LBA27 - APEX-Breast01: TQB2102 Versus Chemotherapy in HER2-Low Recurrent or Metastatic Breast Cancer (R/M BC) - Results from A Randomized Phase 3 Study

Presenter: Shusen Wang

Background

TQB2102 is a biparatopic antibody–drug conjugate (ADC) targeting HER2. Earlier phase 1 and phase 1b studies indicated antitumour activity in heavily pretreated patients with HER2-low metastatic breast cancer, defined as IHC 1+ or IHC 2+/ISH−. The phase 3 APEX-Breast01 trial compared TQB2102 with standard chemotherapy.

Aim

To evaluate the efficacy and safety of TQB2102 versus treatment of physician’s choice (TPC) in HER2-low recurrent or metastatic breast cancer.

Methods

Results

• 543 patients randomized: TQB2102 (n=269) vs Treatment of Physician’s Choice (TPC; n=274).
• 461 patients were HR-positive; 91.3% had received prior CDK4/6 inhibitor therapy.
• Baseline characteristics were balanced: 
  • HER2 IHC 1+ status: 58.3% vs 57.9%
  • Prior taxane exposure: 62.3% vs 61.8%

HR+/HER2-low Population (n=228 vs 233)

• Median PFS: 16.4 vs 5.5 months (HR 0.29; p<0.0001)
• ORR: 66.7% vs 31.3%
• OS: HR 0.47, favoring TQB2102

All HER2-low Population

• Median PFS: 16.4 vs 5.5 months (HR 0.29; p<0.0001)
• ORR: 68.8% vs 31.0%
• OS: HR 0.44, favoring TQB2102
• OS data remain immature but show a positive trend for TQB2102.

HR-/HER2-low Population (n=41 per arm)

• Median PFS: 8.5 vs 5.4 months (HR 0.27)
• ORR: 80.5% vs 29.3%
• OS: HR 0.21 (immature due to small sample size)

Safety

• Most common Grade ≥3 TRAEs: 
  • Decreased neutrophil count: 30.1% vs 23.3%
  • Decreased WBC count: 21.6% vs 14.0%
• TRAE-related discontinuations: 1.5% in both arms.
• Interstitial lung disease (ILD): 2.2% (6 patients) with TQB2102; Grade 3 ILD in 1.1%.

Conclusion

TQB2102 demonstrated a significant and clinically meaningful improvement in progression-free survival, higher response rates, and a favorable trend toward overall survival compared with physician’s choice chemotherapy, while maintaining a manageable safety profile in patients with HER2-low recurrent/metastatic breast cancer.

Reference 

Wang S. APEX-Breast01: TQB2102 versus chemotherapy in HER2-low recurrent or metastatic breast cancer (r/m BC) - results from a randomized phase 3 study, LBA27. Paper presented at: ESMO Congress 2026; October 23–27, 2026; Madrid, Spain

LBA24 - Final Analysis of NRG Oncology/NSABP B-42, A Randomized, Double-Blinded, Placebo-Controlled Trial of Extended Letrozole in Postmenopausal Women with Hormonereceptor Positive Breast Cancer who Have Completed Previous Adjuvant Therapy with An Aromatase Inhibitor

Presenter: Eleftherios Mamounas

Background

The NSABP B-42 trial examined extended endocrine therapy in postmenopausal women with HR-positive breast cancer who had completed 5 years of adjuvant endocrine treatment. The 10-year analysis showed significant improvements in disease-free survival (DFS), breast cancer-free interval (BCFI) and distant recurrence (DR), but not overall survival (OS). This report presents the final 15-year outcomes.

Aim

To assess long-term efficacy outcomes after 5 additional years of letrozole compared with placebo.

Methods

Results

  Median follow-up: 15.9 years; follow-up completed in August 2026. 

  538 additional DFS events were recorded since the 10-year analysis. 

