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

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

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 Date24 Nov 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT07059845

/ 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 Date07 Oct 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 (FRα).
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). 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

126

Literatures (Medical) associated with Mirvetuximab soravtansine

01 Oct 2025·Die Ophthalmologie

Korneale Nebenwirkungen von Mirvetuximab-Soravtansin

Review

Author: Schmidinger, Gerald ; Khoramnia, Ramin

01 Oct 2025·INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER

Article

Author: Smick, Alexandra H ; Salani, Ritu ; Chase, Dana M ; Silverstein, Jordyn ; Konecny, Gottfried ; Brennan, Lindsay

01 Sep 2025·INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER

Review

Author: Wang, Ying ; Jia, Li ; Chen, Mi ; He, Jinhui

218

News (Medical) associated with Mirvetuximab soravtansine

31 Oct 2025

·www.prnewswire.com

AbbVie Reports Third-Quarter 2025 Financial Results

Reports Third-Quarter Diluted EPS of $0.10 on a GAAP Basis, a Decrease of 88.6 Percent; Adjusted Diluted EPS of $1.86, a Decrease of 38.0 Percent; These Results Include an Unfavorable Impact of $1.50 Per Share Related to Acquired IPR&D and Milestones Expense Delivers Third-Quarter Net Revenues of $15.776 Billion, an Increase of 9.1 Percent on a Reported Basis or 8.4 Percent on an Operational Basis Third -Quarter Global Net Revenues from the Immunology Portfolio Were $7.885 Billion, an Increase of 11.9 Percent on a Reported Basis, or 11.2 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $4.708 Billion; Global Rinvoq Net Revenues Were $2.184 Billion; Global Humira Net Revenues Were $993 Million Third -Quarter Global Net Revenues from the Neuroscience Portfolio Were $2.841 Billion, an Increase of 20.2 Percent on a Reported Basis, or 19.6 Percent on an Operational Basis; Global Vraylar Net Revenues Were $934 Million; Global Botox Therapeutic Net Revenues Were $985 Million; Combined Global Ubrelvy and Qulipta Net Revenues Were $642 Million Third -Quarter Global Net Revenues from the Oncology Portfolio Were $1.682 Billion, a Decrease of 0.3 Percent on a Reported Basis, or 1.3 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $706 Million; Global Venclexta Net Revenues Were $726 Million; Global Elahere Net Revenues Were $170 Million Third -Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.193 Billion, a Decrease of 3.7 Percent on a Reported Basis, or 4.2 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $637 Million; Global Juvederm Net Revenues Were $253 Million Raises 2025 Adjusted Diluted EPS Guidance Range from $10.38 - $10.58 to $10.61 - $10.65, which Includes an Unfavorable Impact of $2.05 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the Third Quarter 2025 Announces 2026 Dividend Increase of 5.5 Percent, Beginning with Dividend Payable in February 2026 NORTH CHICAGO, Ill., Oct. 31, 2025 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the third quarter ended September 30, 2025. "AbbVie continues to deliver outstanding results, with significant momentum across key areas of our portfolio. We are also making great progress advancing our pipeline and investing in innovation to support AbbVie's long-term growth," said Robert A. Michael, chairman and chief executive officer, AbbVie. "Based upon the strength of our business and its promising outlook, we are once again raising our quarterly cash dividend." Third -Quarter Results Worldwide net revenues were $15.776 billion, an increase of 9.1 percent on a reported basis, or 8.4 percent on an operational basis. Global net revenues from the immunology portfolio were $7.885 billion, an increase of 11.9 percent on a reported basis, or 11.2 percent on an operational basis. Global Skyrizi net revenues were $4.708 billion, an increase of 46.8 percent on a reported basis, or 46.0 percent on an operational basis. Global Rinvoq net revenues were $2.184 billion, an increase of 35.3 percent on a reported basis, or 34.1 percent on an operational basis. Global Humira net revenues were $993 million, a decrease of 55.4 percent on a reported basis, or 55.7 percent on an operational basis. Global net revenues from the neuroscience portfolio were $2.841 billion, an increase of 20.2 percent on a reported basis, or 19.6 percent on an operational basis. Global Vraylar net revenues were $934 million, an increase of 6.7 percent. Global Botox Therapeutic net revenues were $985 million, an increase of 16.1 percent on a reported basis, or 15.8 percent on an operational basis. Global Ubrelvy net revenues were $354 million, an increase of 31.5 percent. Global Qulipta net revenues were $288 million, an increase of 64.1 percent on a reported basis, or 63.1 percent on an operational basis. Global net revenues from the oncology portfolio were $1.682 billion, a decrease of 0.3 percent on a reported basis, or 1.3 percent on an operational basis. Global Imbruvica net revenues were $706 million, a decrease of 14.8 percent. Global Venclexta net revenues were $726 million, an increase of 7.1 percent on a reported basis, or 4.9 percent on an operational basis. Global Elahere net revenues were $170 million, an increase of 23.3 percent on a reported basis, or 22.4 percent on an operational basis. Global net revenues from the