In 2025, the field of Antibody-Drug Conjugates (ADCs) for gynecological tumors entered a critical period of target refinement and clinical translation. Vedetuximab was approved for the cervical cancer indication, while research on classic targets such as HER2 and FRα added significant new data. Breakthroughs were made in the exploration of novel targets, and domestic expert consensus was simultaneously established, marking the transition of this field from clinical exploration to standardized application. Obstetrics and Gynecology Network invited Professor Zhou Jinhua from the First Affiliated Hospital of Soochow University to systematically review the year's core progress and look ahead to the future direction of the field from three dimensions: the development history of ADCs, target exploration, and future innovations, providing professional reference for clinical diagnosis and treatment.

Gynecological tumors, primarily cervical cancer (CC), endometrial cancer (EC), and ovarian cancer (OC), are a major category of diseases threatening women's health. In 2022, the incidence rate of cervical cancer among Chinese women was 21.81 per 100,000, with a mortality rate of 8.06 per 100,000; the incidence rate of uterine corpus tumors was 11.25 per 100,000, with a mortality rate of 1.96 per 100,000; and the incidence rate of ovarian cancer was 8.84 per 100,000, with a mortality rate of 4.73 per 100,000 [1]. Currently, the treatment of gynecological malignancies is still mainly based on surgery, radiotherapy, and chemotherapy. Traditional chemotherapy lacks tumor specificity and causes significant damage to normal cells. Severe adverse reactions often make it difficult for patients to tolerate, thereby affecting the treatment outcome [1, 2].

Precise and effective targeted therapy has been a hot topic in clinical research and treatment updates in recent years. However, traditional targeted therapies often lack strong cytotoxicity and are prone to drug resistance. Therefore, how to accurately deliver cytotoxic drugs to target tumor cells while avoiding damage to normal cells is a challenge to be solved in tumor drug therapy [2, 3].

Exploration of "Magic Bullet" ADC Drugs in Gynecological Tumors

Figure 1: Overview of mechanisms by which ADCs kill cancer cells through different pathways (top left) [25]. Top right: Main core mechanisms of action of ADCs; Bottom left: The antibody component of ADCs binds to immune effector cells, triggering anti-tumor immunity, including Complement-Dependent Cytotoxicity (CDC), Antibody-Dependent Cellular Cytotoxicity (ADCC), and Antibody-Dependent Cellular Phagocytosis (ADCP) effects; Bottom right: The antibody component of ADCs retains its functional characteristics, thus it can interfere with target function and inhibit downstream signaling to suppress tumor growth.

Figure 2: Core components and characteristics of ADC drugs [25]: Target antigen, Antibody, Linker, Cytotoxic drug.

Antibody-Drug Conjugates (ADCs) are an emerging class of therapeutic drugs. With the deepening understanding of ADC mechanisms and technological updates and breakthroughs, 16 ADCs have been approved globally, of which 7 are approved in China. The development of ADC drugs for gynecological tumors did not start in isolation but followed the logic of expansion driven by tumor molecular characteristics. Early successes of ADCs were mainly concentrated in large cancer types such as hematological tumors, breast cancer, gastric cancer, and lung cancer, perhaps due to the large patient base and the discovery of a high proportion of target expression through immunohistochemistry or genetic testing. After the efficacy and safety of the drugs were verified, they were extended to gynecological tumors based on the commonality of molecular characteristics, following a natural development path from "large cancer types — molecular characteristics — gynecological tumors." ADCs are also flourishing in the field of gynecological tumors, with two drugs already approved for marketing (Vedetuximab: approved for cervical cancer in March 2025; Mirvetuximab Soravtansine: approved for ovarian cancer in November 2024). Meanwhile, multiple clinical trials are ongoing, and preliminary results show that ADCs have good application prospects in the treatment of gynecological tumors [2, 3].

Figure 3: Timeline of development and approval for marketing of "Magic Bullet" ADC drugs [25]. In China, ADC drugs approved for indications in gynecological tumors include: Mirvetuximab Soravtansine: approved in November 2024 for the treatment of Folate Receptor Alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) in patients who have received 1-3 prior lines of systemic therapy; Vedetuximab: approved in March 2025 for the treatment of patients with recurrent or metastatic cervical cancer who have progressed during or after systemic therapy.