  Disease-Free Survival (DFS): 

• Letrozole significantly improved DFS vs placebo.
• HR 0.85 (95% CI 0.77–0.94)
• 15-year DFS: 61.6% vs 56.5%

  Breast Cancer-Free Interval (BCFI): 

• Significant benefit with letrozole.
• HR 0.78 (95% CI 0.67–0.92)
• 15-year BCFI risk: 14.7% vs 18.3%

  Distant Recurrence (DR): 

• Reduced risk with letrozole.
• HR 0.72 (95% CI 0.57–0.91)
• 15-year DR risk: 6.9% vs 9.7%

  DFS benefit was consistent across all predefined subgroups. 

  Overall Survival (OS): 

• No statistically significant difference between groups.
• HR 0.92 (95% CI 0.82–1.05)
• 15-year OS: 74.0% vs 72.3%

Conclusion

Extended letrozole therapy provided a durable long-term reduction in breast cancer recurrence risk, with sustained improvements in DFS and other disease-control outcomes maintained through 15 years, although no significant overall survival benefit was observed.

Reference 

Mamounas EP. Final analysis of NRG Oncology/NSABP B-42, a randomized, double-blinded, placebo-controlled trial of extended letrozole in postmenopausal women with hormone-receptor positive breast cancer who have completed previous adjuvant therapy with an aromatase inhibitor, LBA24. Paper presented at: ESMO Congress 2026; October 23–27,2026;Madrid,Spain.

LBA25 - Adjuvant Ribociclib (RIB) + Nonsteroidal Aromatase Inhibitor (NSAI) in Patients (Pts) with HR+/HER2− Early Breast Cancer (EBC): NATALEE 6-Y Overall Survival (OS) and Efficacy Outcomes

Presenter: Dennis Slamon

Background

The phase 3 NATALEE trial previously demonstrated a significant invasive disease-free survival (iDFS) benefit from adding ribociclib to a nonsteroidal aromatase inhibitor (NSAI) for patients with high-risk stage II/III HR+/HER2− early breast cancer.

Aim

To report prespecified overall survival and other efficacy outcomes after 6 years of follow-up.

Methods

Results

  Median OS follow-up: 66.5 months; all patients had been off ribociclib for a median of 38 months and had completed planned NSAI therapy. 

  Overall Survival (OS): 

• Ribociclib + NSAI significantly improved OS vs NSAI alone.
• HR 0.81 (95% CI 0.66–0.99; P=0.019)
• Absolute OS benefit increased from 1.2% at 5 years (93.9% vs 92.7%) to 2.1% at 6 years (91.9% vs 89.7%).

  Breast Cancer-Specific Survival (BCSS): 

• HR 0.71 (95% CI 0.56–0.89), supporting the OS benefit.

  Invasive Disease-Free Survival (iDFS): 

• Sustained benefit with ribociclib.
• HR 0.74 (95% CI 0.65–0.85; P<0.0001)
• Absolute benefit increased from 4.1% at 5 years (85.3% vs 81.2%) to 5.3% at 6 years (83.2% vs 77.9%).

  Distant Disease-Free Survival (DDFS): 

• HR 0.74 (95% CI 0.65–0.86)

  Distant Recurrence-Free Survival (DRFS): 

• HR 0.74 (95% CI 0.63–0.86)

  Benefits were consistent across key patient subgroups. 

  No new safety signals were identified.

Conclusion

After 6 years, ribociclib plus NSAI continued to reduce recurrence risk and demonstrated a positive OS result, with absolute benefits increasing over time. These findings support adjuvant ribociclib plus NSAI across the broad NATALEE-eligible population with high-risk stage II/III HR+/HER2− early breast cancer.