aesthetics portfolio were $1.193 billion, a decrease of 3.7 percent on a reported basis, or 4.2 percent on an operational basis. Global Botox Cosmetic net revenues were $637 million, a decrease of 4.9 percent on a reported basis, or 5.4 percent on an operational basis. Global Juvederm net revenues were $253 million, a decrease of 2.2 percent on a reported basis, or 3.2 percent on an operational basis. On a GAAP basis, gross margin in the third quarter was 66.4 percent. The adjusted gross margin was 83.9 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 22.6 percent of net revenues. The adjusted SG&A expense was 21.6 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 14.7 percent of net revenues. The adjusted R&D expense was 14.3 percent of net revenues. Acquired IPR&D and milestones expense was 17.0 percent of net revenues. On a GAAP basis, operating margin in the third quarter was 12.1 percent. The adjusted operating margin was 30.9 percent. Net interest expense was $667 million. On a GAAP basis, the tax rate in the quarter was 73.7 percent. The adjusted tax rate was 24.5 percent. Diluted earnings per share (EPS) in the third quarter was $0.10 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $1.86. These results include an unfavorable impact of $1.50 per share related to acquired IPR&D and milestones expense. Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. Recent Events AbbVie announced the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) that updates the indication statement for Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD). The updated indication statement allows the use of Rinvoq prior to the use of tumor necrosis factor (TNF) blocking agents in patients for whom use of these treatments is clinically inadvisable and who have received at least one approved systemic therapy. AbbVie announced positive topline results from the second of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of Rinvoq in adult and adolescent patients with severe alopecia areata (AA). In the study, Rinvoq achieved the primary endpoint, demonstrating that 45.2% and 55.0% of patients with severe AA treated with Rinvoq 15 mg and 30 mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by the severity of alopecia tool (SALT) score ≤ 20. Key secondary endpoints, including improvements in eyebrows and eyelashes, as well as the percentage of subjects with 90% or more scalp coverage (SALT ≤ 10) and complete scalp hair coverage (SALT=0) at week 24, were also met. Rinvoq's safety profile in AA was generally consistent with that in approved indications, and no new safety signals were identified in this study. AbbVie announced topline results from two replicate Phase 3 studies evaluating the efficacy and safety of Rinvoq 15 mg in adult and adolescent patients living with non-segmental vitiligo (NSV). In the studies, Rinvoq achieved the co-primary endpoints of 50% reduction in total Vitiligo Area Scoring Index (T-VASI 50) from baseline and 75% reduction in Facial Vitiligo Area Scoring Index (F-VASI 75) from baseline at week 48. Additionally, across both studies, statistically significant differences were observed with Rinvoq versus placebo in key ranked secondary endpoints, including F-VASI 50 at week 48. The safety profile of Rinvoq in both studies was generally consistent with that observed in approved indications. AbbVie announced positive topline results from the Phase 3b/4 head-to-head SELECT-SWITCH study evaluating the efficacy and safety of Rinvoq compared to Humira (adalimumab) in adult patients with moderate to severe rheumatoid arthritis (RA), who had an inadequate response or intolerance to a single TNF inhibitor other than Humira. In the study, Rinvoq demonstrated superiority versus Humira in the primary endpoint of achieving low disease activity and demonstrated superiority for additional ranked secondary endpoints at week 12. Rinvoq's safety profile was consistent with previously reported studies, with no new safety risks identified. AbbVie announced that it completed its acquisition of Capstan Therapeutics. The acquisition adds a potential first-in-class in vivo targeted lipid nanoparticle (tLNP) anti-CD19 CAR-T therapy candidate for B cell-mediated autoimmune diseases as well as a proprietary tLNP platform designed to deliver RNA payloads, such as mRNA, capable of engineering specific cell types in vivo. AbbVie announced that it submitted a New Drug Application (NDA) to the FDA for tavapadon, a novel selective dopamine D1/D5 receptor partial agonist for the treatment of Parkinson's disease (PD). The submission is supported by data from the Phase 3 TEMPO program, which demonstrated symptomatic improvement across the PD spectrum. If approved, tavapadon will enhance AbbVie's position in PD by providing patients with a once daily oral treatment option. AbbVie announced positive topline results from the Phase 2 ELATE trial evaluating the safety and efficacy of Botox (onabotulinumtoxinA) for the treatment of upper limb essential tremor. Botox met the primary endpoint in the Phase 2 trial, demonstrating a statistically significant improvement from baseline in the Tremor Disability Scale-Revised (TREDS-R) total unilateral score compared to placebo. The trial also met all six secondary endpoints. Results from safety analyses were generally consistent with the well-established safety profile of Botox. AbbVie announced that it completed its acquisition of Gilgamesh Pharmaceuticals' lead investigational