vs 4. N Engl J Med 2023;389:2162-74) with a median follow-up time of 11. with recurrent platinum-sensitive, Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. 4 INVESTIGATOR’S AGREEMENT I have received and read the Investigator Brochure for mirvetuximab soravtansine. IC chemotherapy in participants with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients enrolled on the Mirvetuximab soravtansine (mirvetuximab-s) is an antibody drug conjugate which has shown promise in the treatment of FRα-positive solid tumors in early phase clinical trials. Salani, the Gynecologic Oncology Fellowship Director at University of California Los Angeles ELAHERE for patients. Here is how you know This decision was supported by findings from the phase 3 SORAYA trial (NCT04296890). Porter, MD, PhD, is investigating the combination of mirvetuximab soravtansine with pembrolizumab, an immune checkpoint inhibitor, in patients with relapsed serous endometrial cancer that is FRaphla-positive. Fehm , Pauline Wimberger , Holger Bronger , Data from phase I pooled expansion cohorts showed that mirvetuximab soravtansine (IMGN853) induced a solid response rate in patients with platinum-resistant ovarian cancer who had received 1 to 3 MIRASOL (GOG 3045/ENGOT-ov55) is a global study that opened for enrollment in December 2019. Furthermore, trastuzumab deruxtecan demonstrated promising results in the PanTumor02 trial, showing clinically meaningful efficacy across a broad spectrum of HER2 IMGN853(also known as Mirvetuximab soravtansine) consists of a FRα-binding antibody combined with a tubulin-disrupting drug, maytansinoid DM4 . A Phase II Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib in Recurrent Platinum Sensitive Ovarian, Peritoneal, and Fallopian Tube Cancer Mirvetuximab soravtansine is not yet approved for use outside a clinical trial. 1 Along with previously reported survival Mirvetuximab soravtansine improves outcomes over chemotherapy in patients with FRα+ platinum-resistant ovarian cancer, a phase 3 trial suggests. Initial results are expected As part of the phase 3 GLORIOSA study (NCT05445778), a clinical trial is evaluating the safety and efficacy of the antibody drug conjugate (ADC) mirvetuximab soravtansine (Elahere) as maintenance therapy for patients with folate receptor-alpha (FRα)-positive recurrent platinum-sensitive ovarian cancer. Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a Mirvetuximab soravtansine (MIRV) in patients with platinum-resistant ovarian cancer with high folate receptor alpha (FRα) expression: Characterization of antitumor activity in the SORAYA study. As part of the phase 1b/2 trial ([NCT02606305][1]), efficacy and safety of MIRV and carboplatin (carbo) were evaluated in patients with recurrent FRα-positive platinum sensitive ovarian cancer (PSOC) measured by MIRASOL is a global Phase 3 open-label, randomized, controlled trial that enrolled 453 patients to compare the efficacy and safety of mirvetuximab soravtansine with the investigator's choice of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan) in the treatment of platinum-resistant, high-grade serous ovarian PICCOLO is a single arm Phase 2 trial evaluating the efficacy and safety of mirvetuximab soravtansine monotherapy in patients with FR-alpha high platinum-sensitive ovarian cancer who have received Clinical trial Tumor board Video articles Images Pathology archives Corners of the world Commentary Letters ijgc. Oncol. investigator’s choice chemotherapy: analysis from the phase 3 MIRASOL trial The European Medicines Agency has accepted a marketing authorization application seeking the approval of mirvetuximab soravtansine-gynx for the treatment of patients with folate receptor alpha Mirvetuximab soravtansine in FRα-positive, platinum-resistant ovarian cancer. Crossref. Mirvetuximab soravtansine is an antibody-drug conjugate (ADC) comprising a FRα-binding antibody, cleavable linker, and the maytansinoid DM4, a potent Trial Name: A Study of Mirvetuximab Soravtansine vs. Topics Tumour Site Ovarian Cancer . Drug: Olaparib. 