Reference 

Slamon DJ. Adjuvant ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2− early breast cancer (EBC): NATALEE 6-y overall survival (OS) and efficacy outcomes, LBA25. Paper presented at: ESMO Congress 2026; October 23–27, 2026;Madrid,Spain

LBA50 - PANKU-Breast01: Randomized Phase III Study of Izalontamab Brengitecan (Iza-Bren) in Previously Treated Unresectable Locally Advanced or Metastatic (LA/M) Hormone Receptor-Positive/HER2-Negative (HR+/HER2-) Breast Cancer (BC)

Presenter: Bo Lan

Background

Although first-line endocrine therapy combined with CDK4/6 inhibitors has improved outcomes in HR+/HER2− breast cancer, resistance develops and outcomes with subsequent therapies remain poor. Izalontamab brengitecan (iza-bren) is a first-in-class bispecific ADC targeting EGFR and HER3, with a topoisomerase I inhibitor payload (Ed-04).

Aim

To compare the efficacy and safety of iza-bren with treatment of physician’s choice in previously treated unresectable locally advanced or metastatic HR+/HER2− breast cancer.

Methods

Results

• 383 patients randomized and treated: iza-bren (n=190) vs treatment of physician's choice (TPC; n=193).
• Median PFS follow-up: 15.24 months with iza-bren vs 13.63 months with TPC.
• BICR-assessed PFS: 
  • 8.18 months vs 4.01 months
  • HR 0.41 (95% CI 0.33–0.53; P<0.0001)
• Overall Survival (OS): 
  • Data remain immature.
  • No detrimental effect on OS observed.
• Objective Response Rate (ORR): 
  • 40.5% vs 20.2%
• Median Duration of Response (DoR): 
  • 6.93 months vs 4.21 months
• Safety: 
  • Grade ≥3 TRAEs were mainly hematologic and manageable with standard supportive care.
  • TRAE-related discontinuation: 1.6% with iza-bren.
  • Interstitial lung disease (ILD): 1.1% (2 patients), both Grade 1/2.
  • No new safety signals identified.

 

Conclusion

PANKU-Breast01 met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival with iza-bren versus physician’s choice therapy, with a manageable safety profile, supporting its potential as a new standard-of-care option for previously treated HR+/HER2− metastatic breast cancer after CDK4/6 inhibitors and taxanes in China.

Reference 

Lan B. PANKU-Breast01: Randomized phase III study of izalontamab brengitecan (iza-bren) in previously treated unresectable locally advanced or metastatic (LA/M) hormone receptor-positive/HER2-negative (HR+/HER2-) breast cancer (BC), LBA50. Paper presented at: ESMO Congress 2026; October 23–27, 2026; Madrid, Spain
 

LBA77 - Arcotatug Tavatecan (IBI343/TAK-921) Versus Treatment of Physician’s Choice (TPC) in Previously Treated, Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (G/GEJA): First Interim Analysis of The Randomized, Open-Label, Phase 3, G-HOPE-001 Study

Presenter: Kohei Shitara

Background

Arcotatug tavatecan is a CLDN18.2-targeted ADC comprising an Fc-silenced antibody designed to reduce on-target, off-tumour toxicity and an exatecan-derived topoisomerase I inhibitor payload. This report presents the first prespecified interim analysis of the phase 3 G-HOPE-001 study.

Aim

To compare arcotatug tavatecan with treatment of physician’s choice in previously treated advanced gastric or gastroesophageal junction adenocarcinoma.

Methods

Results

  408 patients from China and Japan were enrolled: arcotatug tavatecan (n=203) vs TPC (n=205). 

  Baseline characteristics: 

• 62.0% male
• Median age: 58 years
• 71.6% ECOG PS 1
• 81.6% gastric primary tumors
• 43.6% had prior primary tumor resection

  Progression-Free Survival (PFS): 

• 5.5 vs 2.9 months
• HR 0.47 (95% CI 0.34–0.65; p<0.0001)

  Overall Survival (OS): 

• 9.9 vs 7.4 months
• HR 0.63 (95% CI 0.45–0.89)

  Objective Response Rate (ORR): 

• 23.6% vs 5.3%

  Grade ≥3 TEAEs: 

• 45.8% vs 57.9%

  Common GI adverse events with arcotatug tavatecan vs TPC: 

• Nausea: 38.9% vs 40.6%
• Vomiting: 22.2% vs 28.4%
• Diarrhea: 12.8% vs 34.5%

  No interstitial lung disease (ILD) observed. 