candidate, bretisilocin. Bretisilocin is a novel, short-acting serotonin (5-HT)2A receptor agonist and 5-HT releaser psychedelic compound with best-in-class potential, which is currently in Phase 2 clinical development for the treatment of patients with moderate-to-severe major depressive disorder (MDD). Positive topline results from a Phase 2a study of bretisilocin in MDD were previously announced, demonstrating a clinically impactful and statistically significant reduction in severity of depressive symptoms versus low dose active comparator, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. AbbVie announced submission of a new Biologics License Application (BLA) to the FDA for approval of pivekimab sunirine (PVEK), an investigational antibody-drug conjugate (ADC), for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN). The submission is based on data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of PVEK in BPDCN. BPDCN is a rare and aggressive blood cancer with significant need for innovative treatment options for both newly diagnosed patients and for those whose prior treatments have resulted in relapsed or refractory (R/R) disease. At the European Society for Medical Oncology (ESMO) Congress, AbbVie presented new data from its ADC portfolio in patients with difficult-to-treat tumor types. Highlights included three oral presentations for Temab-A (telisotuzumab adizutecan) as a monotherapy or in combination across advanced, solid tumors, as well as new analysis of ABBV-706 for the treatment of R/R small cell lung cancer (SCLC). At the Society of Hematologic Oncology (SOHO) Annual Meeting, AbbVie announced updated results from the Phase 2 EPCORE NHL-6 trial evaluating the feasibility of dosing and monitoring patients in the outpatient setting for the first full dose of Epkinly (epcoritamab) monotherapy in adult patients with R/R diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of systemic therapy. Results from the study demonstrated that the incidence and severity of cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) following treatment with epcoritamab were consistent with previous epcoritamab studies in R/R DLBCL. AbbVie announced plans to launch Elahere (mirvetuximab soravtansine-gynx) in the U.K. at a list price equal to the U.S., reflecting the advanced innovation and value of the treatment for adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens. AbbVie is committed to ensuring that developed nations fully recognize the value of our medicines in improving patient outcomes, consistent with the level of recognition in the U.S. Allergan Aesthetics announced several marketing initiatives, which include a new national, multichannel, campaign highlighting Botox Cosmetic's (onabotulinumtoxinA) market leadership, legacy and real-world patient experiences; the launch of a consumer education campaign that is aimed at providing clear, factual information about hyaluronic acid (HA) injectable fillers and the natural-looking results they can achieve; and the launch of SkinVive by Juvederm into 35 new markets. AbbVie announced it broke ground on a $195 million state-of-the-art active pharmaceutical ingredient (API) facility that will manufacture immunology, oncology and neuroscience medicines. This North Chicago, Ill. facility is expected to be fully operational and serving patients by 2027. The company also announced the start of construction on a $70 million expansion at its AbbVie Bioresearch Center (ABC) in Worcester, Mass., which will increase biologics manufacturing for immunology and oncology medicines. These projects are part of AbbVie's previously announced commitment to invest more than $10 billion of capital in the U.S. to broadly support innovation and expand critical manufacturing capabilities and capacity. Full-Year 2025 Outlook AbbVie is raising its adjusted diluted EPS guidance for the full year 2025 from $10.38 - $10.58 to $10.61 - $10.65, which includes an unfavorable impact of $2.05 per share related to acquired IPR&D and milestones expense incurred year-to-date through the third quarter 2025. The company's 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the third quarter of 2025, as both cannot be reliably forecasted. Company Declares Dividend Increase of 5.5 Percent AbbVie is announcing today that its board of directors declared an increase in the company's quarterly cash dividend from $1.64 per share to $1.73 per share beginning with the dividend payable on February 17, 2026 to shareholders of record as of January 16, 2026. This reflects an increase of approximately 5.5 percent, continuing AbbVie's strong commitment to returning cash to shareholders through a growing dividend. Since the company's inception in 2013, AbbVie has increased its quarterly dividend by more than 330 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years. About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, neuroscience, oncology, and eye care - and products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X (formerly Twitter), Facebook,Instagram, YouTube or LinkedIn. Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our third-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central Time. Non-GAAP Financial Results Financial results for 2025 and 2024 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with generally accepted accounting principles in the United States (GAAP) and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2Phase 3Financial StatementAcquisition