The ideal ADC antibody should target tumor antigens that are highly expressed only in tumor tissue and low in healthy tissue. For example, Human Epidermal Growth Factor Receptor 2 (HER2) is expressed 100 times higher in tumors than in normal cells. Current target selection typically includes antigens overexpressed on tumor cells or antigens encoded by driver genes, such as Folate Receptor Alpha (FRα), Trophoblast Cell Surface Antigen 2 (Trop-2), Prostate-Specific Membrane Antigen (PSMA), Mesothelin, Neural Cell Adhesion Molecule-1 (CD56), CD70, Nectin Cell Adhesion Molecule 4 (Nectin-4), Human Epidermal Growth Factor Receptor 2 (HER2), Epidermal Growth Factor Receptor (EGFR), etc. [3]. Currently, ADC development in gynecological tumors focuses on HER2, FRα, Tissue Factor (TF), Trop-2, B7-H4 protein (B7 Homolog 4, VTCN1), Sodium-Dependent Phosphate Transporter IIb (NaPi2b), Protein Tyrosine Kinase 7 (PTK7), etc. [2, 3]. Compared to chemotherapy and immunotherapy, ADCs offer more precise killing and potentially better tolerance, but their adverse event profile is less familiar and management is challenging. In gynecological tumors (cervical cancer, endometrial cancer, ovarian cancer), ADCs have improved Objective Response Rate (ORR) and Progression-Free Survival (PFS) in multiple trials, but whether they can change the final survival outcome (Overall Survival, OS) still requires validation and long-term follow-up [4].

Figure 4: Important target antigens based on tumor cells (overexpression and driver gene-related) and the tumor microenvironment (vascular system and stroma) used in the development of Antibody-Drug Conjugates [25].

Human Epidermal Growth Factor Receptor 2 (HER2) ADC

HER2, as a classic oncogenic driver, is one of the earliest and most typical molecular targets in breast cancer. It was later discovered that a high proportion of HER2 amplification also exists in gastric cancer. The DESTINY-Breast and DESTINY-Gastric series of studies accelerated the approval of the HER2-targeted drug Trastuzumab Deruxtecan (T-DXd) in the treatment of related cancers. HER2 mutations and amplifications in lung cancer also extended the research of HER2 drugs to the direction of lung cancer (DESTINY-Lung). With the deepening of molecular pathology research, it was found that about half of endometrial serous carcinomas have HER2 overexpression or amplification, which often indicates a poor prognosis. Based on the successful experience of HER2 ADCs in breast and lung cancer, related drugs have been extended to gynecological tumors. HER2 ADCs such as Trastuzumab Deruxtecan (T-DXd, DS-8201a), Disitamab Vedotin (RC48), and SHR-A1811 have shown preliminary efficacy in related clinical trials in gynecological tumor populations. HER2 targeting has thus achieved cross-cancer development from large cancer types to gynecological tumors [2].

DESTINY-PanTumor02 (NCT04482309) is a global, multicenter, multi-cohort, open-label, Phase II trial conducted in patients with solid tumors. It enrolled patients with HER2-overexpressing (IHC 3+ or 2+) gynecological tumors (endometrial cancer cohort n=40, cervical cancer cohort n=40 [including 5 patients with IHC 1+], ovarian cancer cohort n=40). Regardless of the type of gynecological tumor, Trastuzumab Deruxtecan (T-DXd, DS-8201a) treatment showed better ORR in IHC 3+ patients than in IHC 2+ patients. The ORR for the entire population of endometrial cancer patients reached 57.5%, for cervical cancer patients 50%, and for ovarian cancer patients 45%, far exceeding the ORR of other solid tumor patients included in the study [5]. At the 2025 European Society for Medical Oncology (ESMO) Congress, DESTINY-PanTumor02 also announced patient PFS and OS data: median PFS for the entire population of endometrial cancer patients reached 11.1 months, for cervical cancer patients 7.0 months, and for ovarian cancer patients 5.9 months; median OS for the entire population of endometrial cancer patients reached 24.3 months, for cervical cancer patients 13.6 months, and for ovarian cancer patients 13.2 months [6]. Based on the strong data from DESTINY-PanTumor02 and other studies, the U.S. Food and Drug Administration (FDA) granted accelerated approval in April 2024 for Trastuzumab Deruxtecan for the treatment of patients with unresectable or metastatic HER2-positive solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. Another study, STATICE (NCCH1615) [7], found that Trastuzumab Deruxtecan showed high ORR in both HER2-high and HER2-low expressing uterine sarcomas (including uterine leiomyosarcoma-like/carcinosarcoma) (HER2-high about 54.5%, HER2-low about 70%), suggesting that the bystander effect may also benefit HER2-low expressing patients. Due to the superior performance of Trastuzumab Deruxtecan in gynecological tumors, following DESTINY-PanTumor02, the DESTINY-PanTumor03 study specifically for the Chinese population (Phase II open, multicenter study, enrolling gynecological tumor patients with IHC 3+/2+/1+, NCT06271837) and the DESTINY-Endometrial01 study in endometrial cancer patients (global multicenter, open-label, randomized controlled Phase III clinical trial, NCT06989112) were also initiated.