  Treatment discontinuation due to TRAEs: 1.0% in both arms. 

  No fatal treatment-related adverse events reported.

Conclusion

Arcotatug tavatecan demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus physician's choice chemotherapy, with a manageable safety profile, supporting its potential role as a treatment option for CLDN18.2-positive gastric/gastroesophageal junction adenocarcinoma in the third-line or later setting; overall survival results remain immature and will be assessed at the prespecified final analysis.

Reference 

Shitara K. Arcotatug tavatecan (IBI343/TAK-921) versus treatment of physician’s choice (TPC) in previously treated, advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA): First interim analysis of the randomized, open-label, phase 3, G-HOPE-001 study, LBA77. Paper presented at: ESMO Congress 2026; October 23–27,2026;Madrid,Spain

LBA82 - Daraxonrasib, A RAS(ON) Multi-Selective Inhibitor Vs Chemotherapy in Previously Treated Metastatic Pancreatic Adenocarcinoma (Mpdac): Additional Subgroup Analyses from The Ph3 Rasolute 302 Study

Presenter: Zev Wainberg

Background

Multiagent chemotherapy offers limited benefit in metastatic pancreatic adenocarcinoma (mPDAC). More than 90% of cases harbour mutant RAS, while RAS wild-type tumours also depend on RAS pathway signalling. Daraxonrasib is an oral tri-complex inhibitor targeting active, GTP-bound mutant and wild-type RAS. The primary RASolute 302 analysis showed improved OS and PFS versus standard chemotherapy overall (median OS 13.2 vs 6.7 months; HR 0.40; median PFS 7.2 vs 3.6 months; HR 0.49) and in RAS G12-mutant disease (OS HR 0.40; PFS HR 0.45).

Aim

To examine OS outcomes with daraxonrasib across clinically relevant subgroups defined by tumour RAS status, chemotherapy regimen and prior-treatment disease setting.

Methods

• Previously treated patients with mPDAC were randomised 1:1 to daraxonrasib 300 mg orally once daily or investigator-selected standard chemotherapy: gemcitabine plus nab-paclitaxel, modified FOLFIRINOX, nanoliposomal irinotecan plus 5-fluorouracil/leucovorin, or FOLFOX. 
• Dual primary endpoints were OS and PFS in RAS G12-mutant disease; key secondary endpoints were OS and PFS in the overall population. 
• Additional OS analyses assessed locally determined RAS mutation status, preselected chemotherapy regimen and disease setting of prior treatment.

Results

• Median follow-up: 8.5 months (range 3.2-15.9 months).
• Treatment arms: Daraxonrasib (n=248) vs chemotherapy (n=252).
• Overall survival favored daraxonrasib across all evaluated RAS subgroups.
• KRAS G12D: HR 0.49 (95% CI 0.33-0.74), corresponding to a 51% reduction in risk of death.
• KRAS G12V: HR 0.32 (95% CI 0.19-0.54), corresponding to a 68% reduction in risk of death.
• KRAS G12R: HR 0.61 (95% CI 0.29-1.30).
• RAS Q61: HR 0.37 (95% CI 0.09-1.44).
• No identified RAS mutation: HR 0.43 (95% CI 0.09-1.98).
• OS benefit was consistent across preselected chemotherapy subgroups, with HRs ranging from 0.32 to 0.46.
• OS results by prior-treatment disease setting are pending and will be reported separately.

Conclusion

Daraxonrasib showed an OS advantage over chemotherapy across clinically relevant subgroups of previously treated mPDAC, including patients with and without an identified tumour RAS mutation. The consistency of the findings supports its potential as a future standard treatment option.

