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

IMPROVED PROGRESSION-FREE SURVIVAL WITH COMBINATION BEVACIZUMAB AND MIRVETUXIMAB SORAVTANSINE-GYNX IN PLATINUM-RESISTANT OVARIAN CANCER (IGCS 2025) - No abstract available

Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer. (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Enrollment open • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Corneal events with mirvetuximab soravtansine : A review of ocular surface events associated with the tubulin-acting antibody-drug conjugate, mirvetuximab soravtansine (PubMed, Ophthalmologie) - "Ocular adverse events (AEs) are common among ADCs with tubulin-targeted active agents, such as belantamab mafodotin, tisotumab vedotin and mirvetuximab soravtansine (MIRV). Support from ophthalmologists is essential to AE management to allow MIRV therapy to continue. This review provides ophthalmologists with a clinical overview of ocular AEs associated with certain tubulin-acting ADCs, with a focus on MIRV, and the prophylactic/mitigative measures that can allow patients to stay on MIRV therapy longer."

Journal • Review • Oncology • Ophthalmology • Ovarian Cancer • Solid Tumor • FOLR1

Folate receptor alpha (FRα/FOLR1) and HER2 immunohistochemical staining in high-grade endometrial carcinoma with aberrant p53 expression. (PubMed, Histopathology) - "A positive correlation between HER2 and FOLR1 overexpression may be seen in high-grade endometrial carcinomas with aberrant p53 expression, which may extend to intratumoral heterogeneity of biomarker expression."

Journal • P53mut • Endometrial Cancer • Oncology • Peritoneal Cancer • Solid Tumor • FOLR1 • HER-2 • TP53

Management of ocular toxicity in patients with gynecologic cancer receiving novel antibody-drug conjugates: a narrative review. (PubMed, Clin Transl Oncol) - "Agents such as mirvetuximab soravtansine, and tisotumab vedotin, targeting folate receptor alpha and tissue factor, respectively, reported clinical efficacy in patients with limited options. Comprehensive management of ocular toxicities is essential to ensure the safe and sustained use of ADCs, preserving both therapeutic benefit and patient well-being. Further research is warranted to optimize preventive and management protocols."

Journal • Review • Cervical Cancer • Dry Eye Disease • Gynecologic Cancers • Herpes Zoster • Oncology • Ophthalmology • Ovarian Cancer • Varicella Zoster • FOLR1

Mirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Folate Receptor Alpha (FRα) Expressing, Platinum-sensitive Epithelial Ovarian Cancer (clinicaltrials.gov) - P2 | N=125 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: May 2026 ➔ Nov 2026 | Trial primary completion date: May 2026 ➔ Nov 2026

Platinum sensitive • Trial completion date • Trial primary completion date • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • BRCA • FOLR1

Mirvetuximab soravtansine in the ovarian cancer treatment landscape: influence of prior taxane exposure on outcomes. (PubMed, Int J Gynecol Cancer) - "Real-world experience with mirvetuximab demonstrated a favorable safety profile and clinical benefit in platinum-resistant ovarian cancer. Taxane therapy immediately preceding mirvetuximab was associated with shorter overall survival but not increased neurotoxicity."

Journal • Platinum resistant • Hematological Disorders • Oncology • Ovarian Cancer • Pain • 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

Health Canada Approves ELAHERE for Certain Types of Platinum-Resistant Ovarian Cancers (Canada Newswire) - "...based on data from the pivotal MIRASOL Phase 3 trial, establishing it as a potential new standard of care for folate receptor alpha (FRα)-positive PROC)."

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

Comprehensive Review of the Ocular Toxicities Associated With Antibody-Drug Conjugates Used to Treat Gynecological Cancers. (PubMed, Cureus) - "Currently, mirvetuximab soravtansine (MIRV) and tisotumab vedotin (TV) are Food and Drug Administration (FDA)-approved ADCs used in the treatment of gynecological cancers, demonstrating efficacy in clinical trials...When combined with bevacizumab and carboplatin, these drugs are associated with increased ocular adverse events...In addition, a standardized reporting system is recommended to facilitate this process. We therefore aim to provide a thorough understanding of ocular toxicities in ADCs, with the objective of optimizing patient care within the field of gynecological oncology and contributing to the improvement of patient outcomes."

Journal • Review • Cervical Cancer • Conjunctivitis • Gynecologic Cancers • Ocular Infections • Ocular Inflammation • Oncology • Ophthalmology

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

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

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

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

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