RC48-C018 study is an open-label, multicenter, Phase II basket study that enrolled patients with HER2-expressing gynecological malignancies. Results of Disitamab Vedotin treatment for recurrent or metastatic cervical cancer patients (Cohort 1, n=30) were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting [8]: Among 26 evaluable patients, the confirmed Objective Response Rate (cORR) was 26.9%, and the confirmed Disease Control Rate (cDCR) was 80.8%; median PFS for 21 patients was 4.37 months, median OS was 12.68 months, and the 12-month OS rate was 57%. Another single-arm, open-label, multicenter Phase II study named Diversity, aimed at exploring the efficacy of Disitamab Vedotin combined with carboplatin ± bevacizumab in HER2-expressing platinum-sensitive ovarian cancer patients (n=10, NCT06420973), was presented at the 2025 ASCO Annual Meeting [9]: Efficacy was evaluated in 10 patients, with a median follow-up time of 3.2 months, ORR: 70%, DCR 100%.

The treatment of IHC3+ or 2+ gynecological tumor patients with Trastuzumab Deruxtecan and the treatment of HER2-expressing recurrent or metastatic cervical cancer patients with Disitamab Vedotin have been included and recommended in the "Expert Consensus on Clinical Application of Antibody-Drug Conjugates in Gynecological Tumors" [10].

In addition to the above two HER2 ADCs, results from another Phase II study of a novel HER2-targeting ADC, SHR-A1811, in HER2-expressing advanced gynecological tumors were presented at the 2025 ASCO Annual Meeting [11]. This study was a dose-exploration study where patients received SHR-A1811 at 4.8 or 6.4 mg/kg (Q3W, IV). The primary endpoint was ORR as defined by RECIST v1.1. A total of 108 patients were enrolled (46 OC patients, 27 EC patients, and 35 CC patients). The cORR for all patients in OC, EC, and CC were 56.1%, 50.0%, and 63.6%, respectively; median PFS was 8.5 months, 5.6 months, and 10.7 months, respectively. In the 4.8 mg/kg cohort, the cORR for OC, EC, and CC patients were 56.8%, 52.0%, and 61.3%, respectively, and PFS was 8.5 months, 7.2 months, and 10.7 months, respectively.

Table 1: Summary of research results for targeted HER2 ADC drugs.

Although targeted HER2 ADCs bring hope for survival to patients with advanced gynecological tumors, Interstitial Lung Disease (ILD) needs to be guarded against during treatment. Early multidisciplinary team (MDT) collaboration with other disciplines for early identification and management of ILD and graded management is an effective method [12].

