ESMO 2025: Highlights and analysis

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Published: 23 Oct 2025
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Assoc Prof Bishal Gyawali - Queen's University, Kingston, Canada

Long time ecancer contributor Dr Bishal Gyawali joins us again for his 10th ESMO roundup, marking a decade of casting his acerbic eye over the latest data. Several presentations on topics such as GI, lung, breast, melanoma and prostate are covered:

5-year follow-up results from the POSITIVE (Pregnancy Outcome and Safety of Interrupting Therapy for Women with Endocrine Responsive Breast Cancer) trial
monarchE: Primary overall survival (OS) results of adjuvant abemaciclib + endocrine therapy for HR+, HER2-, high-risk early breast cancer and adjuvant ribociclib plus nonsteroidal aromatase inhibitor in patients with HR+/HER2− early breast cancer: NATALEE 5-year outcomes
A phase II, randomized, open- labelled study to evaluate low-dose pembrolizumab in addition to neoadjuvant chemotherapy for triple-negative breast cancer (TNBC)
DESTINY-Breast11: Neoadjuvant trastuzumab deruxtecan alone (T-DXd) or followed by paclitaxel + trastuzumab + pertuzumab (T-DXd-THP) vs SOC for high-risk HER2+ early breast cancer (eBC)
Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients with high-risk human epidermal growth factor receptor 2–positive (HER2+) primary breast cancer with residual invasive disease after neoadjuvant therapy: Interim analysis of DESTINY-Breast05
Giredestrant, an oral selective oestrogen receptor antagonist and degrader, + everolimus in patients with ER-positive, HER2-negative advanced breast cancer previously treated with a CDK4/6 inhibitor (i): Primary results of the phase III evERA BC trial and Gedatolisib + fulvestrant ± palbociclib vs fulvestrant in patients with HR+/ HER2-/PIK3CA wild-type (WT) advanced breast cancer (ABC): First results from VIKTORIA-1
Primary results from ASCENT-03: A randomized phase III study of sacituzumab govitecan vs chemotherapy in patients with previously untreated advanced TNBC who are unable to receive PD-(L)1 inhibitors and first-line datopotamab deruxtecan vs chemotherapy in patients with locally recurrent inoperable or mTNBC for whom immunotherapy was not an option: Primary results from the randomised, phase III TROPION-Breast02 trial
Perioperative enfortumab vedotin plus pembrolizumab in participants with muscle-invasive bladder cancer who are cisplatin-ineligible: The phase III KEYNOTE-905 study
ALBAN: A phase III, randomized, open-label, international study of intravenous atezolizumab and intravesical Bacillus Calmette-Guérin vs BCG alone in BCG-naïve high-risk, non-muscle-invasive bladder cancer
Durvalumab in combination with Bacillus Calmette-Guérin (BCG) for BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC): Final analysis of the phase III, open-label, randomised POTOMAC trial
Phase III trial of [177Lu]Lu-PSMA-617 combined with ADT + ARPI in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (PSMAddition)
EMBARK: Overall survival with enzalutamide in biochemically recurrent prostate cancer
Pembrolizumab plus chemotherapy (PEM + CT) versus pembrolizumab (PEM) as first-line therapy for advanced NSCLC with PD-L1 tumor proportion score (TPS) ≥50%: Open-label, phase III, randomized trial (PAULIEN)
Sacituzumab tirumotecan (sac-TMT) vs platinum-based chemotherapy in EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) following progression on EGFR-TKIs: results from the randomized, multi-center phase III OptiTROP-Lung04 study
Disitamab vedotin (DV) plus toripalimab (T) versus chemotherapy (C) in first-line (1L) locally advanced or metastatic urothelial carcinoma (la/mUC) with HER2-expression
IMvigor011: A phase III trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer
ctDNA-guided adjuvant chemotherapy de-escalation in stage III colon cancer: Primary analysis of the ctDNA-negative cohort from the randomized AGITG DYNAMIC-III trial (Intergroup study of AGITG and CCTG)
Final overall survival and the association of pathological outcomes with event-free survival in MATTERHORN: A randomised, phase III study of durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel in resectable gastric / gastroesophageal junction adenocarcinoma
Zanzalintinib plus atezolizumab (zanza + atezo) vs regorafenib (rego) in patients (pts) with previously treated metastatic colorectal cancer (mCRC): Primary overall survival (OS) analysis from the randomized, open-label, phase III STELLAR-303 study
Final, 9-year results from the CheckMate 238 phase III trial of adjuvant nivolumab vs ipilimumab in resected stage IIIB–C or IV melanoma
Two-year clinical update and first biomarker analyses of the phase III NADINA trial comparing neoadjuvant nivolumab plus ipilimumab versus adjuvant nivolumab in resectable stage III melanoma
Final results of the RAR-IMMUNE study: A randomized, comparative, prospective, multicenter phase III trial of the efficacy of nivolumab + ipilimumab (N+I) versus pazopanib (P) in patients (pt) with advanced sarcoma (S) of rare subtype