71, P = 0. In 2017, a phase I expansion study reported the first experience of MIRV in FRα-positive Objectives: Available single agent chemotherapies for platinum-resistant ovarian cancer have limited clinical activity and considerable toxicity. Clinical Trial NCT05887609; An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib May 3, 2024 updated by: University of Colorado, Denver. 2 months. Accumulating pre- Immunotherapy in gynecologic malignancies. PICCOLO is a phase 2, global, open-label, single-arm trial of MIRV as third-line or greater (≥3L) treatment in patients with FRα On November 14, 2022, the Food and Drug Administration granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc. The anti-FR-α monoclonal antibody present in mirvetuximab Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent. In the confirmatory phase 3 MIRASOL trial, mirvetuximab soravtansine significantly improved median progression-free survival, objective response rates, and median Mirvetuximab soravtansine achieved remarkable results in the MIRASOL trial, suggesting it as a potential new standard of care for folate receptor-α-positive platinum-resistant OC treatment. Nearly 40% of TNBC express high levels of FRα, suggesting that FRα directed therapy is a viable therapeutic strategy. bmj. 01, P = 0. com INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER ABSTRACT Mirvetuximab soravtansine-gynx (MIRV) is a conjugate of a folate receptor alpha (FRα)-directed antibody and the maytansinoid microtubule inhibitor, DM4. Methods. As part of the phase 3 GLORIOSA study (NCT05445778), a clinical trial is evaluating the safety and efficacy of the antibody drug conjugate (ADC) mirvetuximab soravtansine (Elahere) as maintenance therapy for patients with folate receptor-alpha (FRα)-positive recurrent platinum-sensitive ovarian cancer. PATIENTS AND METHODS Study design and patients FORWARD I was an open-label, randomized, phase III trial conducted in 12 countries (Trial registration 44O Safety and efficacy results in patients who received dose modifications in the phase III MIRASOL (GOG 3045/ENGOT-ov55) trial of mirvetuximab soravtansine vs investigator's choice chemotherapy (ICC) in platinum-resistant ovarian cancer (PROC) with high folate receptor-alpha expression Author: S. Mirvetuximab soravtansine-gynx (MIRV), a first-in-class antibody–drug conjugate that targets folate receptor We conducted a phase 3, global, confirmatory, open-label, randomized, controlled trial to compare the efficacy and safety of MIRV with the investigator’s choice of chemotherapy Objective The single-arm, phase II SORAYA trial (NCT04296890) of mirvetuximab soravtansine-gynx in folate receptor alpha (FRα)–high platinum-resistant ovarian cancer Methods: We conducted a phase 3, global, confirmatory, open-label, randomized, controlled trial to compare the efficacy and safety of MIRV with the investigator's choice of On November 14, 2022, the FDA granted accelerated approval to mirvetuximab soravtansine-gynx for treatment of adult patients with folate receptor-α (FRα)-positive, Background: Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent Mirvetuximab soravtansine-gynx (MIRV) is a conjugate of a folate receptor alpha (FRα)-directed antibody and the maytansinoid microtubule inhibitor, DM4. Patients received Skip to main content An official website of the United States government Here's how you know. An official website of the United States government. Full prescribing information for mirvetuximab soravtansine-gynx will be posted here. Interventional model. SORAYA is a global, single-arm, phase III study evaluating mirvetuximab soravtansine in adults with folate receptor alpha–high, platinum-resistant, high-grade, serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. with 35 For patients with FRα +, platinum-resistant ovarian cancer,. The ADC is being developed by ImmunoGen for the treatment of FRα expressing cancers. Patients with advanced, FRα-positive TNBC were enrolled on Background Mirvetuximab soravtansine is an antibody-drug conjugate comprising a folate receptor-alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin Mirvetuximab soravtansine, DM4 payload, is approved for the treatment of folate receptor (FRα) positive platinum-resistant ovarian cancer. The open-label, randomized FORWARD-1 trial evaluated mirvetuximab soravtansine vs chemotherapy investigator’s choice of chemotherapy in patients with platinum-resistant, FRα-positive advanced The sBLA for mirvetuximab soravtansine in FRα-positive, platinum-resistant ovarian cancer has been granted priority review by the FDA. There’s evidence that aggressive ovarian Updated Phase III MIRASOL Trial Results: Mirvetuximab Soravtansine vs Chemotherapy in Platinum-Resistant Ovarian Cancer with High Folate Receptor-Alpha Expression. 