Elahere (mirvetuximab soravtansine-gynx) / Huadong Medicine, Takeda, AbbVie - LARVOL DELTA

AbbVie Beats on Q2 Earnings & Sales, Stock Up on Raised '25 EPS View (Yahoo Finance) - "Sales from the oncology franchise rose 2.4% to $1.68 billion in the quarter....Sales of the breast cancer drug, Elahere, rose 23.7% to $159 million. However, the metric missed the Zacks Consensus Estimate of $184 million as well as our model estimate of $188 million. Epkinly sales, which comprise AbbVie’s share of profit from U.S. revenues and product revenues from international markets, amounted to $70 million in the quarter compared with $51 million in the previous quarter."

Sales • Diffuse Large B Cell Lymphoma • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Follicular Lymphoma • Peritoneal Cancer

Antibody-drug conjugates in gynecologic cancer: current landscape, clinical data, and emerging targets. (PubMed, Int J Gynecol Cancer) - "Currently, mirvetuximab soravtansine and tisotumab vedotin have been approved by the Food and Drug Administration for the treatment of folate receptor-alpha-positive, platinum-resistant ovarian cancer and recurrent cervical cancer, respectively, exhibiting promising objective response rates and manageable toxicity profiles in pivotal clinical trials...Additionally, multiple investigational ADCs, such as upifitamab rilsodotin (targeting NaPi2b), trastuzumab deruxtecan (targeting HER2), and sacituzumab govitecan (targeting trophoblast cell surface antigen 2), have demonstrated preliminary efficacy in ongoing clinical trials, offering new therapeutic opportunities for gynecologic malignancies. This review comprehensively summarizes the current clinical applications and research progress of ADCs in gynecologic cancers, including key clinical trials, therapeutic efficacy, safety profiles, and associated challenges. Furthermore, we discuss future optimization strategies,..."

Clinical data • Journal • Review • Cervical Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Pain • Solid Tumor • FOLR1 • HER-2 • SLC34A2

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. (PubMed, Gynecol Oncol) - "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."

Journal • Platinum resistant • Fallopian Tube Cancer • Fatigue • Oncology • Ovarian Cancer • Peritoneal Cancer • Pneumonia • Solid Tumor • FOLR1

Second Progression-Free Survival (PFS2) and Subsequent Treatment in Patients (pts) With Folate Receptor Alpha (FR⍺)-Positive Platinum-Resistant Ovarian Cancer (PROC) Treated With Mirvetuximab Soravtansine (MIRV) vs. Investigator's Choice Chemotherapy (ICC): Phase 3 MIRASOL Trial (ESMO 2025) - No abstract available

Clinical • P3 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Management of Advanced Ovarian Cancer: Current Clinical Practice and Future Perspectives. (PubMed, Biomedicines) - "The treatment landscape has evolved because bevacizumab and Poly-ADP Ribose Polymerase inhibitors now serve as frontline and maintenance therapies for homologous recombination-deficient tumors...The development of antibody-drug conjugates such as mirvetuximab soravtansine and immunotherapy, including checkpoint inhibitors and cancer vaccines, demonstrates promising investigative potential...The progress made in ovarian cancer treatment still faces challenges when it comes to drug resistance, survival improvement, and life quality preservation. The development of translational research alongside clinical trials remains essential to bridge treatment gaps while creating personalized therapies based on molecular and clinical tumor characteristics."

IO biomarker • Journal • Review • Epithelial Ovarian Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • HRD

HER2 status correlation with FRα expression in platinum-resistant advanced epithelial ovarian cancer, an initial single institution experience in the UK (BGCS 2025) - "The use of new targeted therapy mirvetuximab soravtansine on FRα-positive advanced ovarian high grade serous carcinoma (HGSC), is conditional in the UK... The initial test results show high FRα positivity in our cohort, which are all HER2 negative. It highlights the importance of FRα and HER2 testing for potential targeted therapy in advanced ovarian cancer."

Clinical • Metastases • Platinum resistant • Epithelial Ovarian Cancer • Gastric Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • BRCA • FOLR1 • HER-2

Final overall survival analysis among FRα-positive, platinum-resistant ovarian cancer patients treated with mirvetuximab soravtansine versus investigator's choice chemotherapy (MIRASOL) (BGCS 2025) - "MIRV treatment continued to demonstrate superior OS benefit compared to ICC with a 32% risk reduction of death, and a well -characterized safety profile."