Reference 

Wainberg ZA. Daraxonrasib, a RAS(ON) multi-selective inhibitor vs chemotherapy in previously treated metastatic pancreatic adenocarcinoma (mPDAC): Additional subgroup analyses from the ph3 RASolute 302 study, LBA82. Paper presented at: ESMO Congress 2026; October 23–27, 2026; Madrid, Spain

LBA56 - Capivasertib (Capi) + Abiraterone (Abi) Vs Placebo (Pbo) + Abi In Patients (Pts) with PTEN-Deficient Metastatic Hormone-Sensitive Prostate Cancer (Mhspc): Updated Overall Survival (OS) from Capitello-281

Presenter: Karim Fizazi

Background

In de novo metastatic hormone-sensitive prostate cancer (mHSPC), PTEN deficiency is associated with poor prognosis despite current standard treatment. CAPItello-281 previously met its primary endpoint, showing a significant radiographic PFS (rPFS) benefit with capivasertib plus abiraterone versus placebo plus abiraterone in PTEN-deficient disease.

Aim

To report updated OS and rPFS outcomes after additional follow-up and explore outcomes across more stringent PTEN-deficiency thresholds.

Methods

Results

  1,012 patients randomized: Capivasertib + abiraterone (n=507) vs placebo + abiraterone (n=505). 

  Updated OS analysis: 421 deaths (41.6%) had occurred at data cutoff. 

  Median OS: 57.4 vs 46.5 months. 

  OS HR: 0.82 (95% CI 0.68-0.99; P=0.044). 

  Despite numerical OS improvement, the alpha-controlled descriptive analysis did not achieve statistical significance. 

  Primary OS analysis: 267 deaths (26.4%); median OS not reached in either arm. 

  Primary OS HR: 0.90 (95% CI 0.71-1.15; P=0.401). 

  Updated rPFS analysis: 532 events (52.6%). 

  Median rPFS: 35.5 vs 26.0 months. 

  rPFS HR: 0.83 (95% CI 0.70-0.99; nominal P=0.033). 

  Primary rPFS analysis: 398 events (39.3%). 

  Median rPFS: 33.2 vs 25.7 months. 

  Primary rPFS HR: 0.81 (95% CI 0.66-0.98; P=0.034). 

  In PTEN-deficient subgroups, OS benefit appeared greater, with HRs ranging from 0.76 to 0.74 as PTEN-deficiency thresholds increased from ≥95% to 100%. 

  Safety profile remained consistent after an additional 17 months of follow-up, with no new safety concerns identified.

 

Conclusion

With longer follow-up, the OS HR favoured capivasertib plus abiraterone more strongly than at the primary analysis, although statistical significance was not reached in the descriptive analysis. The rPFS benefit persisted and no change in the safety profile was observed.

Reference 

Fizazi K. Capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC): Updated overall survival (OS) from CAPItello-281, LBA56. Paper presented at: ESMO Congress 2026; October 23–27, 2026; Madrid, Spain

LBA79 - Zanidatamab (Zani) + Chemotherapy (CT) ± Tislelizumab (TIS) for First-Line (1L) HER2-Positive (HER2+) Advanced/Metastatic Gastroesophageal Adenocarcinoma (Mgea): Second Interim Analysis (IA) from HERIZON-GEA-01

Presenter: Kohei Shitara

Background

In the phase 3 HERIZON-GEA-01 trial, the primary PFS analysis and first OS interim analysis showed that zanidatamab plus chemotherapy, with or without tislelizumab, prolonged PFS versus trastuzumab plus chemotherapy. The tislelizumab-containing regimen also showed an OS benefit (HR 0.72), supporting first-line use in HER2-positive advanced or metastatic gastroesophageal adenocarcinoma.

Aim

To report the second interim OS analysis after longer follow-up.

Methods

Results

  914 patients were randomized; median follow-up was 35.3 months, extending 9.4 months beyond the first interim analysis. 