3-5. Primary purpose. 17), showing that these • No randomized phase 3 trial has shown an overall survival (OS) benefit of a novel therapy in platinum-resistant ovarian cancer (PROC) 1, 2 • Mirvetuximab soravtansine (MIRV) is an ADC comprising a FRα-binding antibody, cleavable linker, and maytansinoid DM4, a potent tubulin-targeting agent . Dr Coffman breaks down the findings from the phase III MIRASOL trial, and provides insight surrounding the treatment options and potential Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed. N Engl J Med 2023;389:2162–74. 2021 ; 32 (6): 757 – 765. Initial results are expected Now, data from the phase III MIRASOL trial demonstrate the activity of the antibody–drug conjugate mirvetuximab soravtansine in patients with folate-receptor-α (FRα)-high disease in this setting. Treatment: Drug: Mirvetuximab Soravtansine. Pts with PROC, 1-3 prior lines of therapy, and FRα positivity by Background: Mirvetuximab soravtansine (MIRV) is an ADC comprising a FRα-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent. Efficacy and safety of mirvetuximab soravtansine in patients with platinum Annals of Oncology shared a recent article by A. Mirvetuximab soravtansine is an antibody-drug conjugate (ADC) comprising a FRα-binding antibody, cleavable linker, and the maytansinoid DM4, a potent On March 22, 2024, the U. Here we report results from the Phase Ib combination trial FORWARD II (NCT02606305) designed to evaluate the safety, tolerability, and clinical activity of mirvetuximab soravtansine when co-administered with bevacizumab to Étude de phase III randomisée, en ouvert, évaluant le mirvétuximab soravtansine par rapport à la chimiothérapie choisie par l'investigateur dans le cancer avancé épithélial de haut grade de l'ovaire, péritonéal primitif ou des trompes de Fallope, résistant au platine, présentant une expression élevée des récepteurs alpha des folates. According to results from the phase 3 MIRASOL trial (NCT04209855), mirvetuximab soravtansine-gynx (Elahere) achieved a 35% reduction in the risk of disease progression or death compared with investigator’s choice of chemotherapy in patients with folate receptor alpha (FRα)-high, platinum-resistant ovarian cancer, according to a press briefing presentation during the In the review article by Bogani and colleagues, they meticulously explore the development of MIRV, an ADC targeting folate receptor α (FRα), in ovarian cancer. MIRV is made up of an antibody that binds to a specific protein (folate The FDA previously granted accelerated approval to mirvetuximab soravtansine as a treatment for patients with previously treated FRα–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal The GLORIOSA (NCT05445778) clinical trial will compare maintenance therapy with bevacizumab alone to maintenance therapy with bevacizumab plus a drug called mirvetuximab soravtansine-gynx (MIRV) to Mirvetuximab soravtansine (mirvetuximab-s) is an antibody drug conjugate which has shown promise in the treatment of FRα-positive solid tumors in early phase clinical trials. A, et al. U. 9; P < . Konner , The GLORIOSA (NCT05445778) clinical trial will compare maintenance therapy with bevacizumab alone to maintenance therapy with bevacizumab plus a drug called mirvetuximab soravtansine-gynx (MIRV) to determine which therapy leads to better results in patients with PSOC. 3. 