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

Efficacy and safety of mirvetuximab soravtansine in platinum-resistant recurrent ovarian cancer beyond third-line therapy: A retrospective real-world Chinese study (ESMO Asia 2025) - "The cohort (n=47) demonstrated mean age 55.8 years, median treatment lines 4.0, BMI 23.3 kg/m2, and prior bevacizumab administrations 12.5. MIRV demonstrated clinically meaningful activity and manageable toxicity in real-world. NACT history and obesity emerged as risk factors for treatment failure."

Platinum resistant • Real-world • Real-world evidence • Retrospective data • Oncology • Ovarian Cancer • Solid Tumor • FOLR1 • MUC16

Therapeutic Applications and Target Strategies of Antibody-Drug Conjugates in Ovarian Cancer. (PubMed, Iran J Pharm Res) - "This review summarizes a range of ADCs targeting tumor-associated antigens in ovarian cancer, including mirvetuximab soravtansine (MIRV), trastuzumab deruxtecan (T-DXd), datopotamab deruxtecan (Dato-DXd), sacituzumab tirumotecan (SKB-264), PF-06664178, anetumab ravtansine (BAY 94-9343), BMS-986148, DMOT4039A, RC88, lifastuzumab vedotin (DNIB0600A), upifitamab rilsodotin (ABBV-181), ZW220, DMUC4064A, and sofituzumab vedotin (DMUC5754A). The ADCs hold significant potential to reshape the treatment landscape for ovarian cancer by providing targeted therapeutic options. Further research is required to optimize patient selection, address resistance mechanisms, and improve safety profiles."

Journal • Review • Oncology • Ovarian Cancer • Solid Tumor • MUC4

A case report of total epidermal necrosis following mirvetuximab soravtansine extravasation. (PubMed, Gynecol Oncol Rep) - "Central venous access and standardized documentation may mitigate risk. Increased awareness and reporting are needed to inform clinical guidelines and ensure safe administration of ADC therapies."

Journal • Oncology • Ovarian Cancer • Solid Tumor

Results of the First Folate Receptor Alpha Testing Trial by the German Quality Assurance Initiative in Pathology (QuIP®). (PubMed, Cancers (Basel)) - "Mirvetuximab soravtansine-gynx, an FRα-targeting ADC, has been approved by the FDA and EMA for the treatment of FRα-positive, platinum-resistant ovarian cancer... These findings highlight the critical importance of standardized, validated assays for FRα detection to ensure accurate patient selection for targeted therapies. The study emphasizes the need for further optimization of alternative antibodies before clinical implementation."

Journal • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Heterogeneity and Scoring Reproducibility of Folate Receptor 1 Immunohistochemistry in High-grade Serous Carcinoma. (PubMed, Int J Gynecol Pathol) - "Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate approved for the treatment of adult patients with folate receptor 1 (FRα; FOLR1) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens...Our study highlights several factors contributing to heterogeneity in FOLR1 reporting. Future studies are needed to better understand the impact of FOLR1 heterogeneity on patient response to therapy."

Heterogeneity • Journal • Platinum resistant • Fallopian Tube Cancer • High Grade Serous Ovarian Cancer • Oncology • Peritoneal Cancer • Solid Tumor • FOLR1

The efficacy and safety of mirvetuximab soravtansine for the treatment of recurrent ovarian cancer: an update systematic review and meta-analysis. (PubMed, Discov Oncol) - "MIRV demonstrates significant efficacy and an acceptable safety profile in the treatment of recurrent ovarian cancer. Its use in platinum-resistant ovarian cancer with high FRα expression represents a particularly promising Therapeutic approach. Furthermore, the combination of MIRV and bevacizumab shows substantial potential for improving outcomes in patients with platinum-resistant disease."

Journal • Platinum resistant • Retrospective data • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Development and application of antibody-drug conjugates in gynecological cancers. (PubMed, Sci China Life Sci) - "Their clinical applications and associated challenges have also been highlighted. Finally, we discuss the prospects of ADCs in the treatment of gynecological cancers."

Journal • Review • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • Women's Health

FRAmework-01: A Two-Part Phase 3 Study of LY4170156 in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer (clinicaltrials.gov) - P3 | N=1080 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Platinum resistant • Platinum sensitive • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor

Real-World Treatment Patterns of US Patients With Platinum-Resistant Ovarian Cancer (ISPOR-EU 2025) - "For index PROC treatment, 37.0% received single-agent non-platinum chemotherapy, 32.2% received bevacizumab-containing regimen, 14.7% received platinum-based therapy, 3.9% received mirvetuximab soravtansine (MIRV),12.3% received other regimens. In advanced ovarian cancer, treatment options are limited following platinum resistance, with some patients continuing to receive platinum despite limited benefit. TTNT and TTD are short for patients with PROC, highlighting the unmet need in this population."