31 Oct 2025

·firstwordpharma.com

Skyrizi, Rinvoq continue to fuel AbbVie's immunology surge in Q3

Soaring demand for AbbVie's immunology heavyweights Skyrizi and Rinvoq powered its third-quarter results ahead of forecasts. Together, the two therapies generated roughly half the drugmaker's total quarterly revenue of $15.8 billion, which was up 9.1% year-on-year, company officials said Friday.Skyrizi brought in $4.7 billion during the quarter, a nearly 47% jump from the same time last year, edging past forecasts of roughly $4.5 billion. Rinvoq posted $2.2 billion in sales, up a little over 35% year-over-year and slightly above projections.AbbVie's immunology division overall brought in $7.9 billion, up almost 12%, helping offset the ongoing decline of Humira, which saw sales cut in half to $993 million amid intensifying biosimilar competition. AbbVie has said it expects Skyrizi and Rinvoq to bring in a combined $31 billion in sales by 2027, including $20 billion from Skyrizi and $11 billion from Rinvoq."Investors will continue to monitor the competitive landscape for key indications, such as (inflammatory) bowel disease, but we continue to see Skyrizi and Rinvoq driving strong near-term growth for the company," remarked William Blair analyst Matt Phipps.The neuroscience division posted another strong quarter, with sales climbing about 20% to $2.8 billion. Antipsychotic medicine Vraylar rose 6.7% to $934 million, while migraine treatments Ubrelvy and Qulipta saw sales growing 31.5% and 64.1% to $354 million and $288 million, respectively. Chief Commercial Officer Jeff Stewart also highlighted the "very impressive" launch trajectory of its new Parkinson's disease therapy Vyalev, approved a little over a year ago, which generated $138 million in third-quarter revenue – up 40% on a sequential basis.The oncology portfolio held steady in the third quarter, generating $1.7 billion in revenue, roughly flat year-over-year as gains in newer products offset weakness in older ones. Imbruvica sales were down nearly 15% to $706 million amid rising competition. Elahere, the company's antibody-drug conjugate (ADC) for ovarian cancer, climbed a little over 23% to $170 million, while newer lymphoma drug Epkinly was up around 59% to $69 million.Over the long term, Phipps said "we see potential from the company's Parkinson's disease franchise (Vyalev and tavapadon) as meaningful growth drivers and strong potential from the company's late-stage ADC portfolio (ABBV706 and ABBV400)."Meanwhile, AbbVie boosted its full-year profit outlook, now anticipating adjusted earnings of $10.61 to $10.65 per share, up from a range of $10.38 to $10.58 previously. Analysts project earnings of $10.51 per share and $60.7 billion in sales for the year.

ADCFinancial Statement

30 Oct 2025

·www.businesswire.com

Bicycle Therapeutics Reports Recent Business Progress and Third Quarter 2025 Financial Results