2021 The FORWARD I trial described here will investigate the efficacy and tolerability of mirvetuximab soravtansine versus IC chemotherapy in patients with advanced, platinum-resistant ovarian cancer. During an ASCO news conference, Merry J. Herein, are the results of the first prospective phase II trial evaluating mirvetuximab-s in The SORAYA trial is a single-arm study examining mirvetuximab soravtansine in patients with platinum-resistant ovarian cancer whose tumors express high levels of FRα. 1. The randomized, open-label, phase III study FORWARD I compared MIRV and investigator's choice chemotherapy in patients with platinum-resistant In the primary analysis of the MIRASOL trial, MIRV demonstrated superior progression-free survival (PFS), objective response rate, and overall survival (OS), over ICC in patients (pts) with high-grade serous PROC (Moore K et al. 5 Lheureux S, Alqaisi H, Cohn DE, et al. November 25, 2024. 97; keratopathy risk ratio 0. PICCOLO is a single-arm Phase 2 study evaluating the efficacy and safety of MIRV in patients with PSOC, Mirvetuximab soravtansine is an ADC comprising an IgG1 monoclonal antibody against the folate receptor alpha (FRα) conjugated to the cytotoxic maytansinoid effector molecule DM4 that has shown promising clinical activity in patients with FR-α-positive ovarian cancer. 3 The main Mirvetuximab Soravtansine for the Treatment of Folate Receptor-Alpha Positive Persistent or Recurrent Endometrial Cancer. Methods: Patients received IMGN853 on day 1 of a 21-day cycle (once every 3 weeks dosing), with cycles repeated until Mirvetuximab Soravtansine chemical information summary. 1056/NEJMoa2309169 The new england The phase 2 PICCOLO trial demonstrated that mirvetuximab soravtansine (Elahere; AbbVie) is effective and tolerable in heavily pre-treated patients with folate receptor alpha-positive (FRα In a phase I trial of mirvetuximab in platinum-resistant EOC, the ORR was 26 Mirvetuximab soravtansine (Elahere™) is an antibody-drug conjugate comprising of an anti-FR-α monoclonal antibody that is linked with DM4, a maytansinoid microtubule inhibitor, through a gluthathione-reducible disulfide linker [52]. Patients are selected based on an FDA-approved Mirvetuximab soravtansine-gynx (Elahere) led to improvements in progression-free survival (PFS) and overall survival (OS) compared with chemotherapy in the treatment of patients with folate receptor α (FRα)–positive, platinum-resistant ovarian cancer, according to a press release on findings from a subset analysis of the phase 3 MIRASOL trial (NCT04209855). FORWARD I, a phase III study, evaluated the safety and efficacy of MIRV compared to chemotherapy in pts with PROC. Oza2, Nicoletta Colombo3, Ana Oaknin4, Giovanni Scambia5, Domenica Lorusso5,6, Robin Farias-Eisner7, Susana Banerjee8, Conleth Trial Management Phone: Email: Mirvetuximab Soravtansine (IMGN853) Dated 28 August 2020 Protocol Number IMGN853-0417 Confidential and Proprietary ImmunoGen, Inc. investigator's choice of chemotherapy in FRα positive . 1 In the multicenter, open-label The European Medicines Agency has accepted a marketing authorization application seeking the approval of mirvetuximab soravtansine-gynx for the treatment of patients with folate receptor alpha Mirvetuximab soravtansine (MIRV) is an ADC comprising a FRα-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent. ∙ Oaknin, A. Treatment with the folate receptor alpha (FRα)-targeted antibody-drug conjugate mirvetuximab soravtansine-gynx benefited patients with FRα-high, platinum-resistant ovarian cancer, even after multiple lines of prior therapy, according to an updated analysis of the SORAYA trial presented at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting on The FDA has granted priority review to the supplemental biologics license application seeking the conversion of the accelerated approval of mirvetuximab soravtansine-gynx in patients with FRα Trial Name: A Study of Mirvetuximab Soravtansine vs. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRα). Here's how you know. Mirvetuximab soravtansine (MIRV) is an antibody drug conjugate (ADC) comprising a FRα-binding antibody, cleavable linker, and maytansinoid DM4, a potent tubulin-targeting agent. Patient selection and NCCN Guidelines® V. Full Text. Here we report the findings of an expansion cohort study, opened as part of a Phase I trial of mirvetuximab soravtansine monotherapy (), designed to characterize receptor expression in archival and fresh biopsy samples obtained from a heterogeneous population of relapsed ovarian cancer patients with FRα-positive tumors. Patient-reported outcome results from phase III MIRASOL trial of mirvetuximab soravtansine versus investigator's choice of chemotherapy in FRα-positive Objective The single-arm, phase II SORAYA trial (NCT04296890) of mirvetuximab soravtansine-gynx in folate receptor alpha (FRα)–high platinum-resistant ovarian cancer (n=105 (efficacy-evaluable Objectives Mirvetuximab soravtansine (MIRV) is a first-in-class ADC comprising a folate receptor-α (FRα)-binding antibody, cleavable linker, and maytansinoid DM4 payload. Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I. Summary Eligibility for females ages 18 years and up (full criteria) Location at UCLA Dates. This study is in progress, not accepting new patients. ” Mirvetuximab soravtansine in FRα-positive, platinum-resistant ovarian cancer. Mirvetuximab soravtansine (ImmunoGen), an antibody drug conjugate (ADC) In this trial, researchers are trying to find out if using Bevacizumab on its own or in combination with Mirvetuximab Soravtansine is effective and safe as a maintenance treatment in platinum-sensitive ovarian cancer. Moore, MD. 1 In MIRASOL is a global Phase 3 open-label, randomized, controlled trial that enrolled 453 patients to compare the efficacy and safety of mirvetuximab soravtansine with the investigator’s choice of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan) in the treatment of platinum-resistant, high-grade serous ovarian Although the incidence of ocular events was higher than that previously reported for mirvetuximab soravtansine monotherapy in a large phase 3 trial , the exposure-adjusted rates were comparable (blurred vision risk ratio [triplet therapy to mirvetuximab soravtansine monotherapy] 1. This receptor is commonly Mirvetuximab soravtansine-gynx, a novel antibody-drug conjugate, significantly improved progression-free and overall survival in patients with platinum-resistant, recurrent ovarian cancers that express high levels of folate receptor–alpha (FR-alpha), according to the results of the phase III -MIRASOL trial presented at the 2023 ASCO Annual Meeting. 注）この治験に参加した患者さんは、ご自分で選択は出来ませんが、A群、B群のいずれかの治療を受けることになり Ocular toxicities are a unique set of adverse effects (AEs) associated with mirvetuximab soravtansine, as well as other antibody-drug conjugates (ADCs), Salani begins. 1 In a phase I trial of mirvetuximab in platinum-resistant EOC, the ORR was 26 Mirvetuximab soravtansine (Elahere™) is an antibody-drug conjugate comprising of an anti-FR-α monoclonal antibody that is linked with DM4, a maytansinoid microtubule inhibitor, through a gluthathione-reducible disulfide linker [52]. 1 In the multicenter, open-label Mirvetuximab soravtansine-gynx (MIRV) is a conjugate of a folate receptor alpha (FRα)-directed antibody and the maytansinoid microtubule inhibitor, DM4. Masking. Our ~50,000 employees around the world focus on discovering and delivering transformational medicines and products. I have read the ImmunoGen Protocol IMGN853-0417 and agree to In the MIRASOL trial, mirvetuximab soravtansine elicited significant and clinically meaningful survival improvements in PFS (HR, 0. Banerjee S, et al. 3 The authors discuss the results of the pivotal MIRASOL trial (NCT04209855), where MIRV was compared to single-agent chemotherapy in patients with FRα-high platinum-resistant ovarian cancer. This trial; Search. UA, Lorusso. Mirvetuximab soravtansine is an ADC comprising an IgG1 monoclonal antibody against the folate receptor alpha (FRα) conjugated to the cytotoxic maytansinoid effector molecule DM4 that has shown promising clinical activity in patients with FR-α-positive ovarian cancer. 20 FRa is a membrane protein that binds to and transports folate into cells. It is being developed as maintenance therapy for the. cxqcqo kagmti wauk bxva brqm biufccm tvjga iernk sap rcdh