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

Results from the first-in-human phase I study of LY4170156, an antibody drug conjugate (ADC) targeting folate receptor alpha in recurrent platinum resistant high-grade serous ovarian cancer (HGSOC) (ESMO 2025) - P1 | "LY4170156 demonstrated preclinical in vivo efficacy across all FRα expression levels and mirvetuximab soravtansine-gynx (mirv) resistant ovarian models, as well as across multiple tumor types. Conclusions LY4170156 was well-tolerated among PROC pts with promising clinical activity across all FRα expression levels and regardless of prior mirv treatment. Updated results from the PROC dose optimization cohort (n=61) and efficacy among all FRα expression levels will be presented."

First-in-human • P1 data • Platinum resistant • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

A DualSurface ADAPT Scaffold Protein Enables Selective and Specific Targeting of Folate ReceptorAlpha with Simultaneous HalfLife Extension (EANM 2026) - "While FRatargeting antibody-drug conjugate mirvetuximab soravtansine reached clinical use, small scaffold proteins remain insufficiently explored due to their rapid renal clearance... This study demonstrates the feasibility of FRa targeting using a novel dualsurface ADAPT scaffold protein, integrating tumor targeting and halflife extension within one of the smallest engineered affinity proteins reported to date. The favorable pharmacokinetics, reduced renal retention, and FRaspecific tumor uptake make ADAPT22 as a promising platform for FRatargeted delivery of therapeutic payloads, such as cytotoxic drugs for targeted therapy."

Ovarian Cancer • Solid Tumor • FOLR1

Update on ovarian cancer (PubMed, Pathologie (Heidelb)) - "A milestone in the systemic treatment of advanced ovarian cancer is the option of maintenance therapy with bevacizumab, poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitors, or the combination of olaparib plus bevacizumab...If platinum is not an option, three phase III trials have fortunately now demonstrated a significant overall survival benefit with the antibody-drug conjugate (ADC) mirvetuximab soravtansine (MIRV) in patients with high α‑folate receptor expression (MIRASOL trial), or with pembrolizumab plus paclitaxel ± bevacizumab in patients with CPS ≥ 1 (KEYNOTE-B96 trial), as well as with relacorilant plus nab-paclitaxel (ROSELLA trial), each compared to standard chemotherapy. MIRV and Pembrolizumab are already approved. The increasingly complex treatment of ovarian cancer should therefore be carried out in specialized German Cancer Society (DKG)-certified gynecological cancer centers as an effective tool for quality..."

Journal • Review • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • BRCA • HRD

SOFETABART MIPITECAN, A FOLATE RECEPTOR ALPHA-TARGETED ANTIBODY-DRUG CONJUGATE IN FRΑ-HIGH, MIRVETUXIMAB SORAVTANSINE-NAÏVE PLATINUM-RESISTANT OVARIAN CANCER; RESULTS FROM A PHASE 1 STUDY (IGCS 2026) - P1, P3 | "Fifty-four FRα-high, MIRV-naïve PROC patients received Sofe-M at 2 mg/kg (n=15), 3mg/kg (n=3), 4mg/kg (n=34), and 6mg/kg (n=2). Median age was 64years (range, 37–89). Median prior therapies: 4 (range, 1-9)."

ADC • P1 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Results from the first-in-human phase 1 study of LY4170156, a folate receptor alpha-targeting antibody drug conjugate, in ovarian cancer patients previously exposed to antibody drug conjugate therapy (ESGO 2026) - "Mirvetuximab soravtansine-gynx (MIRV) improved clinical outcomes in platinum-resistant ovarian cancer (PROC) with high FRα expression. Conclusion LY4170156 demonstrated encouraging clinical activity and was well-tolerated in prior ADC-exposed PROC patients. Comparable responses to the whole population were observed in MIRV and other ADC-exposed patients, supporting the efficacy and broad therapeutic utility of LY4170156 in PROC."

Clinical • First-in-human • P1 data • Oncology • Ovarian Cancer • Solid Tumor • FOLR1 • PROC • TOP1

FLORENZA: A phase 2, open-label, randomized study to evaluate safety, efficacy, and dose optimization of mirvetuximab soravtansine (MIRV) combination therapies for epithelial ovarian cancer (EOC) (ESMO 2026) - No abstract available

Clinical • Combination therapy • P2 data • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

Time to improvement in fatigue patient-reported outcomes (PRO) with mirvetuximab soravtansine (MIRV) vs investigator-choice chemotherapy (ICC) in platinum-resistant ovarian cancer (PROC) (ESMO 2026) - No abstract available

Clinical • Patient reported outcomes • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

Hematologic safety of carboplatin (Carbo) plus mirvetuximab soravtansine (MIRV) in patients (pts) with folate receptor alpha (FRα)-expressing platinum-sensitive ovarian cancer (PSOC) (ESMO 2026) - No abstract available