CAMBRIDGE, England & BOSTON--(BUSINESS WIRE)--Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported financial results for the third quarter ended September 30, 2025, and provided recent corporate updates. “We are currently seeking broad regulatory feedback to make an informed decision on our path forward with zelenectide pevedotin in metastatic urothelial cancer. We look forward to providing updates in the first quarter of 2026,” said Bicycle Therapeutics CEO Kevin Lee, Ph.D. “We have also been executing across the rest of our pipeline with the goal of helping patients live longer and live well. The development of zelenectide pevedotin for multiple Nectin-4 associated cancers is ongoing, with the Phase 1/2 Duravelo-3 trial for NECTIN4-amplified breast cancer and the Phase 1/2 Duravelo-4 trial for NECTIN4-amplified non-small cell lung cancer open and actively enrolling. Additionally, we were pleased to welcome additional esteemed global oncology leaders to the Bicycle Board of Directors and to our Research and Innovation Advisory Board to further strengthen our innovation and strategic growth.” Third Quarter 2025 and Recent Events Phase 2/3 Duravelo-2 pivotal trial evaluating zelenectide pevedotin in combination with pembrolizumab in patients with metastatic urothelial cancer (mUC). Bicycle Therapeutics is currently seeking regulatory feedback on zelenectide pevedotin, a Bicycle ® Drug Conjugate (BDC ® ). The company now expects to provide an update on dose selection for Duravelo-2 and zelenectide pevedotin’s potential approval pathway in mUC following meetings with multiple regulatory agencies in the first quarter of 2026. Data for an early Bicycle ® Radioconjugate (BRC ® ) molecule targeting MT1-MMP presented at European Association of Nuclear Medicine (EANM) 2025 Congress. An e-poster presentation outlined the first clinical experience with an early Bicycle Imaging Agent (BIA) targeting MT1-MMP. An additional e-poster presented by the German Cancer Consortium (DKTK), part of a cooperative network with the German Cancer Research Center (DKFZ), highlighted preclinical BRC data demonstrating the potential of this approach for radiotheranostic use. Altogether, the data build on preclinical and first human imaging data previously disclosed at the American Association for Cancer Research (AACR) Annual Meeting 2025 and EANM 2024. The company believes this data further supports the potential of MT1-MMP as a novel target in the treatment of cancer, demonstrates the translatability of BRC preclinical data and highlights the potential of Bicycle ® molecules for targeted radionuclide therapies and radiopharmaceutical imaging. The company continues to advance its emerging BRC pipeline, with initial EphA2 human imaging data expected in the first half of 2026 and the initiation of the first company-sponsored clinical trial expected in 2026. Trial in Progress data for Phase 1/2 Duravelo-3 trial for zelenectide pevedotin in NECTIN4-amplified breast cancer and tissue sample data in patients with NECTIN4-amplified non-small cell lung cancer (NSCLC) presented at the European Society for Medical Oncology (ESMO) Congress 2025. The Phase 1/2 Duravelo-3 trial for zelenectide pevedotin in NECTIN4-amplified breast cancer and the Phase 1/2 Duravelo-4 trial for zelenectide pevedotin in NECTIN4-amplified NSCLC are open and actively enrolling. Data from post-hoc analyses of late-line breast cancer and lung cancer patients enrolled in Duravelo-1 showed enhanced anti-tumor activity of zelenectide pevedotin in patients with NECTIN4 amplification and/or polysomy. Based on these data, the U.S. Food and Drug Administration (FDA) previously granted Fast Track designation to zelenectide pevedotin for the treatment of adult patients with previously treated, NECTIN4-amplified, advanced or metastatic triple-negative breast cancer and NSCLC. BT5528, a potential first-in-class EphA2 targeting BDC molecule. Phase 1 BT5528 combination data with nivolumab in mUC patients will now be presented at a scientific conference in the first half of 2026. BT7480, a Bicycle tumor-targeted immune cell agonist ® (Bicycle TICA ® ), is a Nectin-4 targeted CD137 agonist designed to overcome immune agonist toxicities and activate the immune system in Nectin-4 expressing tumors. Phase 1 BT7480 combination data with nivolumab will now be presented at scientific conference in the first half of 2026. Strengthened Board of Directors with the addition of Charles Swanton, M.D., Ph.D., FRS, FMedSci, FRCP, Roger Dansey, M.D. and Hervé Hoppenot. Dr. Swanton leads the Cancer Evolution and Genome Instability Laboratory at the Francis Crick Institute. Dr. Dansey currently serves on the Boards of Directors of Inovio Inc. and Ottimo Pharma. Mr. Hoppenot is an advisor to the CEO and serves on the Board of Directors of Incyte, after serving 11 years as its chairman and CEO. He is also Chairman of the Board of Directors of Maze Therapeutics. Expanded Research and Innovation Advisory Board (RAB) with the appointment of additional esteemed global leaders in oncology to further support scientific advancement and strategic growth across the company’s discovery research programs. The new RAB members are as follows: Steve Davidsen, Ph.D., is a biotech executive with over 35 years of experience in drug discovery and development. Dr. Davidsen currently serves as the founder and president of Predawn Discovery Advisors LLC, providing technical and strategic input to organizations engaged in therapeutic drug discovery. He also serves on the Scientific Advisory Boards of Nitrase Therapeutics and BioLoomics. Previously, Dr. Davidsen served as vice president, oncology discovery research at AbbVie, where he was responsible for discovery efforts across all of AbbVie’s oncology programs and sites. He held various positions of increasing responsibility at Abbott prior to the separation of AbbVie. Dr. Davidsen has directed research teams and partnerships leading to more than 40 first-in-human clinical trials across a broad range of platforms and biology targeting both hematologic and solid tumor indications. He has more than 70 scientific publications across a diverse range of topics including metalloproteinase inhibitors, kinase inhibitors and the discovery of histone deacetylase inhibitors. Dr. Davidsen earned a