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clinical / clinicalGARNET trial, dostarlimab cervical and endometrial cancer, immunotherapy in gynecologic oncologyBispecific T-cell Engager Pioneer

Ana Oaknin

安娜·奥克宁

MD, PhD

🏢Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona(西班牙巴塞罗那瓦尔德赫布隆大学医院及肿瘤研究所)🌐Spain

Head, Gynecological Malignancies Program, Vall d'Hebron Institute of Oncology (VHIO); Attending Physician, Medical Oncology瓦尔德赫布隆肿瘤研究所妇科恶性肿瘤项目主任;医学肿瘤科主治医生

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Key Contributions

👥Biography 个人简介

Ana Oaknin, MD, PhD is Head of the Gynecological Malignancies Program at the Vall d'Hebron Institute of Oncology (VHIO) in Barcelona, one of Spain's premier academic cancer centres and a leading European site for early-phase oncology trials. She is internationally recognized for her pivotal role in the GARNET trial, the single-arm phase I/II study that first established robust clinical activity of dostarlimab — a PD-1 checkpoint inhibitor developed by GlaxoSmithKline/TESARO — in recurrent endometrial and cervical cancers with mismatch repair deficiency or microsatellite instability-high status. As a principal investigator and lead author of the GARNET endometrial cohort data, she contributed to the evidence supporting FDA accelerated approval of dostarlimab for dMMR recurrent endometrial cancer in 2021. Her broader research program encompasses early-phase investigation of antibody-drug conjugates (including mirvetuximab soravtansine, tisotumab vedotin, and upifitamab rilsodotin), immune combination strategies, and novel cell therapy approaches in gynecologic malignancies. Dr. Oaknin is active in ESGO, ENGOT, and GCIG (Gynecologic Cancer InterGroup) trial design committees and has authored over 150 peer-reviewed publications. Her translational research emphasizes characterizing the immune tumor microenvironment in gynecologic cancers and developing predictive biomarkers beyond MMR status.

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🧪Research Fields 研究领域

GARNET Trial — Dostarlimab Monotherapy in Recurrent Endometrial and Cervical CancersGARNET试验——dostarlimab单药治疗复发性子宫内膜癌和宫颈癌
Immunotherapy in Endometrial Cancer — dMMR/MSI-H Biomarker-Directed Approaches子宫内膜癌免疫治疗——dMMR/MSI-H生物标志物导向方法
Cervical Cancer — PD-1 Checkpoint Inhibition and Novel Systemic Therapies宫颈癌——PD-1检查点抑制与新型系统治疗
Early-Phase Clinical Trials in Gynecologic Malignancies at VHIOVHIO妇科恶性肿瘤早期临床试验
Antibody-Drug Conjugates in Ovarian, Endometrial, and Cervical Cancer卵巢癌、子宫内膜癌和宫颈癌中的抗体药物偶联物

🎓Key Contributions 主要贡献

GARNET Trial — Dostarlimab in dMMR Endometrial and Cervical Cancer

Served as lead investigator and corresponding author for key GARNET trial publications, a single-arm phase I/II study evaluating dostarlimab monotherapy in patients with recurrent or advanced endometrial cancer (Cohort A1: dMMR; Cohort A2: MMR-proficient) and cervical cancer. The dMMR endometrial cancer cohort (A1) demonstrated an ORR of 42.3% with a complete response rate of 12.7% and durable responses with median DoR not reached, representing a clinically meaningful signal in heavily pretreated patients. These data supported FDA accelerated approval of dostarlimab in April 2021 for dMMR recurrent endometrial cancer and formed the biological rationale for the RUBY phase III trial.

Cervical Cancer Immunotherapy and Antibody-Drug Conjugates

Led and participated in multiple early-phase trials investigating PD-1/PD-L1 checkpoint inhibitors and ADCs in recurrent/metastatic cervical cancer. Co-investigated tisotumab vedotin (TV) phase I/II data and contributed translational correlative analyses from GARNET cervical cancer cohorts examining PD-L1 expression, HPV integration status, and tumor-infiltrating lymphocyte density as predictive biomarkers. This work contributed to the FDA approval of tisotumab vedotin for recurrent/metastatic cervical cancer and provided mechanistic insight into immune evasion in HPV-driven malignancies.

VHIO Early-Phase Gynecologic Oncology Trial Program

Built and leads VHIO's Phase I/II gynecologic oncology trial platform, which has activated first-in-human and expansion trials of multiple novel agents across endometrial, ovarian, cervical, and rare gynecologic tumor types. Under her leadership, the program systematically incorporates tumor molecular profiling, circulating tumor DNA monitoring, and on-treatment biopsy programs to generate translational insights. VHIO has become one of the premier European sites for early-phase gynecologic oncology investigation under her direction.

ENGOT/GCIG Collaborative Trial Network Contributions

Active participant and committee member of ESGO, ENGOT, and GCIG — the major international cooperative groups in gynecologic oncology — contributing to protocol design, biomarker framework development, and scientific review for phase II/III trials. Co-authored consensus guidelines on immunotherapy use in gynecologic cancers and molecular testing recommendations for endometrial cancer clinical practice, shaping European standards for dMMR/MSI testing and treatment selection.

Representative Works 代表性著作

[1]

Dostarlimab for Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer (GARNET)

Journal of Clinical Oncology (2022)

Primary GARNET publication demonstrating durable ORR of 42.3% with dostarlimab monotherapy in dMMR recurrent endometrial cancer, supporting FDA accelerated approval.

[2]

Tisotumab Vedotin in Patients with Recurrent or Metastatic Cervical Cancer (innovaTV 204)

The Lancet Oncology (2021)

Phase II innovaTV 204 trial establishing tisotumab vedotin activity in recurrent/metastatic cervical cancer with ORR 24%, supporting FDA accelerated approval.

[3]

Cervical Cancer: ESMO Clinical Practice Guideline for Diagnosis, Treatment and Follow-up

Annals of Oncology (2023)

ESMO-endorsed cervical cancer clinical practice guideline incorporating immunotherapy approvals and ADC regimens into evidence-based treatment algorithms.

[4]

Endometrial Cancer: ESMO Clinical Practice Guideline

Annals of Oncology (2022)

ESMO guideline update incorporating molecular subtyping, immunotherapy, and PARP inhibitor data into endometrial cancer treatment recommendations.

🏆Awards & Recognition 奖项与荣誉

🏆ESGO Rising Star Award in Gynecologic Oncology
🏆SEOM (Spanish Society of Medical Oncology) Excellence in Research Award
🏆VHIO Outstanding Clinical Investigator Recognition
🏆GCIG Young Investigator Award

📄Data Sources 数据来源

Last updated: 2026-04-06 | All information from publicly available academic sources

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