RegulationPriority Review (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Conditional marketing approval (China), Orphan Drug (Australia), Priority Review (China)

Structure/Sequence

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Sequence Code 213022L

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Sequence Code 10079093H

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Clinical Trials associated with Mirvetuximab soravtansine

NCT07059845

/ Not yet recruitingPhase 2

A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Mirvetuximab Soravtansine in Subjects With Ovarian Cancer

Ovarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay.
Mirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 2 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. Approximately 320 participants will be enrolled in the study at 100 sites around the world.
Participants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused Bev alone. The total study duration will be approximately 40 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Start Date08 Sep 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT06890338

/ Not yet recruitingPhase 2

A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects With FRα-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC).
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). This is a single arm study in adult participants with advanced-stage Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) III-IV FRα-expressing serous EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States.
Participants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 years .
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Start Date28 Jul 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT06682988

/ RecruitingPhase 2

A Randomized Phase 2, Open-label Study of Mirvetuximab Soravtansine in Patients With Platinum-resistant Advanced High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-alpha Expression Testing 2 Schedules of Administration for Dose Optimization, With a Separate Cohort to Determine Starting Dose in Patients With Moderate Hepatic Impairment

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FR?).
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FR?). There are 2 cohorts in this study, the Randomized Phase 2 Cohort and the Hepatic Impairment Cohort. In the Randomized Phase 2 Cohort, participants are placed in 1 of 2 groups, called treatment arms. Each treatment arm receives MIRV on a different schedule (on day 1 every 21 days or on days 1 and 15 every 28 days). The Hepatic Impairment Cohort is designed to determine the starting dose of MIRV in patients with moderately abnormal liver function. Around 110 participants will be enrolled in the study at approximately 75 sites worldwide.
The total study duration will be approximately 24 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Start Date28 May 2025

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Mirvetuximab soravtansine

100 Translational Medicine associated with Mirvetuximab soravtansine

100 Patents (Medical) associated with Mirvetuximab soravtansine

122

Literatures (Medical) associated with Mirvetuximab soravtansine

01 Sep 2025·GYNECOLOGIC ONCOLOGY

Safety and efficacy of mirvetuximab soravtansine, a folate receptor alpha (FRα)–targeting antibody-drug conjugate (ADC), in combination with pembrolizumab in patients with platinum-resistant ovarian cancer

Article

Author: Xia, Yu ; Moore, Kathleen N ; Method, Michael ; Martin, Lainie P ; O'Malley, David M ; Matulonis, Ursula A ; Vergote, Ignace ; Birrer, Michael J ; Gilbert, Lucy ; Castro, Cesar M ; Stec, James

OBJECTIVE:

Evaluate the efficacy and safety of mirvetuximab soravtansine-gynx (MIRV) plus pembrolizumab in dose escalation and expansion cohorts of heavily pretreated patients with platinum-resistant ovarian cancer (PROC).

METHODS:

Participants with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease relapsed ≤6 months from last platinum-based treatment received MIRV (6 mg/kg adjusted ideal body weight) and pembrolizumab (200 mg) intravenously once every 3 weeks. Tumor FRα expression thresholds were ≥25 % (dose escalation cohort) and ≥50 % (dose expansion cohort) of cells with ≥2+ membrane staining intensity. The primary efficacy endpoint was objective response rate (ORR). Secondary endpoints included duration of response (DOR), progression-free survival (PFS), and safety.

RESULTS:

Fifty-six participants received the doublet. Median age was 62 years (range, 40-78). Twenty percent of participants had 3 prior lines of systemic treatment, 43 % had ≥4 prior lines, 43 % had prior bevacizumab exposure, and 41 % had prior PARP inhibitor exposure. Among 55 response-evaluable participants, ORR was 31 % (95 % CI, 19-45), median DOR was 8.0 months (95 % CI, 4.2-NR), and median PFS was 4.2 months (95 % CI, 2.8-5.6). Efficacy persisted in patients with multiple prior lines of treatment. Treatment-emergent adverse events were consistent with the profiles of each agent; the most common were diarrhea (all grades, 57 %; grade 3, 4 %), nausea (55 %; 5 %), and fatigue (50 %; 2 %). Treatment-emergent pneumonitis occurred in 25 % of participants, with grade ≥3 events occurring in 2 (4 %) participants.