Folate Receptor Alpha (FRα) ADC

Folate Receptor Alpha (FRα) is almost not expressed in normal tissues but shows high levels of expression in epithelial ovarian cancer and some endometrial cancers, and is associated with malignant biological behavior of tumors. This "tumor-specific" distribution pattern provides an ideal safety window for ADCs [2, 3]. Based on this characteristic, FRα-targeting ADCs such as Mirvetuximab Soravtansine (MIRV), composed of an FRα-binding antibody and the microtubule-disrupting drug maytansinoid DM4, were able to conduct large-scale clinical trials in the ovarian cancer population, ultimately leading to the approval of the first FRα ADC for FRα-positive platinum-resistant ovarian cancer in patients who have received 1-3 prior lines of systemic therapy (Phase II SORAYA study [NCT04296890 [13, 14]], Phase III MIRASOL study [NCT04209855 [15]]).

Progress in FRα ADCs in 2025 focused on the following two aspects: 1. Novel FRα ADC drugs (Luveltamab tazevibulin, Rinatabart Sesutecan, and AZD5335); 2. Attempts to extend the benefit from patients with FRα ≥75% to ≥25%, or even regardless of FRα expression.

A breakthrough oral presentation at the 2025 Society of Gynecologic Oncology (SGO) Annual Meeting reported on the REFRαME-O1 trial (NCT05870748) [16], which explored the efficacy of Luveltamab Tazevibulin (Luvelta) in patients with FRα expression ≥25% platinum-resistant ovarian cancer. The optimal dose selection for luvelta was determined to be 5.2 mg/kg + G-CSF for 2 cycles, followed by 4.3 mg/kg treatment, with an ORR of 32%.

Results from Dose Expansion Cohort B of a Phase I/II study of Rinatabart sesutecan (Rina-S®) (RAINFOL-01 study, NCT05579366 [17]) were also presented at the 2025 SGO, ASCO, and ESMO meetings: Regardless of FRα expression, in advanced ovarian cancer, cORR was 55.6% with Rina-S 120 mg/m² and 22.7% with Rina-S 100 mg/m² [18]; regardless of FRα expression, in advanced endometrial cancer, cORR was 50.0% with Rina-S 100 mg/m² and 44.1% with Rina-S 120 mg/m² [19].

The FONTANA study is a first-in-human study of AZD5335 in patients with advanced solid tumors (Phase I/IIa open-label, NCT05797168). Preliminary data from the AZD5335 monotherapy dose optimization (Part B1) were reported at the 2025 ESMO Congress. Part B1 enrolled platinum-resistant ovarian cancer patients with ≤3 prior lines of therapy, grouped according to FRα expression, and received AZD5335 intravenous injection every 3 weeks, with dose optimization set at 1.6, 2.0, and 2.4 mg/kg. As of March 14, 2025, the median treatment exposure time was 3.8 months, and 107 patients (58.5%) were still on treatment at data cutoff. High FRα expression (≥75% tumor cells, staining intensity ≥2+, n=56): Combined ORR across the three dose levels (1.6, 2.0, 2.4 mg/kg) was 60.7%. Low FRα expression (≥25% tumor cells, staining intensity ≥1+, n=61): Combined ORR across the three dose levels was 47.5%. [20]

Table 2: Summary of research results for targeted FRα ADC drugs.

Ocular toxicity needs to be guarded against during the use of targeted FRα ADCs. The occurrence of ocular toxicity caused by Mirvetuximab Soravtansine is mostly due to off-target effects. It is recommended that patients prophylactically use corticosteroid-containing/lubricating eye drops, apply cold compresses daily, use vasoconstrictor eye drops, and conduct ophthalmology MDT as much as possible during drug use [4, 12].

Other Targeted ADC Drugs

TROP2 is a transmembrane glycoprotein widely present in various epithelial tumor cells and plays a role in tumor proliferation and invasion. Sacituzumab Govitecan (IMMU-132) has been approved for breast cancer and urothelial carcinoma. Since TROP2 is also highly expressed in most endometrial cancers [2], the IMMU-132-01 basket study (NCT01631552) initiated cross-cancer exploration in the field of gynecological tumors [21]. The study enrolled 18 patients with metastatic endometrial cancer who had received at least one prior systemic platinum-containing chemotherapy. Sacituzumab Govitecan treatment resulted in an ORR of 22.2%, median PFS of 3.2 months, and median OS of 11.9 months, showing some remission rate and survival benefit. However, the data are still limited, and more research is needed to further verify its clinical value.