Clinical • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • FOLR1 • PROC

Clinical pharmacologic considerations for antibody drug conjugates in gynecologic cancers. (PubMed, Expert Rev Clin Pharmacol) - "Information for this review article was obtained by literature review on PUBMED using phrases such as 'antibody drug conjugates in gynecologic cancers,' 'FDA approval for antibody drug conjugates in gynecologic cancers,' 'tisotumab vedotin,' 'mirvetuximab soravtansine,' 'trastuzumab deruxitcan,' 'sacituzumab govitecan,' 'datopotomab deruxtecan,' and 'sacituzumab tirumotecan.' ADCs represent a new frontier for the treatment of gynecologic malignancies. The few ADCs currently approved by the FDA for the treatment of gynecologic cancers demonstrated higher clinical activity and better tolerability when compared to standard investigator choice chemotherapy. Streamlined pathologic tissue testing of tumor samples is required for widespread use of ADCs, and future prospective studies are needed to ascertain whether ADCs can be introduced in first-line treatment for patients with advanced gynecologic malignancies."

Journal • Review • Gynecologic Cancers • Oncology

Mirvetuximab soravtansine approved to treat adult patients who have ovarian, fallopian tube or primary peritoneal cancer (GOV.UK) - "The Medicines and Healthcare products Regulatory Agency (MHRA) has...approved the medicine mirvetuximab soravtansine (Elahere) to treat adults with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. It is used in patients whose cancer cells have a protein on the surface known as folate receptor-alpha (FRα), and who have previously not responded to or are no longer responding to treatment with ‘platinum-based’ chemotherapy, and who have already received one to three prior treatments. Mirvetuximab soravtansine has been approved via the International Recognition Procedure (IRP)...This approval is supported by evidence from a study involving 453 adults with advanced platinum-resistant cancers of the ovary, fallopian tubes and the peritoneum that were FRα positive."

MHRA approval • Platinum resistant • Fallopian Tube Cancer • Ovarian Cancer • Peritoneal Cancer

Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Alessandro Santin | Trial primary completion date: Oct 2025 ➔ Oct 2026

Trial primary completion date • Endometrial Cancer • Endometrial Serous Adenocarcinoma • Oncology • Solid Tumor • FOLR1

IMGN853-0425: A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine (clinicaltrials.gov) - P2 | N=110 | Recruiting | Sponsor: AbbVie | Trial completion date: Feb 2029 ➔ Mar 2028 | Trial primary completion date: Jan 2029 ➔ Mar 2028

Adverse events • Platinum resistant • Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Hepatology • Oncology • Solid Tumor

FLORENZA: A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer (clinicaltrials.gov) - P2 | N=320 | Not yet recruiting | Sponsor: AbbVie

Adverse events • New P2 trial • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor

Update Gynecologic Malignancies 2025 - Expert Opinion on Systemic Therapy for Early and Advanced Gynecological Cancers. (PubMed, Geburtshilfe Frauenheilkd) - "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...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...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."

IO biomarker • Journal • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

GLORIOSA: Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer (clinicaltrials.gov) - P3 | N=520 | Recruiting | Sponsor: AbbVie | Trial primary completion date: Mar 2027 ➔ Apr 2029

Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • BRCA • FOLR1 • MUC16

Expression profiles of target genes for approved antibody-drug conjugates in the context of high-grade serous carcinoma (EACR 2025) - P=N/A | "Last year the first antibody-drug conjugate (ADC), Mirvetuximab soravtansine-gynx (Elahere), targeting FOLR1, was approved for platinum resistant ovarian cancer... Our analysis suggests that TACSTD2-targeting ADC could potentially be repurposed to HGSC. TACSTD2 demonstrated patterns of expression comparable to FOLR1 with potentially even wider patient group suitable for the treatment. The other genes studied here might be targetable in a few patients, but the decreased stability of their expression might pose a challenge for the clinical practice."

Oncology • Ovarian Cancer • Solid Tumor • CD22 • EGFR • FOLR1 • HER-2 • NECTIN4 • TACSTD2

Mirvetuximab Active in Platinum-Sensitive Ovarian Cancer Regardless of HRD Status (Targeted Oncology) - P2 | N=79 | PICCOLO (NCT05041257) | Sponsor: AbbVie | "Final data from the phase 2 PICCOLO trial (NCT05041257) demonstrated substantial efficacy in patients with folate receptor alpha (FRα)-positive recurrent platinum-sensitive ovarian cancer (PSOC) treated with mirvetuximab soravtansine-gynx (Elahere), regardless of homologous recombination deficiency (HRD) status)....These data, presented at the 2025 ESMO Gynecological Cancers Annual Congress, showed that at a median follow-up of 26.6 months, median progression-free survival (PFS) was 6.9 months (95% CI, 5.9-9.6) and median overall survival (OS) was 27.2 months (95% CI, 23.8 to not reached). In total, 79 patients received mirvetuximab soravtansine as third-line or greater treatment in patients with FRα-positive."

P2 data • Platinum sensitive • Ovarian Cancer

Oral cyclophosphamide in relapsed platinum-resistant ovarian cancer: A retrospective single-centre study at Mount Vernon cancer centre (ESMO-GC 2025) - "Mirvetuximab Soravtansine is a promising option for this population, however patients with a poor performance status will not be eligible. Given the manageable profile of adverse effects, it is a safe option for patients with poor performance status. Legal entity responsible for the study I. Reid."

Platinum resistant • Retrospective data • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

Mirvetuximab soravtansine exposure is associated with an increased incidence of cataract surgery in patients with ovarian cancer (ESMO-GC 2025) - "After using this tool/service, the author reviewed and edited the content as needed and take(s) full responsibility for the content of the publication. Legal entity responsible for the study The authors."

Clinical • Surgery • Oncology • Ovarian Cancer • Solid Tumor

Final analysis of the single-arm phase II PICCOLO trial of mirvetuximab soravtansine-gynx (MIRV) in folate receptor alpha (FRa)-positive, third-line and later (3L+), recurrent platinum-sensitive ovarian cancer (PSOC) (ESMO-GC 2025) - P2 | "This support was funded by AbbVie Inc. Legal entity responsible for the study AbbVie Inc."

P2 data • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Homologous recombination deficiency (HRD) and genomic subgroup analysis in patients (pts) with platinum-sensitive ovarian cancer (PSOC) receiving mirvetuximab soravtansine-gynx (MIRV) in the PICCOLO clinical trial (ESMO-GC 2025) - P2 | "Pts with HRD-positive and HRD-negative tumors had similar exposure to poly [ADP ribose] polymerase inhibitors (84% vs 79%) and bevacizumab (68% vs 63%); more pts with HRD-positive tumors had received >3 prior lines of therapy (11% vs 5%) and had a recent platinum-free interval of >12 months (63% vs 47%). This support was funded by AbbVie Inc. Legal entity responsible for the study AbbVie Inc."

Clinical • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor • FOLR1 • HRD

TAK-853-1501: A Study of TAK-853 in Adult Participants With Folate Receptor Alpha-Positive Advanced Ovarian Cancer And Other Solid Tumors (clinicaltrials.gov) - P1/2 | N=28 | Active, not recruiting | Sponsor: Takeda | Trial completion date: Sep 2026 ➔ Mar 2027 | Trial primary completion date: Sep 2025 ➔ Apr 2025

Trial completion date • Trial primary completion date • Oncology • Ovarian Cancer • Solid Tumor

State of the Art: Therapies Now and Around the Corner for Gynecologic Cancers. (PubMed, Am Soc Clin Oncol Educ Book) - "A prime example is the demonstrated benefit of mirvetuximab soravtansine over other standard chemotherapy options in folate receptor alpha-high platinum-resistant ovarian cancer. Maximizing such potential will require developing a deeper understanding of relationships between ADC target expression and activity, mechanisms of resistance, and potential approaches to sequencing. Beyond ADCs, additional therapies, including those targeting DNA damage response, remain in development."

IO biomarker • Journal • Platinum resistant • Review • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • BRCA • FOLR1

Mirvetuximab soravtansine for the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer. (PubMed, Future Oncol) - "Mirvetuximab soravtansine (MIRV) is FDA-approved for platinum-resistant ovarian cancer with high folate receptor alpha (FRα) expression. MIRV has also shown promising results in combination with bevacizumab and with carboplatin in platinum-sensitive disease. Ongoing research aims to optimize ADC components and explore synergistic combinations to expand MIRV's role in FRα-expressing ovarian cancer."

Journal • Platinum sensitive • Review • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ophthalmology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • FOLR1

IMGN853-0425: A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine (clinicaltrials.gov) - P2 | N=110 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting | Phase classification: P3 ➔ P2 | Trial completion date: Mar 2028 ➔ Feb 2029 | Initiation date: Feb 2025 ➔ May 2025 | Trial primary completion date: Mar 2028 ➔ Jan 2029

Adverse events • Enrollment open • Phase classification • Platinum resistant • Trial completion date • Trial initiation date • Trial primary completion date • Fallopian Tube Cancer • Hepatology • Oncology • Solid Tumor

Folate Receptor Alpha in Advanced Epithelial Ovarian Cancer: Diagnostic Role and Therapeutic Implications of a Clinically Validated Biomarker. (PubMed, Int J Mol Sci) - "An immunohistochemical (IHC) evaluation of FRα expression using the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay is now approved as a companion diagnostic for selecting patients eligible for mirvetuximab soravtansine, an FRα-targeted antibody-drug conjugate...We also discuss heterogeneity in FRα expression across histological subtypes and tumor sites, as well as the impact of archival versus fresh tissue. Understanding FRα expression patterns across histologic subtypes and tissue samples is critical for optimizing clinical decision-making and expanding the role of FRα-targeted therapies in gynecologic oncology."

Biomarker • Journal • Review • Epithelial Ovarian Cancer • Gynecologic Cancers • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • FOLR1