CONCLUSIONS:

MIRV plus pembrolizumab demonstrated anti-cancer efficacy and a tolerable safety profile in heavily pretreated patients with PROC. However, the efficacy benefit may be mainly attributable to MIRV alone.

01 Jul 2025·CORNEA

Accuracy and Completeness of Large Language Models About Antibody–Drug Conjugates and Associated Ocular Adverse Effects

Article

Author: Mishra, Kapil ; Berkenstock, Meghan ; Kirupaharan, Nila ; Marshall, Rayna ; Francis, Jasmine H. ; Xu, Hannah ; Dalvin, Lauren A. ; Edalat, Camellia

Purpose::

The purpose of this study was to assess the accuracy and completeness of 3 large language models (LLMs) to generate information about antibody–drug conjugate (ADC)-associated ocular toxicities.

Methods::

There were 22 questions about ADCs, tisotumab vedotin, and mirvetuximab soravtansine that were developed and input into ChatGPT 4.0, Bard, and LLaMa. Answers were rated by 4 ocular toxicity experts using standardized 6-point Likert scales on accuracy and completeness. ANOVA tests were conducted for comparison between the 3 subgroups, followed by pairwise t-tests. Interrater variability was assessed with Fleiss kappa tests.

Results::

The mean accuracy score was 4.62 (SD 0.89) for ChatGPT, 4.77 (SD 0.90) for Bard, and 4.41 (SD 1.09) for LLaMA. Both ChatGPT (P = 0.03) and Bard (P = 0.003) scored significantly better for accuracy when compared with LLaMA. The mean completeness score was 4.43 (SD 0.91) for ChatGPT, 4.57 (SD 0.93) for Bard, and 4.42 (SD 0.99) for LLaMA. There were no significant differences in completeness scores between groups. Fleiss kappa assessment for interrater variability was good (0.74) for accuracy and fair (0.31) for completeness.

Conclusions::

All 3 LLMs had relatively high accuracy and completeness ratings, showing LLMs are able to provide sufficient answers for niche topics of ophthalmology. Our results indicate that ChatGPT and Bard may be slightly better at providing more accurate answers than LLaMA. As further research and treatment plans are developed for ADC-associated ocular toxicities, these LLMs should be reassessed to see if they provide complete and accurate answers that remain in line with current medical knowledge.

01 Jul 2025·GEBURTSHILFE UND FRAUENHEILKUNDE

Update Gynecologic Malignancies 2025 – Expert Opinion on Systemic Therapy for Early and Advanced Gynecological Cancers

Article

Author: Schulmeyer, Carla ; Emons, Julius ; Stübs, Frederik Alexander ; Hörner, Manuel ; Krückel, Annika ; Gocke, Julia ; Pöschke, Patrik ; Beckmann, Matthias W. ; Amann, Niklas

Abstract:

There have been major changes in the understanding of gynecologic malignancies in recent years, leading to new therapy options and subsequently to greater responsibilities for every professional treating those patients. The most significant therapeutic advances were achieved with checkpoint inhibitors (CPI), especially for endometrial and cervical cancer. In ovarian cancer the dominant and most important new substances are poly (ADP-ribose) polymerase inhibitors (PARPi). This review aims to summarize the latest studies and developments in the therapeutic landscape of endometrial, ovarian, and cervical cancer. The treatment of advanced endometrial cancer has changed significantly with the introduction of CPI such as dostarlimab (RUBY trial), durvalumab (DUO-E trial) and pembrolizumab (Keynote-868 trial). For ovarian cancer PARPi have shown substantial PFS benefits in key approval trials, including PRIMA for niraparib, PAOLA for olaparib, and ATHENA-MONO for rucaparib. These findings have established PARPi as the standard of care in maintenance therapy. Overall survival (OS) data for PRIMA and PAOLA are now available and are analyzed and placed into context in this article. Furthermore, mirvetuximab soravtansine is the first antibody-drug conjugate (ADC) approved in Germany for platinum-resistant ovarian cancer for patients with folate receptor alpha expression. The Keynote-A18 and BEATcc trials have opened new options for the utilization of immuno-oncology in cervical cancer treatment. Along with new therapeutic options, new biomarkers have also become part of daily clinical practice as predictive and prognostic factors as well as forming the basis for targeted personalized medicine.The use of CPI is revolutionizing the treatment of all gynecologic cancers and offers significant benefits for progression-free survival (PFS) and OS in most therapy regimens. With the increased use of ADCs, this is not the end of these developments. Therapy algorithms from a certified German oncology center are developed and presented in this article.