  Zanidatamab + chemotherapy significantly improved overall survival (OS) versus trastuzumab + chemotherapy: 

• Median OS: 22.9 vs 19.6 months
• HR 0.76 (95% CI 0.62–0.93; P=0.0088)

  Zanidatamab + tislelizumab + chemotherapy achieved the longest median OS: 

• 27.0 months vs 22.9 months with zanidatamab + chemotherapy
• HR 0.81 (95% CI 0.65–1.00; P=0.0502), not statistically significant

  OS benefit of zanidatamab + tislelizumab + chemotherapy versus trastuzumab + chemotherapy was maintained and strengthened: 

• HR improved from 0.72 at first interim analysis to 0.65 (95% CI 0.52–0.80)

  Estimated 36-month OS rates: 

• 39.8% with zanidatamab + tislelizumab + chemotherapy
• 31.5% with zanidatamab + chemotherapy
• 22.9% with trastuzumab + chemotherapy

  Median treatment duration: 

• 46.6 weeks with zanidatamab + tislelizumab + chemotherapy
• 31.1 weeks with zanidatamab + chemotherapy
• 30.0 weeks with trastuzumab + chemotherapy

  Safety profiles remained consistent with the first interim analysis, with no new safety signals reported.

Conclusion

With longer follow-up, zanidatamab plus chemotherapy demonstrated a significant OS advantage over trastuzumab plus chemotherapy. Adding tislelizumab further strengthened the OS benefit versus trastuzumab-based treatment and showed a favourable, but not statistically significant, trend versus zanidatamab plus chemotherapy. Safety remained consistent.

Reference 

Shitara K. Zanidatamab (zani) + chemotherapy (CT) ± tislelizumab (TIS) for first-line (1L) HER2-positive (HER2+) advanced/metastatic gastroesophageal adenocarcinoma (mGEA): Second interim analysis (IA) from HERIZON-GEA-01, LBA79. Paper presented at: ESMO Congress 2026; October 23–27, 2026; Madrid, Spain

LBA80 - Anbenitamab Plus Chemotherapy for Previously Treated HER2-Positive Gastric or Gastroesophageal Carcinomas (GC/GEJC): Updated Overall Survival (OS) Analysis of KC-WISE

Presenter: Ruixing Zhang

Background

In the prespecified interim PFS analysis of KC-WISE, anbenitamab plus chemotherapy improved PFS and OS versus standard of care in patients with HER2-positive gastric or gastroesophageal junction carcinoma that had progressed after trastuzumab-containing treatment. This report provides the final PFS analysis and an interim OS analysis.

Aim

To assess updated OS and PFS outcomes with anbenitamab plus chemotherapy compared with control treatment.

Methods

• Patients with centrally confirmed HER2-positive gastric or gastroesophageal junction carcinoma after failure of trastuzumab-containing therapy were randomised to anbenitamab or placebo, each combined with standard-of-care chemotherapy. 
• A prespecified interim OS analysis, a co-primary endpoint, was planned after approximately 150 deaths. Data cutoff was 15 July 2026.

Results

  246 patients were randomized: anbenitamab (n=125) vs control (n=121). 

  Median follow-up: 22.8 months with anbenitamab and 22.3 months with control. 

  Overall survival (OS) was significantly improved with anbenitamab: 

• Median OS: 19.6 vs 9.6 months
• HR 0.39 (95% CI 0.28–0.54; P<0.0001)

  OS benefit was consistent across all prespecified subgroups. 

  Progression-free survival (PFS) was significantly prolonged: 

• Median PFS: 7.1 vs 2.7 months
• HR 0.35 (95% CI 0.26–0.48; P<0.0001)

  Investigator-assessed PFS results were consistent with IRC assessment. 

  Deaths: 66 (52.8%) in the anbenitamab arm vs 91 (75.2%) in the control arm. 

  Grade ≥3 treatment-related adverse events (TRAEs): 69.4% vs 47.9%. 

  Most common Grade ≥3 TRAEs: 

• Neutropenia: 33.1% vs 24.8%
• Leukopenia: 27.4% vs 25.6%
• Anemia: 24.2% vs 12.4%

  No treatment-related deaths occurred with anbenitamab, compared with 5 treatment-related deaths in the control arm.