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

Pretreatment albumin levels as a predictor of mirvetuximab soravtansine effectiveness in platinum-resistant ovarian cancer (PROC) patients (ESMO 2026) - No abstract available

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

Assessment of mirvetuximab soravtansine (MIRV) vs investigator's choice chemotherapy (ICC) as first line of therapy in folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) in MIRASOL (GOG 3045/ENGOT-ov55) (ESMO 2026) - No abstract available

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

A randomized phase II trial of mirvetuximab soravtansine in folate receptor alpha (FRα)–high recurrent ovarian cancer eligible for platinum-based chemotherapy (MIROVA/AGO-OVAR 2.34). (ASCO 2026) - P2 | " Randomized phase II trial comparing 6 cycles of carboplatin AUC5+MIRV 6 mg/kg AIBW every 3 weeks followed by MIRV versus 6 cycles of carboplatin combined with either paclitaxel, gemcitabine or pegylated liposomal doxorubicin followed by maintenance PARP inhibitor (PARPi) if applicable...Of them, 112/145 (77.2%) patients had received prior bevacizumab and 97/145 (66.9%) had prior PARPi, 15.2% were BRCAmut... MIROVA/AGO-OVAR 2.34 is the first randomized trial evaluating the activity and safety of the combination of carboplatin with an antibody-drug conjugate in the setting of platinum-eligible relapsed ovarian cancer. The primary endpoint regarding improvement of PFS was not met. Further analysis will be presented."

Clinical • P2 data • Oncology • Ovarian Cancer • Solid Tumor • BRCA • 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

A randomized phase II trial of mirvetuximab soravtansine, in folate receptor alpha (FR?) high recurrent ovarian cancer eligible for platinum-based chemotherapy (MIROVA/AGO-OVAR 2.34) (ESMO-Gynae 2026) - P2 | "Methods Randomized phase II trial comparing 6 cycles of carboplatin combined with either paclitaxel, gemcitabine or pegylated liposomal doxorubicin followed by maintenance PARP inhibitor (PARPi) if applicable (arm A) versus 6 cycles of carboplatin AUC5+MIRV 6 mg/kg AIBW every 3 weeks followed by MIRV (arm B)...Of them, 112/145 (77.2%) patients had received prior bevacizumab and 97/145 (66.9%) had prior PARPi, 14.5% were BRCAmut...The combination of carboplatin/mirvetuximab soravtansine is feasible and shows high response rates, but this did not result in a longer median PFS, which was the primary endpoint. No new safety signals have been observed."

Clinical • P2 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • BRCA • FOLR1

Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer. (PubMed, N Engl J Med) - P3 | "Among participants with platinum-resistant, FRα-positive ovarian cancer, treatment with MIRV showed a significant benefit over chemotherapy with respect to progression-free and overall survival and objective response. (Funded by ImmunoGen; MIRASOL ClinicalTrials.gov number, NCT04209855.)."

Journal • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • FOLR1

Efficacy and Safety of Mirvetuximab Soravtansine in Patients With Platinum-Resistant Ovarian Cancer With High Folate Receptor Alpha Expression: Results From the SORAYA Study. (PubMed, J Clin Oncol) - "MIRV demonstrated consistent clinically meaningful antitumor activity and favorable tolerability and safety in patients with FRα-high PROC who had received up to three prior therapies, including bevacizumab, representing an important advance for this biomarker-selected population."

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

DYNAMIC CHANGES IN FOLR1 EXPRESSION DURING PLATINUM/TAXANE AND MIRVETUXIMAB SORAVTANSINE THERAPY IN OVARIAN CANCER (IGCS 2026) - "In cohort -1, patients received first -line platinum+taxane (without bevacizumab) and had paired pre -/on-treatment samples(n=20) or paired pre -/post- treatment sa mples(n=22). MIRV therapy was associated with a significant decrease in FOLR1- expression(p=0.006) with a large effect size(Cohen's d=−1.46). Following platinum+taxane chemotherapy, FOLR1-expression was decreased in 15/20(75%) on -treatment samples(p=0.036). In contrast, no significant difference was observed between pre-/post-treatment samples(p=0.75), indicating chemotherapy -associated suppression was not sustained after treatment complet ion or progression."

Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Safety and efficacy results in patients who received dose modifications in the phase III MIRASOL (GOG 3045/ENGOT-ov55) trial of mirvetuximab soravtansine vs investigator's choice chemotherapy (ICC) in platinum-resistant ovarian cancer (PROC) with high folate receptor-alpha expression (ESMO-GC 2024) - " 453 PROC pts with high FRα expression (VENTANA FOLR1 [FOLR1-2.1] RxDx Assay) with 1-3 prior therapies were randomized 1:1 to MIRV 6 mg/kg, adjusted ideal body weight, Day 1 of a 21-day cycle or ICC: paclitaxel, pegylated liposomal doxorubicin, or topotecan...In the MIRV arm, 36% had prior bevacizumab vs. 45% in the ICC arm, and 55% had prior PARPi vs 59% in the ICC... Dose modifications occurred at similar rates in both treatment arms. MIRV demonstrated a longer PFS, OS, and higher ORR vs ICC in patients with dose modifications. The efficacy data and the well-characterized safety profile support MIRV as the standard of care for pts with FRα positive PROC."