Ph.D. in organic chemistry from the University of Texas at Austin and a B.S. in chemistry from the University of Maryland. Gilles Gallant, B.Pharm, Ph.D., FOPQ, is an advisor and a consultant to biotechnology and pharmaceutical companies developing oncology drugs. He recently served as chief development officer at Mythic Therapeutics, responsible for the strategy, direction and execution of the company’s clinical development program. He also serves as a scientific advisor for Iteru Systems and is the founder and principal consultant of GG Biotech Consulting LLC. Previously, Dr. Gallant was senior vice president, global head of oncology clinical development at Daiichi Sankyo, leading the development of the company’s global oncology portfolio. At Daiichi, he led the clinical development and global approval of the antibody-drug conjugate (ADC) Enhertu ® (fam-trastuzumab deruxtecan-nxki) for the treatment of advanced breast cancer, gastric cancer and non-small cell lung cancer. Dr. Gallant also held leadership roles of increasing responsibility at Bristol-Myers-Squibb, Human Genome Sciences and BioMarin. Dr. Gallant earned a Ph.D. in medicinal chemistry and a B.Pharm from the Université de Montréal and is a Fellow of the Order of Pharmacists of Québec. Ken Herrmann, M.D., MBA, is a well-known leader in oncologic nuclear medicine with more than a decade of experience in clinical investigation. He currently serves on the Board of Directors of Aktis Oncology and as the chair of Aktis’ Scientific Advisory Board. Dr. Herrmann also serves as chair of the Department of Nuclear Medicine at the Universitätsklinikum Essen in Germany, member of Pentixapharm Holding AG’s Supervisory Board and associate editor of the Journal of Nuclear Medicine. Previously, he served as chair of the European Associates of Nuclear Medicine Oncology & Theranostics Committee, vice chair of the Department of Nuclear Medicine at the Universitätsklinikum Würzburg and associate professor in the Ahmanson Translational Imaging Division at the University of California, Los Angeles. To date, he has authored more than 700 peer-reviewed publications. Dr. Herrmann earned his M.D. from Humboldt Universität Berlin and his MBA from the Universität Zurich. John Lambert, Ph.D., is a recognized global leader in ADC discovery and development, currently serving as a consultant/advisor to biopharma and pharma on ADC technologies. He serves on the Avipep Therapeutics Board of Directors and is a scientific advisor to Cureteq AG, Synaffix BV, CytomX Therapeutics and Mythic Therapeutics, among other companies. Previously, Dr. Lambert was chief scientific officer and executive vice president of research at ImmunoGen. During his tenure in leadership roles there, ImmunoGen invented the ADC technology that resulted in Kadcyla ® (ado-trastuzumab emtansine) and Elahere ® (mirvetuximab soravtansine-gynx) for the treatment of HER2+ breast cancer and platinum-resistant ovarian cancers, respectively. He is a fellow of the American Institute for Medical and Biological Engineering and an honorary professor at Queen’s University Belfast. Dr. Lambert earned a Ph.D. in biochemistry from the University of Cambridge. Steve Davidsen, Ph.D., is a biotech executive with over 35 years of experience in drug discovery and development. Dr. Davidsen currently serves as the founder and president of Predawn Discovery Advisors LLC, providing technical and strategic input to organizations engaged in therapeutic drug discovery. He also serves on the Scientific Advisory Boards of Nitrase Therapeutics and BioLoomics. Previously, Dr. Davidsen served as vice president, oncology discovery research at AbbVie, where he was responsible for discovery efforts across all of AbbVie’s oncology programs and sites. He held various positions of increasing responsibility at Abbott prior to the separation of AbbVie. Dr. Davidsen has directed research teams and partnerships leading to more than 40 first-in-human clinical trials across a broad range of platforms and biology targeting both hematologic and solid tumor indications. He has more than 70 scientific publications across a diverse range of topics including metalloproteinase inhibitors, kinase inhibitors and the discovery of histone deacetylase inhibitors. Dr. Davidsen earned a Ph.D. in organic chemistry from the University of Texas at Austin and a B.S. in chemistry from the University of Maryland. Gilles Gallant, B.Pharm, Ph.D., FOPQ, is an advisor and a consultant to biotechnology and pharmaceutical companies developing oncology drugs. He recently served as chief development officer at Mythic Therapeutics, responsible for the strategy, direction and execution of the company’s clinical development program. He also serves as a scientific advisor for Iteru Systems and is the founder and principal consultant of GG Biotech Consulting LLC. Previously, Dr. Gallant was senior vice president, global head of oncology clinical development at Daiichi Sankyo, leading the development of the company’s global oncology portfolio. At Daiichi, he led the clinical development and global approval of the antibody-drug conjugate (ADC) Enhertu ® (fam-trastuzumab deruxtecan-nxki) for the treatment of advanced breast cancer, gastric cancer and non-small cell lung cancer. Dr. Gallant also held leadership roles of increasing responsibility at Bristol-Myers-Squibb, Human Genome Sciences and BioMarin. Dr. Gallant earned a Ph.D. in medicinal chemistry and a B.Pharm from the Université de Montréal and is a Fellow of the Order of Pharmacists of Québec. Ken Herrmann, M.D., MBA, is a well-known leader in oncologic nuclear medicine with more than a decade of experience in clinical investigation. He currently serves on the Board of Directors of Aktis Oncology and as the chair of Aktis’ Scientific Advisory Board. Dr. Herrmann also serves as chair of the Department of Nuclear Medicine at the Universitätsklinikum Essen in Germany, member of Pentixapharm Holding AG’s Supervisory Board and associate editor of the Journal of Nuclear Medicine. Previously, he served as chair of the European Associates of Nuclear Medicine Oncology & Theranostics Committee, vice chair of the Department of Nuclear Medicine at the Universitätsklinikum Würzburg and associate professor in the Ahmanson Translational Imaging Division at the