ESMO Congress 2025 Highlights

This year, ESMO celebrated its 50th anniversary with a focus on education, collaboration, and advancing cancer care. Nearly 34,000 participants from 149 countries attended the annual congress in Berlin (17-21 October 2025)¹. In her opening speech, ESMO President Dr. Solange Peters outlined a forward-looking roadmap to re-engineer cancer care across the patient journey, grounded in five pillars: new drugs, treatment strategies, care delivery, toxicity management, and prevention².

Ready to dive in? Let's start with the 5 key highlights that stole the show.

1. ADCs Advance into Early-Stage Settings, Expanding Curative Potential

Antibody-drug conjugates (ADCs) dominated discussions, with data supporting their shift from metastatic to adjuvant use, aligning with the roadmap's focus on new drugs and de-escalation to reduce long-term toxicity. For HER2-positive early breast cancer, the DESTINY-Breast05 trial demonstrated that trastuzumab deruxtecan (T-DXd) improved invasive disease-free survival compared to trastuzumab emtansine (T-DM1), with a manageable safety profile that positions it as a potential new standard.³

For triple-negative breast cancer (TNBC), first-line sacituzumab govitecan ( Trodelvy^®) and datopotamab deruxtecan (Datroway®) met PFS endpoints in phase 3 trials (ASCENT-04 and TROPION-Breast01, respectively), showing survival benefits in PD-L1-negative patients ineligible for immunotherapy.⁴

Implications for Developers: These results highlight opportunities to prioritize ADC payloads with optimized linkers for reduced off-target effects, alongside co-development of companion diagnostics for antigens like TROP2 and HER2-low. Early-stage trials could accelerate regulatory pathways, but real-world evidence on reimbursement models and access will be critical for global equity.⁵.

2. Targeted Therapies Solidify Frontline Roles in Lung Cancer

Lung cancer sessions reinforced targeted agents' dominance, with overall survival (OS) data validating their integration into care delivery infrastructures. In anaplastic lymphoma kinase (ALK)-positive advanced NSCLC, final ALEX trial results confirmed alectinib's OS benefit (median 81.1 months vs. 54.2 for crizotinib), establishing it as a frontline standard-of-care.^6,7 Adjuvant osimertinib in EGFR-mutated resected NSCLC (ADAURA) reduced disease-free survival risks across mutations, while tarlatamab monotherapy extended OS (HR 0.62) in relapsed SCLC.^8,9

Implications for Developers: These outcomes signal a need for head-to-head trials against established TKIs and bispecific monoclonal antibodies, with emphasis on CNS penetration and resistance mechanisms. Collaborations for pan-mutation panels could address testing gaps, aligning with ESMO's call for early genomic characterization of biosamples to identify oncogene-addicted disease.¹⁰

3. Adjuvant CDK4/6 Inhibitors Confirm Broader Breast Cancer Benefits

Breast cancer data highlighted personalization, from neoadjuvant to metastatic settings, tying into prevention and post-remission care.¹¹ Neoadjuvant pembrolizumab plus chemotherapy (KEYNOTE-522) reduced event-free survival risks by 37% in early TNBC, increasing pathologic complete responses.^12,13 In HR+/HER2- advanced disease, capivasertib plus fulvestrant extended PFS in AKT-altered tumors (CAPItello-291), supporting biomarker enrichment.¹⁴

Implications for Developers: Opportunities lie in testing dual-targeting ADCs and CDK4/6 inhibitors with shorter treatment durations with a view on access and sustainability. Developers should consider investing in multiomic profiling to identify novel subsets, facilitating adaptive trials and partnerships with health economists for value frameworks.¹⁵

4. ctDNA and AI Biomarkers Drive Precision Across Tumor Types

Precision oncology sessions positioned ctDNA as a tool for minimal residual disease (MRD) detection and treatment intensification. In stage III colorectal cancer, ctDNA clearance post-adjuvant therapy predicted relapse-free survival (P<0.0001), with multi-test strategies enhancing sensitivity.¹⁶ For muscle-invasive bladder cancer (MIBC), IMvigor011 used ctDNA to guide adjuvant nivolumab, filling gaps post-cystectomy.¹⁷ AI-based biomarkers provided early insights into immunotherapy responses via multiomic integration.¹⁸

Implications for Developers: Embedding ctDNA in trial endpoints or to guide therapy changes could de-risk adjuvant programs and enable real-time adaptations. Cross-sector alliances for low-resource assays are essential to scale access, supporting ESMO's equity goals and accelerating liquid biopsy co-development.19

5. Relapsed Disease Strategies Prioritize Quality-of-Life and Access

In relapsed settings, combinations balanced efficacy with tolerability. Platinum-resistant ovarian cancer benefited from pembrolizumab plus chemotherapy (HR 0.75 PFS),²⁰ while gastric/esophageal squamous cell carcinoma saw OS gains with tislelizumab plus chemo (RATIONALE 306).²¹ Neoadjuvant nivolumab plus ipilimumab in high-risk muscle-invasive bladder cancer (MIBC) improved event-free survival.²²

Implications for Developers: Emphasize patient-reported outcomes in late-line trials to inform de-escalation.²³ New reimbursement models, as advocated in the roadmap, could facilitate uptake in diverse geographies.

