Jemperli (dostarlimab-gxly)

This first real-world study of dostarlimab plus chemotherapy in advanced or recurrent endometrial cancer involved an older, more comorbid, and less selected population with more advanced disease than in RUBY. Survival outcomes were less favorable, but the safety profile was comparable.

P1/2, N=270, Not yet recruiting, G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica

This classification (refined in ProMisE and TransPORTEC) enables precise treatment: immunotherapy (pembrolizumab, dostarlimab) works excellently in dMMR/MSI-H tumors, PI3K/AKT/mTOR inhibitors and trastuzumab deruxtecan in selected molecular subtypes, and hormone therapy in ER-positive tumors. Integrating the molecular profile with FIGO allows for truly personalized treatment, although MMRp/MSS tumors remain a challenge. The future lies in multi-omics, new biomarkers, and combination therapies.

P2, N=30, Not yet recruiting, University Health Network, Toronto

P2, N=10, Recruiting, Universitaire Ziekenhuizen KU Leuven | Not yet recruiting --> Recruiting

P2, N=66, Active, not recruiting, University of Oklahoma | Trial primary completion date: Dec 2025 --> Dec 2026

RWE confirms the effectiveness and safety of multiple recently approved oncology drugs reinforcing the external validity of RCTs.

P2, N=120, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2026 --> Dec 2029 | Trial primary completion date: Feb 2026 --> Dec 2029

P1/2, N=40, Recruiting, GlaxoSmithKline | Not yet recruiting --> Recruiting | Trial completion date: Jun 2029 --> Oct 2029 | Trial primary completion date: Apr 2028 --> Aug 2028

P2, N=62, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Feb 2026 --> Feb 2027 | Trial primary completion date: Feb 2026 --> Feb 2027

Treatment of LA HNSCC is multimodal and may include concomitant cisplatin-based chemoradiotherapy (CRT) or surgery; however, recurrence rates are high, and there is an unmet need for new treatments. The primary endpoint is event-free survival, with overall survival as a key secondary endpoint; safety and tolerability, pharmacokinetics, immunogenicity, biomarkers, and patient-reported outcomes will also be assessed. www.clinicaltrials.gov identifier is NCT06256588.

The analysis focuses on treatments that have demonstrated clinical benefit in advanced or recurrent disease, including pembrolizumab, dostarlimab, tisotumab vedotin, and mirvetuximab soravtansine. Their growing integration into clinical practice has reshaped therapeutic approaches, while ongoing research continues to refine optimal combinations, address resistance, and enhance biomarker-guided selection. Future developments are expected to unite immunologic, genomic, and computational strategies to achieve personalized and durable outcomes for patients with gynecologic malignancies.