Conclusion

For HER2-positive gastric or gastroesophageal junction carcinoma after trastuzumab failure, adding anbenitamab to chemotherapy significantly prolonged OS compared with standard of care, with IRC-assessed PFS results showing a consistent benefit.

Reference 

Zhang R. Anbenitamab plus chemotherapy for previously treated HER2-positive gastric or gastroesophageal carcinomas (GC/GEJC): Updated overall survival (OS) analysis of KC-WISE, LBA80. Paper presented at: ESMO Congress 2026; October 23–27, 2026; Madrid, Spain

LBA39 - First results from the randomised ENGOT-OV56/NSGO-CTU-DOVACC trial investigating olaparib (ola), durvalumab (durva) and UV1 vaccination as maintenance therapy for patients (pts) with BRCA-wildtype (wt) recurrent ovarian cancer (ROC)

Presenter: Trine Jakobi Nøttrup

Background

UV1 is a therapeutic cancer vaccine targeting human telomerase reverse transcriptase (hTERT). The DOVACC study investigated whether UV1-mediated immune activation could improve olaparib maintenance, with or without durvalumab, in BRCA-wildtype recurrent ovarian cancer.

Aim

To evaluate the efficacy of olaparib-based maintenance regimens with UV1 vaccination, with or without durvalumab, in this population.

Methods

• This open-label, randomised phase 2 trial enrolled patients with non-germline BRCA-mutated or tumour BRCA-wildtype disease who had completed 2–3 prior chemotherapy lines without progression on or after their latest platinum-based regimen.
• Prior PARP inhibitor therapy was permitted if given for >6 months without progression; prior immunotherapy was not allowed. 
• Patients were randomised 1:1:2 to olaparib maintenance (Arm A), olaparib plus durvalumab (Arm B), or olaparib plus durvalumab and UV1 (Arm C).

Results

  188 patients were randomized: Arm A (n=46), Arm B (n=48), and Arm C (n=94). 

  82% were PARP inhibitor-naïve and 73% had HRD-negative tumors. 

  Median follow-up: 22.6 months (95% CI 19.5–28.1). 

  Primary comparison (Arm C vs Arm A): 

• Median PFS: 8.7 vs 5.9 months
• PFS events: 68% vs 74%
• HR 0.83 (95% CI 0.68–1.01; p=0.066)

  Post hoc analysis: 

• Restricted mean survival time difference at 22 months: +2.5 months
• 95% CI 0.1–4.9; exploratory p=0.043

  Arm C vs Arm B: 

• PFS HR 0.77 (95% CI 0.51–1.14)

  HRD-positive subgroup (n=36): 

• PFS events: 67% vs 50%
• HR 1.19 (95% CI 0.74–1.89)

  HRD-negative subgroup (n=104): 

• PFS events: 69% vs 82%
• HR 0.73 (95% CI 0.58–0.92)

  Prior PARP inhibitor subgroup (n=24): 

• PFS events: 88% vs 63%
• HR 0.95 (95% CI 0.58–1.54)

  PARP inhibitor-naïve subgroup (n=116): 

• PFS events: 64% vs 76%
• HR 0.81 (95% CI 0.65–1.01)

  Across all treatment arms, PFS was significantly better in PARP inhibitor-naïve patients than in PARP inhibitor-pretreated patients.

Conclusion

In BRCA-wildtype recurrent ovarian cancer, adding UV1 to PARP inhibitor maintenance, with or without durvalumab, did not significantly improve PFS at the two-sided 0.05 level. Signals in HRD-negative and PARP inhibitor-naïve subgroups warrant further investigation.

Reference 

Jakobi Nøttrup T. First results from the randomised ENGOT-OV56/NSGO-CTU-DOVACC trial investigating olaparib (ola), durvalumab (durva) and UV1 vaccination as maintenance therapy for patients (pts) with BRCA-wildtype (wt) recurrent ovarian cancer (ROC), LBA39. Paper presented at: ESMO Congress 2026; October 23–27, 2026; Madrid, Spain

ESMO Congress 2026, 23 - 27 October 2026, Madrid.