203

News (Medical) associated with Mirvetuximab soravtansine

28 Jul 2025

·pmlive.com

AbbVie’s Elahere granted MHRA approval to treat platinum-resistant ovarian cancer

AbbVie’s Elahere (mirvetuximab soravtansine) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat adults with ovarian, fallopian tube and primary peritoneal cancer. The antibody drug conjugate (ADC) has been authorised for use as a monotherapy in patients whose cancer cells have a protein on the surface known as folate receptor-alpha (FRα), which is highly expressed in around one third of ovarian cancer patients. Patients eligible for the drug will also have already received one to three prior systemic treatment regimens, and will have previously not responded to or are no longer responding to platinum-based chemotherapy. Approximately 7,500 people are diagnosed with ovarian cancer every year in the UK, making it the sixth most common cancer in women. Newly diagnosed patients usually receive surgery and platinum- based chemotherapy; however, 80% of those with advanced disease relapse and the majority eventually develop resistance to this treatment. AbbVie’s Elahere, which the company gained access to last year through its $10.1bn acquisition of ImmunoGen, is designed to target and kill tumour cells that express high levels of FRα while reducing impact on healthy tissue. The drug is administered once every three weeks as an intravenous infusion, and is now the first new treatment in ten years to be licensed in the UK for patients with platinum-resistant ovarian cancer. Rachael Millward, medical director, AbbVie UK, said: “This is an important development for women with advanced ovarian cancer, and in particular the underserved platinum-resistant patient population. “Following marketing authorisation, our priority now is to work with the National Institute for Health and Care Excellence (NICE) to provide all the necessary information for [its] appraisal of [Elahere].” The MHRA’s decision was supported by results from the late-stage MIRASOL trial, in which median progression-free survival was 5.62 months for Elahere-treated patients and 3.98 months for those receiving investigator’s choice chemotherapy. Median overall survival was also significantly longer for patients in the Elahere cohort compared to those who received chemotherapy, at 16.46 months versus 12.75 months. Julian Beach, MHRA interim executive director, healthcare quality and access, said: “We are committed to making innovative treatment options, like [Elahere], the first and only FRα directed ADC, available to patients as quickly as possible, ensuring our approval is underpinned by robust evidence of efficacy alongside the highest standards of safety.”

Drug ApprovalClinical ResultAcquisitionADC

09 Jun 2025

·www.prnewswire.com

TORL BioTherapeutics Announces Appointment of Anna Berkenblit, MD, MMSc, as Board Member