Clinical • HEOR • Platinum resistant • Real-world • Real-world evidence • Oncology • Ovarian Cancer • 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 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • Oncology • Ovarian Cancer • Solid Tumor

MC003: ADoTope, a first-in-class dual-payload bi-epitope combination chemoimmunotherapy antibody drug conjugate (ADC) targeting folate receptor alpha in platinum-resistant epithelial ovarian cancer (SITC 2025) - "While the FDA has approved mirvetuximab soravtansine for platinum-resistant ovarian cancer, its clinical performance underscores a persistent unmet need in this highly refractory population. Our data provides preclinical support for the ADoTope platform and justifies advancing MC003 to further development for platinum-resistant ovarian cancer treatment. MC003 is currently in IND-enabling stage of development.Ethics Approval All animal experiments were carried out under the Sanyou Biopharmaceuticals Laboratory Animal Ethics Committee.Abstract 995 Figure 1Request permissions"

IO biomarker • Platinum resistant • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

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 | Not yet recruiting | Sponsor: AbbVie | Trial completion date: Oct 2029 ➔ Feb 2030 | Initiation date: Aug 2025 ➔ Nov 2025

Trial completion date • Trial initiation date • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

GenSci140: A potential best-in-class biparatopic FRα-targeting ADC with broadened patient coverage in ovarian and other cancers (ESMO 2025) - "While IMGN853/ELAHERE TM , a FRα-targeting ADC, has been approved for platinum-resistant epithelial ovarian cancer (PROC) patients with high FRα expression, only limited activity was observed in the lower FRα-expressing populations...Combination of GenSci140 and Keytruda demonstrated synergistic effects in CDX model...Legal entity responsible for the study Changchun GeneScience Pharmaceutical Co., Ltd. Funding Changchun GeneScience Pharmaceutical Co., Ltd."

Clinical • Endometrial Cancer • Epithelial Ovarian Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • FOLR1

Antibody-Drug Conjugates for the Treatment of Gynecologic Cancer: A Review of the Current Evidence and Clinical Application. (PubMed, Hematol Oncol Clin North Am) - "Two of these drugs are currently approved for treatment of gynecologic cancers and many more are under investigation. Along with the expected toxicities associated with chemotherapy drugs, antibody-drug conjugates can cause more atypical adverse events; the treating oncologist should be aware of these toxicities and their management."

Journal • Review • Cervical Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

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. (PRNewswire) - "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."

Sales • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Fallopian Tube Cancer • Mantle Cell Lymphoma • Ovarian Cancer • Peritoneal Cancer • Waldenstrom Macroglobulinemia

An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib (clinicaltrials.gov) - P2 | N=53 | Recruiting | Sponsor: University of Colorado, Denver | Trial completion date: Dec 2027 ➔ Oct 2028 | Trial primary completion date: Apr 2026 ➔ Jan 2028

Platinum sensitive • Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • BRCA

Open label, multicenter, phase 2 study of farletuzumab ecteribulin (FZEC), a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), alone and in combination with lenvatinib in platinum-resistant ovarian cancer (PROC) (AACR-NCI-EORTC 2025) - P1/2 | "Up to 3 prior lines of systemic therapy are allowed; up to 4 prior lines of therapy are permitted for patients who received prior mirvetuximab soravtansine. Previous bevacizumab maintenance therapy is permitted and is not counted as an independent line of therapy...Adverse events will be monitored and graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0; interstitial lung disease events will be carefully monitored and managed. This multinational study is actively recruiting."

Clinical • Combination therapy • Late-breaking abstract • P2 data • Platinum resistant • Fallopian Tube Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • CTSB • FOLR1

NAPISTAR 1-01: A phase I dose escalation study of TUB-040, a novel NaPi2b-targeting exatecan antibody-drug conjugate (ADC) in patients with platinum-resistant ovarian (PROC) high grade serous carcinoma (HGSC) (ESMO 2025) - P1/2 | "Pts had a median age of 62 y (range 34-81), ECOG PS 0 or 1, a median of 4 prior lines of therapy (range 1-7); prior treatment included bevacizumab (84%), PARP inhibitors (76%) and mirvetuximab soravtansine (13%). 1 Values reported with 95% CI. Conclusions TUB-040 was well tolerated with robust clinical activity even at low doses, offering a differentiated potential new option for treatment with a highly favorable benefit–risk profile."

Clinical • Late-breaking abstract • P1 data • Platinum resistant • Lung Cancer • Non Small Cell Lung Cancer • Oncology • MUC16 • SLC34A2

Current progress and latest therapeutic options in immuno-oncology (PubMed, Dtsch Med Wochenschr) - "For solid cancers, these comprise the antibody-drug-conjugate Mirvetuximab Soravtansine for platinum-resistant ovarian cancer, the monoclonal antibody Zolbetuximab for Claudin-18.2 positive gastric adenocarcinoma and the checkpoint inhibitor Tislelizumab for esophageal squamous cell carcinoma. For the treatment of relapsed or refractory hematologic B cell malignancies, the use of bispecific T cell engaging antibodies like the BCMA-CD3 targeting Teclistamab and CD20-CD3 targeting Glofitamab were approved by the EMA recently.Combinatorial approaches of conventional chemotherapy and checkpoint inhibitors for the treatment of cholangiocarcinoma, urothelial carcinoma and endometrial carcinoma received recent approval.A CD38 antibody-based bridging therapy for the treatment of newly diagnosed multiple myeloma and the Glofitamab-based approach in combination with Gemcitabine and Oxaliplatin for relapsed DLBCL are the latest additions for hematologic malignancies after promising..."