In addition to the main targets mentioned above, some molecular targets in the exploratory stage are gaining more attention. CDH6 is highly expressed in ovarian cancer and renal cancer, and related ADCs are in early trials. B7-H4, as an immune checkpoint molecule, is widely overexpressed in gynecological tumors such as ovarian cancer and endometrial cancer, with very low expression in normal tissues, making it an emerging direction for ADC development in recent years [2, 3]. A Phase I/IIa open-label study in patients with advanced solid tumors (BLUESTAR, NCT05123482) showed [22]: The B7-H4 ADC Puxitatug samrotecan (AZD8205) showed durable benefit in patients with endometrial cancer, ovarian cancer, and breast cancer, with 12-week DCR rates of 75%, 70.6%, and 58.3%, respectively. NaPi2b is positive in over 90% of ovarian cancers but is basically not expressed in normal tissues, which has driven the clinical development of ADCs such as Lifastuzumab vedotin (LIFA) and Upifitamab rilsodotin (UpRi). Although subsequent large-scale trial results did not meet expectations or showed intolerable toxicity leading to the suspension of research [23], it still demonstrated the potential of this target [2, 12]. These exploratory target studies indicate that the development of ADCs for gynecological tumors is constantly expanding into new directions, and breakthroughs may be achieved in the future through more precise molecular typing and patient selection strategies.

Summary and Outlook

In summary, the selection of ADC targets in gynecological tumors is often based on two aspects: first, the lead experience from large cancer types, and second, the molecular characteristic advantages of the tumor tissue itself. In addition to positive expression of HER2, FRα, Trop-2, etc., it is recommended to evaluate receptor density, internalization efficiency, bystander effect, and immune characteristics of the tumor microenvironment, and integrate predictive responses with modern AI technology. However, attention also needs to be paid to drug accessibility and promoting the standardization of companion diagnostics to select advantageous patients and balance drug efficacy with the patient's comprehensive disease burden [24].

In today's era where precision medicine is the main theme of cancer treatment, ADCs, by integrating the specificity of antibodies and the potency of chemotherapeutic drugs, demonstrate great potential and broad prospects in the treatment of gynecological tumors. Future development directions will include optimizing target selection, improving linker and payload structures to enhance stability and release precision, combining with immunotherapy or other targeted drugs to delay resistance, and promoting biomarker testing to achieve more precise patient selection [10, 23]. With the continuous improvement of next-generation ADC technology and the accumulation of more, more comprehensive, and larger sample size clinical trial evidence, ADC drugs are expected to bring more efficient and safer treatment options to patients with gynecological tumors.

References:

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Expert Profile

Zhou Jinhua, Professor

The First Affiliated Hospital of Soochow University

Chief Physician, Professor, Doctoral Supervisor, Postdoctoral Supervisor

Deputy Director, Department of Obstetrics and Gynecology, The First Affiliated Hospital of Soochow University; Secretary of the First Party Branch

❖ Postdoctoral Fellow, MD Anderson Cancer Center

❖ Academic Leader, Jiangsu Provincial Clinical Key Specialty

❖ Member, Youth Group, Chinese Society of Gynecological Oncology, Chinese Medical Association

❖ Member, Cervical Lesions Group, Chinese Society of Obstetricians and Gynecologists

❖ Member, Gynecological Oncology Committee, Chinese Society of Clinical Oncology (CSCO)

❖ Standing Committee Member, Jiangsu Society of Obstetrics and Gynecology

❖ Vice Chairman, Gynecological Oncology Committee, Jiangsu Research Hospital Association

❖ Vice Chairman, Gynecological Oncology Committee, Jiangsu Anti-Cancer Association

❖ Vice Chairman, Suzhou Society of Obstetrics and Gynecology

❖ Vice Chairman, Suzhou Society of Gynecological Oncology

❖ Deputy Director, Suzhou Gynecological Medical Quality Control Center

❖ Candidate, Jiangsu "333 Talent Project"

❖ Key Project Member, National Science and Technology Major Project for "Four Major Chronic Diseases"; has presided over 4 National Natural Science Foundation projects; published 30 SCI papers as first/corresponding author (including co-author), with a cumulative impact factor of over 200 points, including 5 papers with IF >10.

Responsible Editor:Lily