Clinical • P3 data • Gastrointestinal Disorder • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Mirvetuximab soravtansine in folate receptor alpha (FRα)-high platinum-resistant ovarian cancer: final overall survival and post hoc sequence of therapy subgroup results from the SORAYA trial. (PubMed, Int J Gynecol Cancer) - P3 | "These results support the clinically meaningful efficacy of mirvetuximab soravtansine-gynx in FRα-expressing platinum-resistant ovarian cancer, irrespective of prior treatment or sequence."

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

Phase III MIRASOL (GOG 3045/ENGOT-ov55) study: Initial report of mirvetuximab soravtansine vs. investigator's choice of chemotherapy in platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. (ASCO 2023) - P3 | " 453 PROC pts with high FRα expression (Roche FOLR1 Assay) with 1-3 priors were randomized 1:1 to MIRV 6 mg/kg, adjusted ideal body weight, Day 1 of a 21-day cycle or IC: paclitaxel, pegylated liposomal doxorubicin, or topotecan. MIRV is the first treatment to demonstrate a PFS and OS benefit in PROC compared to IC. The efficacy data, along with the well-characterized safety profile, position MIRV as a new, standard of care for pts with FRα positive PROC. Clinical trial information: NCT04209855."

Late-breaking abstract • Metastases • P3 data • Fallopian Tube Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor • FOLR1

ASCO Issues First Living Guideline for Recurrent Ovarian Cancer Treatment:…What does the guideline recommend for platinum-resistant recurrence? (Cancer Network) - "For platinum-resistant or platinum-refractory ovarian cancer, the panel strongly recommends mirvetuximab soravtansine for patients with high-grade disease and validated folate receptor alpha (FRα) expression by immunohistochemistry, based on OS and PFS benefits demonstrated in the phase 3 MIRASOL trial (NCT04209855). Other strongly recommended options include PLD monotherapy, bevacizumab plus chemotherapy, and paclitaxel on either a weekly or every-3-week schedule. The combination of relacorilant (Lifyorli) and nab-paclitaxel received a conditional recommendation based on data from the phase 3 ROSELLA trial (NCT05257408)."

Living guideline • Platinum resistant • Ovarian Cancer

NAPISTAR 1-01: Results of phase 1 dose escalation of monotherapy with TUB-040, a novel NaPi2b-targeting exatecan ADC, in patients (pts) with platinum-resistant ovarian cancer (PROC). (ASCO 2026) - P1/2 | "Median age: 62 years (34-81), ECOG PS 0-1, median prior lines: 4 (1-7), prior treatment included bevacizumab (84%), PARPi (76%), and mirvetuximab soravtansine (13%). TUB-040 was well tolerated with promising clinical activity at low doses, offering a potential new treatment option with a differentiated, favorable benefit–risk profile and a wide therapeutic window in PROC pts. Dose optimization is currently ongoing."

ADC • Clinical • Monotherapy • P1 data • Platinum resistant • Alopecia • Constipation • Gastroenterology • Gastrointestinal Disorder • High Grade Serous Ovarian Cancer • Immunology • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pneumonia • Solid Tumor • MUC16 • SLC34A2

PROBE: Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer (clinicaltrials.gov) - P2 | N=225 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pancreatic Cancer • Solid Tumor • ER • PGR

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

CLINICAL BENEFIT OF MIRVETUXIMAB SORAVTANSINE IN OVARIAN CANCER PATIENTS WITH HIGH FOLATE RECEPTOR ALPHA EXPRESSION: RESULTS FROM THE SORAYA STUDY (IGCS 2022) - "Patients must have received 1-3 prior therapies, including bevacizumab. Conclusions MIRV demonstrated anti-tumor activity by tumor reduction and DCR in heavily pretreated patients with FRα-high PROC. These data support MIRV as a potential practice-changing, biomarker-driven therapy."

Clinical • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Mirvetuximab soravtansine (MIRV) in recurrent platinum-sensitive ovarian cancer (PSOC) with high folate receptor-alpha (FRα) expression: Results from the PICCOLO trial (ESMO 2024) - P2 | "97.5% had prior taxanes, 81% prior poly (ADP-ribose) polymerase inhibitors (PARPi) [74.7% of whom progressed while on PARPi], 64.6% prior bevacizumab, 98.8% had 2+ prior lines of therapy, and BRCA status was 27.8% positive, 72.2% negative. MIRV demonstrated clinically meaningful antitumor activity and favorable tolerability in patients with FRα-high PSOC. The efficacy and safety data support the use of MIRV in PSOC patients with ≥ 2 prior platinum-containing regimens or platinum allergy. Clinical Trial: NCT05041257."

Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA • FOLR1