Journal • Review • Biliary Cancer • Cholangiocarcinoma • Diffuse Large B Cell Lymphoma • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Adenocarcinoma • Gastric Cancer • Hematological Disorders • Hematological Malignancies • Melanoma • Multiple Myeloma • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Synovial Sarcoma • Urothelial Cancer • CLDN18

IMPROVED PROGRESSION-FREE SURVIVAL WITH COMBINATION BEVACIZUMAB AND MIRVETUXIMAB SORAVTANSINE-GYNX IN PLATINUM-RESISTANT OVARIAN CANCER (IGCS 2025) - "Of 56 patients planned to receive MIRV, 51 were evaluable. Patients received a median of three prior lines of therapy, with 86.3% having had prior bevacizumab. Notably, 39.2% of patients got MIRV in combination with bevacizumab."

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

PART C OF RAINFOL™-01: A PHASE 1/2 STUDY OF SINGLE-AGENT RINATABART SESUTECAN IN PATIENTS WITH ADVANCED AND/OR METASTATIC PLATINUM-RESISTANT OVARIAN CANCER (IGCS 2025) - P1/2 | "Prior therapies can include bevacizumab, PARP inhibitors, or mirvetuximab soravtansine (Table). Current Status & Future Directions: Part C is currently enrolling. Study outcomes may provide further insights on whether Rina-S could be a safe and efficacious treatment for patients with PROC."

Clinical • Metastases • P1/2 data • Platinum resistant • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • FOLR1 • MUC16

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 III MIRASOL trial (ESMO 2025) - P3 | "In the ITT, 152/227 (67%) MIRV pts vs 147/226 (65%) ICC pts went on to receive a new anticancer therapy, including, most commonly, taxanes (35% vs 26%), gemcitabine (24% vs 26%), platinum-based compounds (19% each), bevacizumab (19% vs 16%), and anthracyclines (25% vs 9%); 2 (<1%) vs 16 (7%) pts received MIRV. Conclusions MIRV demonstrated favorable PFS2 vs ICC irrespective of prior PARPi or bevacizumab exposure. These results further strengthen MIRV as the standard of care with durable clinical benefit continuing beyond progression."

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

MAESTRA 1: A phase II, single-arm study of INCB123667 in patients with platinum-resistant ovarian cancer (PROC) with cyclin E1 (CCNE1) overexpression (ESMO 2025) - "PROC standard treatment is mirvetuximab soravtansine (mirv) for pts with folate receptor α (FRα)-positive PROC or non-platinum chemotherapy +/- bevacizumab (bev). Secondary endpoints include safety and tolerability, duration of response, progression-free survival and overall survival. Table: 1220TiP Study cohorts Cohort Cyclin E1 expression levels 1 (n≈100) ≥75% tumor cells with ≥1+ staining intensity 2 (n≈30) ≥50% to <75% tumor cells with ≥1+ staining intensity 3 (n≈30) <50% tumor cells with ≥1+ staining intensity"

Clinical • P2 data • Platinum resistant • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • CCNE1 • FOLR1

Seminal Abstract: SECOND PROGRESSION-FREE SURVIVAL (PFS2) AND SUBSEQUENT TREATMENT IN PATIENTS (PTS) WITH FOLATE RECEPTOR ALPHA (FRΑ)-POSITIVE PLATINUM-RESISTANT OVARIAN CANCER (PROC) TREATED WITH MIRVETUXIMAB SORAVTANSINE (MIRV) VS. INVESTIGATOR'S CHOICE CHEMOTHERAPY (ICC): PHASE 3 MIRASOL TRIAL (IGCS 2025) - "In the ITT, 152/227 (67%) MIRV pts vs 147/226 (65%) ICC pts went on to receive a new anticancer therapy, including, most commonly, taxanes (35% vs 26%), gemcitabine (24% vs 26%), platinum-based compounds (19% each), bevacizumab (19% vs 16%), and anthracyclines (25% vs 9%); 2 (<1%) vs 16 (7%) pts received MIRV. MIRV demonstrated favorable PFS2 vs ICC irrespective of prior PARPi or bevacizumab exposure. These results further strengthen MIRV as the standard of care with durable clinical benefit continuing beyond progression. Previously presented at the European Society for Medical Oncology 2025 Congress, FPN (Final Publication Number): 1068P, Kathleen Moore et al."

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

TREVI-OC-01: AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer (clinicaltrials.gov) - P3 | N=1100 | Not yet recruiting | Sponsor: AstraZeneca

New P3 trial • Platinum resistant • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor