News|Articles|October 16, 2025

ESMO 2025 Poll Results: Most Anticipated GU Cancer Abstracts

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Key Takeaways

  • RAMPART trial investigates adjuvant durvalumab, alone or with tremelimumab, for resected RCC, aiming to prevent or delay relapse.
  • KEYMAKER-U03 substudy evaluates multiple pembrolizumab-based regimens for first-line RCC, focusing on safety and efficacy.
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Discover the most anticipated abstracts on renal cell carcinoma and bladder cancer at the 2025 ESMO Congress in Berlin.

With the 2025 European Society of Medical Oncology (ESMO) Congress starting on Friday, October 17, in Berlin, Germany, Targeted Oncology is bringing you background on the most exciting abstracts across genitourinary (GU) cancers set to be presented.

Targeted Oncology conducted polls on X and LinkedIn to identify which renal cell carcinoma (RCC) and bladder cancer abstracts GU specialists were most anticipating. See the results of our polls below.

Poll 1: Which of these RCC abstracts are you most anticipating at ESMO 2025?

1. LBA93 - First results from RAMPART: An international phase 3 randomized-controlled trial of adjuvant durvalumab monotherapy or combined with tremelimumab for resected primary renal cell carcinoma (RCC) led by MRC CTU at UCL

2. LBA94 - LenCabo: A randomized phase II multicenter trial of lenvatinib plus everolimus (len/eve) versus (vs) cabozantinib (cabo) in patients (pts) with metastatic clear cell RCC (ccRCC) that progressed on PD-1 immune checkpoint inhibition (ICI)

3. LBA95 - Neoadjuvant immunotherapy in locally advanced clear cell renal cell carcinoma at risk for recurrence or distant metastases: the randomized phase II NESCIO trial

4. LBA96 - First-line pembrolizumab-based regimens for advanced clear cell renal cell carcinoma: KEYMAKER-U03 substudy 03A

Results were split, with 100% of X users voting for RAMPART (NCT03288532), while 58% on LinkedIn were most interested in the KEYMAKER-U03 substudy (NCT04626479).

RAMPART, or Renal Adjuvant MultiPle Arm Randomized Trial, is an international phase 3 multi-stage platform trial of adjuvant therapy in patients with resected primary RCC at high or intermediate risk of relapse.1 The trial is initially testing whether durvalumab (Imfinzi) alone or in combination with tremelimumab (Imjudo) prevents or delays cancer return vs the current standard of care, which is observation by clinical and radiological means. First results from RAMPART being presented at this year’s ESMO Congress.

The main KEYMAKER-U03 study is investigating immunotherapy and targeted drug combinations for the treatment of RCC. Substudy 03A is specifically evaluating several experimental arms in patients with first-line RCC.2 The arms include:

  • Coformulation of pembrolizumab (Keytruda)/quavonlimab and lenvatinib (Lenvima)
  • Coformulation favezelimab/pembrolizumab and lenvatinib
  • Pembrolizumab, belzutifan (Welireg), and lenvatinib
  • Pembrolizumab and lenvatinib
  • Coformulation viostolimab/pembrolizumab and belzutifan

In the safety lead-in phase, the primary end points are dose-limiting toxicities (DLTs), incidence of adverse events (AEs), and discontinuation due to AEs. In the efficacy phase, the primary end points are incidences of DLTs and AEs as well as overall response rate.

Presentation Details:

LBA93 (RAMPART): Saturday, October 18, at 9:20 am CEST

LBA96 (KEYMAKER-U03): Saturday, October 18, at 8:30 am CEST

Poll 2: Which of these bladder cancer abstracts are you most anticipating at ESMO 2025?

1. LBA107: ALBAN: A phase 3, randomized, open-label, international study of intravenous (IV) atezolizumab and intravesical Bacillus Calmette-Guérin (BCG) vs BCG alone in BCG-naive high-risk, non–muscle-invasive bladder cancer (NMIBC)

2. LBA108 - Durvalumab (D) in combination with BCG for BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): final analysis of the phase 3, open-label, randomized POTOMAC trial

3. LBA110 - A blinded, exploratory phase 2 trial of nivolumab and the GDF-15 neutralizing antibody visugromab or placebo as neoadjuvant treatment of patients with muscle-invasive bladder cancer (MIBC): Primary results of the GDFather-NEO trial

4. LBA112 - Neoadjuvant gemcitabine intravesical system (TAR-200) + cetrelimab (CET) or CET alone in patients (pts) with muscle-invasive bladder cancer (MIBC): SunRISe-4 (SR-4) primary analysis and biomarker results

POTOMAC (NCT03528694) was the winner on both X and LinkedIn, garnering 50% of the vote on each platform. The phase 3 study investigated durvalumab plus standard-of-care Bacillus Calmette-Guérin (BCG) induction and maintenance therapy in patients with high-risk non–muscle-invasive bladder cancer.3 The combination led to a statistically significant and clinically meaningful improvement in the primary end point of disease-free survival compared with BCG induction and maintenance alone. The final analysis of the study is expected at the ESMO Congress.

Presentation Details:

LBA108 (POTOMAC): Friday, October 17, at 2:10 PM CEST

REFERENCES:
1. RAMPART. MRC Clinical Trials Unit at UCL. Accessed October 14, 2025. https://www.mrcctu.ucl.ac.uk/our-research/cancer/rampart/
2. Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A). ClinicalTrials.gov. Updated February 17, 2025. Accessed October 14, 2025. https://clinicaltrials.gov/study/NCT04626479
3. Imfinzi regimen demonstrated statistically significant and clinically meaningful improvement in disease-free survival for high-risk non-muscle-invasive bladder cancer in POTOMAC phase III trial. News release. AstraZeneca. May 9, 2025. Accessed October 14, 2025. https://tinyurl.com/y6phhzhu

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