LOS ANGELES, June 9, 2025 /PRNewswire/ -- TORL BioTherapeutics LLC (TORL), a clinical-stage biotechnology company discovering and developing new antibody-based immunotherapies to improve and extend the lives of patients with cancer worldwide, today announced the appointment of Anna Berkenblit, MD, MMSc, as Board Member. "We are excited and proud to welcome Anna to TORL's Board. Dr. Berkenblit's contributions as a clinician and an industry leader have made a significant global impact on patients, most recently by leading the clinical development of a new targeted treatment option for a subset of patients with ovarian cancer," said Mark J. Alles, Chairman and Chief Executive Officer at TORL BioTherapeutics. Dr. Berkenblit has more than two decades of experience in clinical development of novel anticancer therapies. Currently, she is the Chief Scientific and Medical Officer of the Pancreatic Cancer Action Network (PanCAN), responsible for the organization's scientific and clinical strategies through sponsored studies, research grants, health data, business development and patient services. Prior to joining PanCAN, Dr. Berkenblit served as Chief Medical Officer at ImmunoGen where she led the development of mirvetuximab soravtansine-gynx, a first-in-class antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα). Under Dr. Berkenblit's leadership, mirvetuximab soravtansine-gynx received FDA approval for the treatment of patients with FRα -positive platinum-resistant ovarian cancer (PROC). "I am thrilled to add my experience and expertise developing novel cancer therapeutics to the TORL Board," said Dr. Berkenblit. "I look forward to working with the Board and Management to build on the Company's current discovery and development progress, and to establish TORL BioTherapeutics as a global leader among oncology-focused biotechnology companies." "Anna's clinical and industry perspectives come at a critical time for TORL, advancing the portfolio of novel potential first- and best-in-class antibody-based therapies, starting with our Claudin 6-targeted ADC TORL-1-23. We are very excited that she has joined the TORL Board," commented Board Member and Scientific Co-founder Dennis Slamon, MD, PhD, Professor of Medicine, and Chief of the Division of Hematology/Oncology at UCLA's David Geffen School of Medicine. Prior to her leadership role at ImmunoGen, Dr. Berkenblit was Senior Vice President, Clinical Development at H3 Biomedicine, and Vice President, Head of Clinical Research at Aveo Oncology. She also held positions of increasing responsibility at Wyeth/Pfizer including Vice President, Asset Team Leader. Throughout her career, Anna has led clinical development and oncology trials spanning early testing through large registration programs. "Dr. Berkenblit's experience successfully developing mirvetuximab soravtansine-gynx, a first-in-class targeted ADC in PROC, will directly benefit the TORL team as we continue our registrational Phase 2 CATALINA-2 trial of TORL-1-23 ADC for Claudin 6-positive PROC patients, currently TORL's top priority in 2025," said Dave Licata, Co-founder, Board Member, President and Chief Financial Officer of TORL BioTherapeutics. Dr. Berkenblit earned an MD from Harvard Medical School and a Master of Medical Sciences (MMSc) at Harvard/MIT Health Sciences & Technology. Her internship and residency were at Brigham and Women's Hospital and hematology/oncology fellowship at Beth Israel Deaconess Medical Center (BIDMC) where she continued as staff to focus on clinical research in gynecological and gastrointestinal malignancies. Subsequently, Anna led the BIDMC/Dana-Farber Harvard Cancer Center Phase 1 oncology clinical trial program prior to entering the biopharmaceutical industry. About Claudin 6 Claudin 6 (CLDN6) is overexpressed in multiple cancers with limited to no detectable expression observed in normal tissues, thus an ideal target for ADC development. CLDN6 is a transmembrane protein important for cell-to-cell connectivity in normal tissues during development but not in adult tissues. Overexpression of CLDN6 occurs in certain malignancies and is implicated in the initiation, progression, and metastasis of certain cancers, which include ovarian, non-small cell lung, endometrial, testicular and others. High expression correlates with shortened survival outcomes for patients with ovarian cancer. About TORL-1-23 TORL-1-23 is a first- and potentially best-in-class clinical-stage ADC for the treatment of CLDN6+ solid tumors. TORL-1-23 has received Fast Track Designation from the U.S. Food and Drug Administration. TORL BioTherapeutics is currently enrolling the pivotal Phase 2 CATALINA-2 study of TORL-1-23 in women with CLDN6+ PROC. Further details can be found at . About CATALINA-2 CATALINA-2 is a global, randomized, open-label Phase 2 study of novel CLDN6-targeted ADC TORL-1-23 in women with CLDN6+ PROC who have received one to three prior lines of therapy. The primary endpoint is objective response rate (ORR) per RECIST v1.1 by blinded independent central review. Secondary endpoints consist of duration of response, ORR by investigator assessment, progression-free survival, overall survival and safety. Further details can be found at . About TORL BioTherapeutics LLC TORL is a clinical-stage biopharmaceutical company developing new antibodies, both monoclonal antibodies and ADCs, with the goal of transforming the lives of patients challenged with a variety of human malignancies. Through a strategic partnership with the Slamon Research Lab at UCLA, TORL has exclusive development and commercial rights to a large program of biologics-based drugs for new, promising and novel cancer targets. SOURCE TORL Biotherapeutics LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 1Fast TrackExecutive ChangeDrug Approval

03 Jun 2025

·pipelinereview.com

Lilly presents first clinical data for its investigational, next-generation FRα targeting ADC in platinum-resistant ovarian cancer at the 2025 ASCO Annual Meeting

INDIANAPOLIS, IN, USA I June 2, 2025 I Eli Lilly and Company (NYSE: LLY ) today announced new Phase 1 data showing that its folate receptor alpha (FRα) antibody-drug conjugate (ADC) (LY4170156) demonstrated an encouraging safety profile and anti-tumor activity across dose and FRα expression levels in women with heavily pre-treated platinum-resistant ovarian cancer, including patients previously treated with mirvetuximab soravtansine. A preliminary overall objective response rate (ORR) of 55% was observed at the potential recommended Phase 2 dose of 4 mg/kg. Lilly’s FRα targeting ADC is composed of an Fc-silent, FRα specific humanized monoclonal antibody linked to exatecan, a topoisomerase I inhibitor, via a proprietary cleavable polysarcosine linker. These data will be presented today in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting. “ADCs have begun to change the treatment paradigm for some women with ovarian cancer, but a large proportion of patients still have a significant need for new therapies that improve outcomes regardless of FRα expression level,” said Isabelle Ray-Coquard, M.D., Ph.D., president of the ENGOT (European Network of Gynecological Oncology Trial) group, medical oncologist at the Centre Léon Bérard Lyon France and principal investigator for the trial. “These initial data show activity across all doses and levels of FRα expression, including in patients previously treated with a FRα targeting treatment. Taken together with the emerging safety and tolerability profile, these data demonstrate early potential to meaningfully improve outcomes for women living with advanced ovarian cancer.” As of the March 9, 2025 data cutoff, the study enrolled 95 participants with high-grade serous ovarian cancer across four dose levels (2 – 6 mg/kg). Patients received a median of five prior systemic regimens (range 1-10), and 15% were previously treated with mirvetuximab soravtansine. Among the 95 patients, 51% had tumors with FRα expression less than 75%, 34% had FRα expression of 75% or higher, and 16% had expression results pending. Key endpoints were safety, pharmacokinetics, and anti-tumor activity per RECIST v1.1. Efficacy results demonstrate responses at all dose levels, across all FRα expression levels, including in patients who progressed on prior mirvetuximab soravtansine. In the 58 efficacy-evaluable patients (37 patients remain ongoing prior to first response assessment and were therefore not yet efficacy-evaluable at the time of the data cutoff), the ORR was 45% (26/58 patients), and the disease control rate was 74% (43/58). At the potential recommended Phase 2 dose of 4 mg/kg, the ORR was 55% (11/20 patients). The most common treatment-emergent adverse events across all dose levels included nausea (64%), anemia (40%), fatigue (32%), vomiting (32%), diarrhea (28%), and neutropenia (27%). Treatment-emergent neuropathy and ocular toxicity has not been observed to date. No maximum tolerated dose has been established. “We are excited to share these first clinical data for our FRα targeting ADC, demonstrating a promising tolerability and efficacy profile across all FRα expression levels,” said David Hyman, M.D., Chief Medical Officer, Lilly. “Based on these results, we believe there is the potential to significantly expand the number of ovarian cancer patients who could benefit from a FRα ADC. We are now focused on rapidly advancing this potential new medicine into registrational Phase 3 clinical trials.” For more information on Lilly’s oncology pipeline click here . About LY4170156 LY4170156 is an investigational, next-generation antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα). FRα is a cell-surface glycoprotein encoded by the gene FOLR1 that binds to the essential nutrients folic acid and reduced folates, bringing them into cells to facilitate cell division and growth. 1,2 FRα is overexpressed in many solid tumors such as ovarian, non-small cell lung, and colorectal cancers. 1,3,4 LY4170156 was designed to target FRα across expression levels with an improved therapeutic index. LY4170156 is composed of an Fc-silent, FRα specific humanized monoclonal antibody linked to exatecan, a topoisomerase I inhibitor, via a proprietary cleavable polysarcosine linker (PSARlink™). PSARlink’s unique structure “masks” the cytotoxic molecules enabling them to stay in the body longer, providing the potential to broaden the therapeutic index of ADCs. LY4170156 is currently being studied in patients with ovarian cancer as well as other FRα-expressing solid tumors, NCT06400472 . About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We’ve been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world’s most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer’s disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we’re motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news , or follow us on Facebook , Instagram , and LinkedIn . P-LLY SOURCE: Eli Lilly