Whether you’re advancing ADCs, immunotherapies, targeted agents, or digital health solutions, Fortrea is your partner for navigating complexity and maximizing impact.

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Connect with us to explore how Fortrea can support your next oncology innovation—from first-in-human to post-approval and beyond. https://www.fortrea.com/therapeutics/oncology

Note: The views expressed are based on publicly available data and do not represent sponsor-specific recommendations or commitments.

References:

1. https://www.esmo.org/meeting-calendar/esmo-congress-2025/industry-participation
2. https://dailyreporter.esmo.org/esmo-congress-2025/editorial/optimising-cancer-care-for-individual-patients-is-key-to-improving-outcomes-for-all
3. https://www.esmo.org/press-releases/new-generation-of-antibody-drug-conjugates-adcs-shows-unprecedented-promise-in-early-stage-disease
4. https://dailyreporter.esmo.org/esmo-congress-2025/breast-cancer/survival-improvements-observed-with-first-line-antibody-drug-conjugates-in-triple-negative-breast-cancer
5. https://www.fiercebiotech.com/biotech/esmo-adc-rollercoaster-rides
6. https://www.annalsofoncology.org/article/S0923-7534(25)04788-X/fulltext
7. https://oncologypro.esmo.org/video-series/alex-final-os-data-from-alectinib-versus-crizotinib-for-previously-untreated-advanced-alk-nsclc
8. https://www.lungcancerstoday.com/post/adaura-trial-findings-osimertinib-for-egfr-mutated-nsclc
9. https://www.esmo.org/oncology-news/tarlatamab-prolongs-os-over-chemotherapy-among-patients-with-sclc-whose-disease-had-progressed-during-or-after-platinum-based-chemotherapy
10. https://www.esmo.org/guidelines/living-guidelines/esmo-living-guideline-non-oncogene-addicted-metastatic-non-small-cell-lung-cancer/management-with-systemic-therapy/non-squamous-non-small-cell-carcinoma-without-contraindication-for-immunotherapy
11. https://onco-hema.healthbooktimes.org/article/145278-treatment-options-for-hr-positive-her2-negative-advanced-breast-cancer-focus-on-capivasertib
12. https://www.nejm.org/doi/full/10.1056/NEJMoa2112651
13. https://www.esmo.org/oncology-news/neoadjuvant-pembrolizumab-plus-chemotherapy-followed-by-adjuvant-pembrolizumab-prolongs-os-among-patients-with-early-stage-tnbc
14. https://www.nature.com/articles/s41467-025-59210-6
15. https://www.onclive.com/view/breast-cancer-experts-key-adc-developments-and-cdk-4-6-inhibitor-updates-set-to-dominate-esmo-2025
16. https://pmc.ncbi.nlm.nih.gov/articles/PMC12186373/
17. https://dailyreporter.esmo.org/esmo-congress-2025/genitourinary-cancers/first-trial-evidence-supports-minimal-residual-disease-guided-adjuvant-immunotherapy-in-bladder-cancer
18. https://dailyreporter.esmo.org/esmo-congress-2025/ai-digital-oncology/new-artificial-intelligence-based-biomarkers-offer-early-insight-into-treatment-response
19. https://institut-curie.org/esmo2025
20. https://www.cancernetwork.com/view/pembrolizumab-combo-significantly-improves-pfs-os-in-recurrent-proc
21. https://www.annalsofoncology.org/article/S0923-7534(25)00608-8/fulltext
22. https://www.esmo.org/oncology-news/neoadjuvant-nivolumab-plus-ipilimumab-shows-trend-towards-long-term-clinical-benefit-versus-chemotherapy-in-patients-with-resectable-nsclc
23. https://dailyreporter.esmo.org/esmo-targeted-anticancer-therapies-asia-congress-2025/news/patient-reported-outcomes-in-dose-finding-show-value-in-oncology-trial-inclusion-but-shared-standards-are-needed

Featured Presentation

Title: Capivasertib plus fulvestrant as first- and second-line endocrine-based therapy in PIK3CA/AKT1/PTEN-altered hormone receptor-positive advanced breast cancer: Subgroup analysis from the Phase 3 CAPItello-291 trial