University of California, Los Angeles. To date, he has authored more than 700 peer-reviewed publications. Dr. Herrmann earned his M.D. from Humboldt Universität Berlin and his MBA from the Universität Zurich. John Lambert, Ph.D., is a recognized global leader in ADC discovery and development, currently serving as a consultant/advisor to biopharma and pharma on ADC technologies. He serves on the Avipep Therapeutics Board of Directors and is a scientific advisor to Cureteq AG, Synaffix BV, CytomX Therapeutics and Mythic Therapeutics, among other companies. Previously, Dr. Lambert was chief scientific officer and executive vice president of research at ImmunoGen. During his tenure in leadership roles there, ImmunoGen invented the ADC technology that resulted in Kadcyla ® (ado-trastuzumab emtansine) and Elahere ® (mirvetuximab soravtansine-gynx) for the treatment of HER2+ breast cancer and platinum-resistant ovarian cancers, respectively. He is a fellow of the American Institute for Medical and Biological Engineering and an honorary professor at Queen’s University Belfast. Dr. Lambert earned a Ph.D. in biochemistry from the University of Cambridge. Participation in Upcoming Investor Conference Bicycle Therapeutics management will participate in the following investor conference in November: Jefferies Global Healthcare Conference in London on Tuesday, Nov. 18; fireside chat at 10:30 a.m. GMT A live webcast of the fireside chat will be accessible in the Investor section of the company’s website at www.bicycletherapeutics.com. An archived replay of the webcast will be available following the event. Third Quarter 2025 Financial Results Cash and cash equivalents were $648.3 million as of September 30, 2025, compared to $879.5 million as of December 31, 2024. The decrease in cash and cash equivalents is primarily due to cash used in operations, including increased cash payments for clinical program activities. In October 2025, we received $38.2 million related to our U.K. research and development (R&D) tax credit claim for the year ended December 31, 2024. R&D expenses were $58.4 million for the three months ended September 30, 2025, compared to $48.3 million for the three months ended September 30, 2024. The increase in expense of $10.1 million was primarily due to increased clinical program expenses for zelenectide pevedotin development, discovery, platform and other expenses, and higher personnel-related costs, including severance-related expenses of our workforce reduction in August 2025, offset by decreased clinical program expenses for Bicycle TICA ® molecules. General and administrative expenses were $18.9 million for the three months ended September 30, 2025, compared to $18.3 million for the three months ended September 30, 2024. The increase in expense of $0.6 million was primarily due to increased personnel-related costs, offset by decreased professional and consulting fees. Net loss was $59.1 million, or $(0.85) basic and diluted net loss per share, for the three months ended September 30, 2025, compared to net loss of $50.8 million, or $(0.74) basic and diluted net loss per share, for three months ended September 30, 2024. About Bicycle Therapeutics Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle® Drug Conjugate (BDC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BDC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radioconjugates (BRC®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass. For more information, visit bicycletherapeutics.com. Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the initiation of new clinical trials, the progress of Bicycle’s clinical trials, reporting data from Bicycle’s clinical trials, including for BT5528 and BT7480, the timing of EphA2 human imaging data and updates on dose selection in the Duravelo-2 clinical trial and accelerated approval pathway; the validation of MT1-MMP as a cancer target and BRC molecules having positive properties for radiopharmaceutical imaging; communications with and feedback from the FDA and other regulatory agencies; Bicycle’s expected financial runway; and the use of Bicycle Therapeutics’ technology through various partnerships to develop therapies for diseases beyond oncology. Bicycle Therapeutics may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in research and development and in the initiation, progress and completion of clinical trials and clinical development of Bicycle Therapeutics’ product candidates; the risk that Bicycle Therapeutics may not realize the intended benefits of its cost realignment efforts; the risk that Bicycle’s projections regarding its expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Bicycle Therapeutics’ actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in Bicycle Therapeutics’ Annual Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 8, 2025, as well as in other filings Bicycle Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle Therapeutics expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Bicycle Therapeutics plc Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share data) (Unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2025 2024 2025 2024 Collaboration revenue $ 11,734 $ 2,676 $ 24,631 $ 31,567 Operating expenses: Research and development 58,426 48,265 188,513 123,188 General and administrative 18,859 18,257 58,475 50,588 Total operating expenses 77,285 66,522 246,988 173,776 Loss from operations (65,551 ) (63,846 ) (222,357 ) (142,209 ) Other income (expense): Interest and other income 6,700 10,583 22,587 23,981 Interest expense (44 ) (33 ) (149 ) (1,678 ) Loss on extinguishment of debt — (954 ) — (954 ) Total other income, net 6,656 9,596 22,438 21,349 Net loss before income tax provision (58,895 ) (54,250 ) (199,919 ) (120,860 ) Provision for (benefit from) income taxes 205 (3,448 ) (1,113 ) (3,683 ) Net loss $ (59,100 ) $ (50,802 ) $ (198,806 ) $ (117,177 ) Net loss per share, basic and diluted $ (0.85 ) $ (0.74 ) $ (2.87 ) $ (2.15 ) Weighted average ordinary shares outstanding, basic and diluted 69,303,746 68,988,858 69,251,291 54,566,490 Balance Sheets Data (In thousands) (Unaudited) September 30, December 31, 2025 2024 Cash and cash equivalents $ 648,325 $ 879,520 Working capital 669,537 861,375 Total assets 763,954 956,868 Total shareholders’ equity 618,479 793,060