Clinical ResultPhase 1ASCOADC

100 Deals associated with Mirvetuximab soravtansine

External Link

KEGG	Wiki	ATC	Drug Bank
D10954	Mirvetuximab soravtansine	-	DB12489

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Fallopian Tube Carcinoma	United Kingdom	AbbVie Ltd.	24 Jul 2025
Ovarian Cancer	United Kingdom	AbbVie Ltd.	24 Jul 2025
Primary peritoneal carcinoma	United Kingdom	AbbVie Ltd.	24 Jul 2025
Folate receptor-alpha positive, platinumresistant epithelial ovarian cancer	United States	ImmunoGen, Inc.	14 Nov 2022
Folate receptor-alpha positive, platinumresistant fallopian tube cancer	United States	ImmunoGen, Inc.	14 Nov 2022
Folate receptor-alpha positive, platinumresistant primary peritoneal cancer	United States	ImmunoGen, Inc.	14 Nov 2022
Platinum-Resistant Epithelial Ovarian Carcinoma	United States	ImmunoGen, Inc.	14 Nov 2022
Platinum-Resistant Fallopian Tube Carcinoma	United States	ImmunoGen, Inc.	14 Nov 2022
Platinum-Resistant Primary Peritoneal Carcinoma	United States	ImmunoGen, Inc.	14 Nov 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	NDA/BLA	Canada	AbbVie, Inc.	01 Mar 2025
Platinum-sensitive epithelial ovarian cancer	Phase 3	United States	AbbVie, Inc.	27 Dec 2022
Platinum-sensitive epithelial ovarian cancer	Phase 3	China	AbbVie, Inc.	27 Dec 2022
Platinum-sensitive epithelial ovarian cancer	Phase 3	Japan	AbbVie, Inc.	27 Dec 2022
Platinum-sensitive epithelial ovarian cancer	Phase 3	Argentina	AbbVie, Inc.	27 Dec 2022
Platinum-sensitive epithelial ovarian cancer	Phase 3	Australia	AbbVie, Inc.	27 Dec 2022
Platinum-sensitive epithelial ovarian cancer	Phase 3	Belgium	AbbVie, Inc.	27 Dec 2022
Platinum-sensitive epithelial ovarian cancer	Phase 3	Bulgaria	AbbVie, Inc.	27 Dec 2022
Platinum-sensitive epithelial ovarian cancer	Phase 3	Canada	AbbVie, Inc.	27 Dec 2022
Platinum-sensitive epithelial ovarian cancer	Phase 3	Czechia	AbbVie, Inc.	27 Dec 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS \| Literature Manual	Not Applicable	Platinum-Resistant Ovarian Carcinoma	18	索米妥昔单抗	dzjksnrbdj(ucfmcvxosk) = bqkuholgii yqugsqpnvq (zrkdevmucc ) View more	Positive	31 Mar 2025
NCT04209855 (MIRASOL, PRNewswire \| NEWS) Manual	Phase 3	Folate receptor-alpha positive, platinumresistant epithelial ovarian cancer FRα expression	453	ELAHERE (mirvetuximab soravtansine-gynx)	ahmjexkgdm(bvtrksomme) = goarjotaxm sndchhuiid (epugktnuwo, 4.34 - 5.88) View more	Positive	15 Mar 2025
NCT04209855 (MIRASOL, PRNewswire \| NEWS) Manual	Phase 3		453	Chemotherapy	ahmjexkgdm(bvtrksomme) = apxyxzrntd sndchhuiid (epugktnuwo, 2.86 - 4.47) View more	Positive	15 Mar 2025
NCT05041257 (PICCOLO, Pubmed \| Ann Oncol) Manual	Phase 2	Ovarian Cancer Third line FRα expression	79	Mirvetuximab Soravtansine	soauoakgvy(vraqohyvqq) = tbrhjfkbsb espqyhgphn (fvwqcywuko, 40.4 - 63.3) Met View more	Positive	01 Nov 2024
