ESMO 2026 gynecological cancer round-up: The key clinical trials in cervical, endometrial and ovarian cancer

ESMO 2026 put gynecological oncology in the spotlight, with new survival data, phase III trial results and emerging therapies bringing cervical, endometrial and ovarian cancer into focus.

Prof Domenica Lorusso (Global Lead Investigator, TroFuse-005 trial)

The European Society for Medical Oncology (ESMO) Congress 2026 featured new evidence across cervical, endometrial and ovarian cancer, including updates from BEATcc, KEYNOTE-C93, TroFuse-005, DUO-E and BEHOLD-1. The studies examined the role of immunotherapy, antibody–drug conjugates (ADCs) and targeted agents across first-line and previously treated settings. The findings included improved progression-free survival (PFS) with pembrolizumab in mismatch repair-deficient (dMMR) endometrial cancer, OS results from randomized studies and early efficacy data for investigational treatments in recurrent ovarian cancer. Other results highlighted areas where additional treatment did not significantly improve outcomes.

BEATcc: Final overall survival results with atezolizumab
Abstract: LBA38 | ClinicalTrials.gov: NCT03556839 | Phase: III

BEATcc evaluated the addition of atezolizumab to bevacizumab and platinum-based chemotherapy in patients with previously untreated metastatic, persistent or recurrent cervical cancer. At a median follow-up of 57.2 months, final overall survival (OS) results showed a significant improvement with atezolizumab (HR, 0.69; 95% CI, 0.54–0.88). Median OS was 31.9 months with atezolizumab versus 22.7 months with the control regimen, while 4-year OS rates were 40% versus 26%, respectively.

Key clinical takeaway: The sustained OS benefit supports adding atezolizumab to first-line chemotherapy and bevacizumab for recurrent or metastatic cervical cancer. Exploratory analyses suggested that the benefit was observed irrespective of PD-L1 status.

TroFuse-005: Sacituzumab tirumotecan in previously treated endometrial cancer
Abstract: LBA11 | ClinicalTrials.gov: NCT06132958 | Phase: III

TroFuse-005/ENGOT-en23/GOG-3095 evaluated sacituzumab tirumotecan (sac-TMT), a TROP2-directed antibody–drug conjugate, versus treatment of physician’s choice (TPC) in 776 patients with previously treated advanced or recurrent endometrial cancer. At a median follow-up of 14.0 months, sac-TMT significantly improved progression-free survival (PFS; HR, 0.59; 95% CI, 0.50–0.70; p<0.0001) and overall survival (OS; HR, 0.68; 95% CI, 0.55–0.84; p=0.0001). The objective response rate (ORR) was also significantly improved. Grade ≥3 treatment-related adverse events occurred in 54.4% versus 41.4% of patients.

Key clinical takeaway: Sac-TMT demonstrated statistically significant and clinically meaningful improvements in PFS, OS and ORR, with manageable safety, supporting its potential as a new treatment option for this population.

KEYNOTE-C93: Pembrolizumab versus chemotherapy in first-line dMMR endometrial cancer
Abstract: LBA12 | ClinicalTrials.gov: NCT05173987 | Phase: III

KEYNOTE-C93/GOG-3064/ENGOT-en15 compared first-line pembrolizumab monotherapy with carboplatin plus paclitaxel (CP) in 299 patients with advanced or recurrent mismatch repair-deficient (dMMR) endometrial carcinoma. At a median follow-up of 36.5 months, pembrolizumab demonstrated a statistically significant, clinically meaningful and durable improvement in progression-free survival (PFS), with a favorable trend in overall survival (OS). Grade ≥3 treatment-related adverse events occurred in 18.1% of patients receiving pembrolizumab versus 50.7% receiving CP. Clinically meaningful improvement in global health status/quality of life was also observed with pembrolizumab.

Key clinical takeaway: The findings support pembrolizumab monotherapy as a first-line treatment option for this population.

DUO-E: Updated overall survival results with durvalumab and olaparib
Abstract: LBA37 | NCT04269200 | Phase: III

DUO-E/GOG-3041/ENGOT-EN10 evaluated durvalumab plus carboplatin and paclitaxel (CP), followed by maintenance durvalumab with or without olaparib, in patients with advanced or recurrent endometrial cancer. In this randomized phase III study, 718 patients were assigned to CP (n=241), CP plus durvalumab (n=238) or CP plus durvalumab and olaparib (n=239). At an interim overall survival (OS) analysis (52% maturity), hazard ratios versus CP were 0.87 (95% CI, 0.68–1.11; p=0.259) and 0.77 (95% CI, 0.60–0.98; p=0.037), respectively.

Key clinical takeaway: Interim results favored both durvalumab-containing regimens, although only the durvalumab–olaparib regimen showed a statistically significant OS result. Follow-up for final OS and safety continues.

NRG-GY020: Pembrolizumab plus radiotherapy in early-stage dMMR endometrial cancer
Abstract: 1239O | NCT04214067 | Phase: III

NRG-GY020 evaluated pembrolizumab plus radiotherapy versus radiotherapy alone in patients with early-stage, high-intermediate-risk mismatch repair-deficient (dMMR) endometrioid endometrial cancer. This randomized phase III study enrolled 168 patients. At a median follow-up of 45.5 months, three-year recurrence-free survival (RFS) was 73% with radiotherapy alone versus 70% with the combination (Z = −0.48; p = 0.68). Kaplan–Meier-estimated RFS was 81% versus 88%, respectively (HR, 0.72; 95% CI, 0.33–1.61; p = 0.21). Grade 3 or 4 toxicity occurred in 15% versus 43%.