Phase 1Executive Change

100 Deals associated with Mirvetuximab soravtansine

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KEGG	Wiki	ATC	Drug Bank
D10954	Mirvetuximab soravtansine	-	DB12489

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Platinum-sensitive epithelial ovarian cancer	Canada	AbbVie, Inc.	01 Aug 2025
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.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	NDA/BLA	Canada	AbbVie, Inc.	01 Mar 2025
Platinum-Sensitive Fallopian Tube Carcinoma	Phase 3	United States	AbbVie, Inc.	27 Dec 2022
Platinum-Sensitive Fallopian Tube Carcinoma	Phase 3	China	AbbVie, Inc.	27 Dec 2022
Platinum-Sensitive Fallopian Tube Carcinoma	Phase 3	Japan	AbbVie, Inc.	27 Dec 2022
Platinum-Sensitive Fallopian Tube Carcinoma	Phase 3	Argentina	AbbVie, Inc.	27 Dec 2022
Platinum-Sensitive Fallopian Tube Carcinoma	Phase 3	Australia	AbbVie, Inc.	27 Dec 2022
Platinum-Sensitive Fallopian Tube Carcinoma	Phase 3	Belgium	AbbVie, Inc.	27 Dec 2022
Platinum-Sensitive Fallopian Tube Carcinoma	Phase 3	Brazil	AbbVie, Inc.	27 Dec 2022
Platinum-Sensitive Fallopian Tube Carcinoma	Phase 3	Bulgaria	AbbVie, Inc.	27 Dec 2022
Platinum-Sensitive Fallopian Tube Carcinoma	Phase 3	Canada	AbbVie, Inc.	27 Dec 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04209855 (MIRASOL, ESMO2025)	Phase 3	Folate receptor-alpha positive, platinumresistant epithelial ovarian cancer folate receptor alpha (FR⍺)-positive	453	Mirvetuximab soravtansine (MIRV)	bvumsljveh(ighmgudvtt) = erxpotavtc mbcdryaxvs (qggtwfaoqe, 4.3 - 5.9) View more	Positive	17 Oct 2025
				Investigator’s choice chemotherapy (ICC)	bvumsljveh(ighmgudvtt) = edzyltfwqw mbcdryaxvs (qggtwfaoqe, 2.9 - 4.5) View more
NCT05041257 (PICCOLO, ESMO_TAT Asia2025) Manual	Phase 2	Platinum-Sensitive Ovarian Carcinoma FRα-positive	38	Mirvetuximab soravtansine-gynx (MIRV) 6 mg/kg (HRD-positive)	eycznwtilx(rmfrptvzts) = rfouwkwfju rktmnkgliq (niyxsptibm ) View more	Positive	01 Jun 2025
				Mirvetuximab soravtansine-gynx (MIRV) 6 mg/kg (HRD-negative)	eycznwtilx(rmfrptvzts) = jatdddrxuc rktmnkgliq (niyxsptibm ) View more
NEWS \| Literature Manual	Not Applicable	Platinum-Resistant Ovarian Carcinoma	18	索米妥昔单抗	eqyytpdlld(tmvamhrtkx) = vpvptpvqnr qblskanwvv (rcdbyjtqgl ) 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)	xhkrpmnfjb(iteiplsiwq) = vmtvpqrrkm pvivtcydbp (elzouqpmlo, 4.34 - 5.88) View more	Positive	15 Mar 2025
				Chemotherapy	xhkrpmnfjb(iteiplsiwq) = wjsgebswhl pvivtcydbp (elzouqpmlo, 2.86 - 4.47) View more
NCT05041257 (PICCOLO, Pubmed \| Ann Oncol \| ESMO_TAT Asia2024 \| NEWS) Manual	Phase 2	Ovarian Cancer Third line FRα expression	79	Mirvetuximab Soravtansine	mqlpovqqqs(rpwtjuewvf) = vbouffwbzw bunqxwbhez (xdclzfqwzj, 40.4 - 63.3) Met View more	Positive	01 Nov 2024
				Mirvetuximab Soravtansine (PARPi naïve)	mqlpovqqqs(rpwtjuewvf) = qbmpjuddtt bunqxwbhez (xdclzfqwzj, 42.8 - 94.5) Met View more
SGO2024	Not Applicable	Toxicity high folate-receptor alpha expression (FOLR)	-	Mirvetuximab soravtansine	egsdkamrti(siaucofpgz) = 9 % experienced grade 3 ocular adverse reactions yzurowenus (reujpddpuq ) 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	tizbvnjfwv(tpstaowcye) = ezcqqxotdq mdnfwstqkj (bttaisuxmi, 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	syipnvdpnx(hvncdksrtn) = ldllpadlwp wntkrlkahr (obtvtswugk, 4.3 - 6.0) View more	Positive	14 Sep 2024
				Investigator’s choice chemotherapy (ICC): paclitaxel (PAC), pegylated liposomal doxorubicin (PLD), or topotecan (Topo)	syipnvdpnx(hvncdksrtn) = ywfrdwfimu wntkrlkahr (obtvtswugk, 2.9 - 4.5) View more
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	uykidziwyg = npuxrspmnb phtxatchsi (tadwnymjvg, hjvzrwazdi - zjnrvobxtv) View more	-	07 Aug 2024
NCT04296890 (SORAYA, Pubmed \| Int J Gynecol Cancer)	Phase 2	Platinum-Resistant Ovarian Carcinoma FRα-high	105	Mirvetuximab soravtansine-gynx	xvkvdvdyxg(thqmffulzp) = mmjpvxdqyh lutuivjboq (qapgpxelmt, 23.6 - 42.2) View more	Positive	01 Aug 2024
				Mirvetuximab soravtansine-gynx (one to two prior therapy lines)	xvkvdvdyxg(thqmffulzp) = sbxpmiczdi lutuivjboq (qapgpxelmt, 23.5 - 47.6) View more

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