SGO2024	Not Applicable	Toxicity high folate-receptor alpha expression (FOLR)	-	Mirvetuximab soravtansine	yhugkhhosj(dxlqnrtkms) = 9 % experienced grade 3 ocular adverse reactions iyfaxbabkr (kxaxwuvdlc ) View more	-	01 Nov 2024
NCT05041257 (PICCOLO, ESMO2024) Manual	Phase 2	Primary peritoneal carcinoma \| Platinum-Sensitive Ovarian Carcinoma \| Fallopian Tube Carcinoma Third line FRα expression	79	Mirvetuximab soravtansine (MIRV) 6 mg/kg	ywsybxhgwi(uyiujjtkeo) = fpjlwvsvck xgvncmxbsv (mapbhpmegq, 40.4 - 63.3) View more	Positive	15 Sep 2024
NCT04209855 (MIRASOL, ESMO2024) Manual	Phase 3	Platinum-Resistant Ovarian Carcinoma FRα expression	453	Mirvetuximab soravtansine (MIRV) 6 mg/kg	ryzjrngbcd(jfidmfzrhm) = obhylptkly fcigxdaxhg (omugbnbwxe, 4.3 - 6.0) View more	Positive	14 Sep 2024
NCT04209855 (MIRASOL, ESMO2024) Manual	Phase 3	Platinum-Resistant Ovarian Carcinoma FRα expression	453	Investigator’s choice chemotherapy (ICC): paclitaxel (PAC), pegylated liposomal doxorubicin (PLD), or topotecan (Topo)	ryzjrngbcd(jfidmfzrhm) = zknbpjlena fcigxdaxhg (omugbnbwxe, 2.9 - 4.5) View more	Positive	14 Sep 2024
NCT04296890 (SORAYA \| Study 0417 (SORAYA), CTgov)	Phase 3	Platinum-Resistant Fallopian Tube Carcinoma \| Platinum-Resistant Primary Peritoneal Carcinoma \| Peritoneal Neoplasms ... View more	106	Mirvetuximab Soravtansine	ljjrwvetnw = hjvsggkhtg keduddmodq (rookzwklxv, ctjodiuidu - fxmdieiwju) View more	-	07 Aug 2024
NCT04209855 (SORAYA \| MIRASOL \| SORAYA study (002) \| MIRASOL (GOG 3045/ENGOT-ov55), CTgov)	Phase 3	Platinum-Resistant Fallopian Tube Carcinoma \| Platinum-Resistant Primary Peritoneal Carcinoma \| Peritoneal Neoplasms ... View more	453	Mirvetuximab Soravtansine (Mirvetuximab Soravtansine)	afzxzixeiv(hlekysgqhi) = spznuazylz rgjkzrlpku (ydwrdezxwr, lskdmtmlvc - sqnopeovfj) View more	-	01 Aug 2024
	Phase 3		453	Pegylated liposomal doxorubicin+Paclitaxel+Topotecan (Investigator's Choice (IC) Chemotherapy)	afzxzixeiv(hlekysgqhi) = ppheroikas rgjkzrlpku (ydwrdezxwr, rzfnobcfbv - qdmaixgmbt) View more	-	01 Aug 2024
NCT05445778 (GLORIOSA, Pubmed \| Future Oncol) Manual	Phase 3	Platinum-Sensitive Ovarian Carcinoma Maintenance FRα-high	-	Mirvetuximab soravtansine plus bevacizumab	nifablnvbz(kxozivghgt) = gnrzbclgcs jbpxkrordr (txzaqodyew, 41 - 89) View more	Positive	31 Jul 2024
NCT04209855 (MIRASOL (GOG 3045/ENGOT-ov55), ASCO2024)	Phase 3	Platinum-Resistant Ovarian Carcinoma folate receptor-alpha (FRα)	453	Mirvetuximab soravtansine (MIRV) 6 mg/kg	mngcbbgvfr(kmrzdiujdc): HR = 0.62 View more	Positive	24 May 2024
NCT04209855 (MIRASOL (GOG 3045/ENGOT-ov55), ASCO2024)	Phase 3		453	Investigator’s choice chemotherapy (ICC)	mngcbbgvfr(kmrzdiujdc): HR = 0.62 View more	Positive	24 May 2024

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