Key clinical takeaway: Pembrolizumab did not meet the prespecified criteria for superiority. Radiotherapy alone remains the standard of care for this population.

DOVACC: Olaparib, durvalumab and UV1 vaccination as maintenance therapy
Abstract: LBA39 | NCT04742075 | Phase: II

DOVACC/ENGOT-OV56/NSGO-CTU-DOVACC evaluated olaparib alone, olaparib plus durvalumab, or olaparib plus durvalumab and the investigational therapeutic vaccine UV1 as maintenance therapy in patients with BRCA wild-type recurrent ovarian cancer. In this randomized phase II study of 188 patients, median progression-free survival (PFS) was 8.7 months (95% CI, 6.1–11.3) with the three-drug combination versus 5.9 months (95% CI, 5.3–8.2) with olaparib alone (HR, 0.83; 95% CI, 0.68–1.01; p=0.066) at a median follow-up of 22.6 months. A post hoc exploratory analysis found a restricted mean survival time difference of 2.5 months at 22 months (95% CI, 0.1–4.9; p=0.043). PFS was significantly better in PARP inhibitor (PARPi)-naïve than PARPi-pretreated patients across all arms.

Key clinical takeaway: The primary PFS analysis did not demonstrate a statistically significant improvement with the addition of durvalumab and UV1 to olaparib. The exploratory analysis suggested a potential benefit but requires cautious interpretation. Prior PARPi exposure was also associated with PFS outcomes.

BEHOLD-1: Mocertatug rezetecan in platinum-resistant ovarian cancer
Abstract: LBA41 | NCT06431594 | Phase: I

BEHOLD-1 evaluated mocertatug rezetecan, an investigational B7-H4-directed ADC, in patients with platinum-resistant ovarian cancer. The open-label phase I study included dose-selection cohorts receiving different doses every three weeks. In the 5.8 mg/kg cohort, which included 45 patients, the confirmed objective response rate was 62% (n=28/45; 95% CI, 46.5–76.2%) at a median follow-up of 13.4 months. Median duration of response was 12.2 months (95% CI, 7.0–12.7), and median PFS was 11.1 months (95% CI, 8.3–13.9). Grade 3 or higher treatment-related adverse events occurred in 71% of patients at this dose.

Key clinical takeaway: The results provide early evidence of antitumor activity with mocertatug rezetecan in platinum-resistant ovarian cancer. The response and PFS findings support further clinical investigation, although the single-arm phase I design limits comparisons with established treatments. The frequency of grade 3 or higher treatment-related adverse events also underscores the importance of continued safety assessment.

DENALI: Overall survival with azenosertib in platinum-resistant ovarian cancer
Abstract: 1242RO | NCT05128825 | Phase: II

DENALI evaluated azenosertib, an investigational WEE1 inhibitor, in patients with platinum-resistant ovarian cancer (PROC). In Part 1b, 102 patients were enrolled, of whom 94 were evaluable for Cyclin E1 immunohistochemistry (IHC). As of September 2, 2025, median overall survival (OS) was 15.8 months (95% CI, 8.7–17.8) in Cyclin E1-positive patients (n=48), 7.5 months (95% CI, 5.8–12.3) in Cyclin E1-negative patients (n=46) and 12.3 months (95% CI, 8.7–16.1) overall.

Key clinical takeaway: The investigators identified Cyclin E1 as a predictive biomarker supporting further evaluation of azenosertib in biomarker-selected patients. Updated data were anticipated at presentation.

INCB123667 plus bevacizumab in recurrent epithelial ovarian cancer
Abstract: 1241RO | NCT05238922 | Phase: I

This phase I study evaluated INCB123667, an investigational cyclin-dependent kinase 2 (CDK2) inhibitor, plus bevacizumab in 23 patients with recurrent epithelial ovarian cancer who had received a median of 3 prior lines of systemic therapy. The objective response rate (ORR) was 48% (n=11; 95% CI, 26.8–69.4), and the disease control rate (DCR) was 91% (n=21; 95% CI, 72.0–98.9). Median duration of response (DOR) was 5.6 months (95% CI, 2.1, not estimable), with responses ongoing in eight patients. Updated progression-free survival (PFS) data were to be presented. Grade 3 or 4 treatment-emergent adverse events occurred in 52% of patients, with no discontinuations due to adverse events.

Key clinical takeaway: The combination demonstrated preliminary antitumor activity in heavily pretreated patients with recurrent epithelial ovarian cancer. Further data, particularly on PFS and response durability, are needed to clarify clinical benefit. Toxicity was manageable with dose modifications in this phase I study.

This content has been developed independently by Touch Medical Media for touchONCOLOGY. It is not affiliated with the European Society for Medical Oncology (ESMO). Views expressed are the speaker’s own and do not necessarily reflect the views of Touch Medical Media. This article was created by the editorial team utilizing AI as an editorial tool (Claude.AI and ChatGPT 5.5). The content was developed and edited by human editors. No funding was received in the publication of this article.

Cite: ESMO 2026 gynecological cancer round-up: The key clinical trials in cervical, endometrial and ovarian cancer. touchONCOLOGY. 27th October 2026.

Editor: Sophie Nickelson