ESMO 2025 : Additional Highlights

 

Additional Highlights from ESMO 2025



Head and neck cancer 

  • Subcutaneous amivantamab (OrigAMI‑4) in recurrent/metastatic HNSCC post‑PD‑1 and chemotherapy showed encouraging activity and tolerability, supporting a phase III OrigAMI‑5 trial of amivantamab + pembrolizumab + chemotherapy in HPV‑unrelated disease.clinicaltrialsarena
  • Early data suggest PD‑1–based perioperative combinations beyond pembrolizumab, including camrelizumab + chemotherapy regimens, may broaden neoadjuvant options in locally advanced HNSCC.dpsoncology.blogspot

Upper GI / gastric–GEJ 

  • SHR‑1701, a bifunctional PD‑L1/TGF‑β fusion protein, plus CAPOX significantly prolonged overall survival vs CAPOX alone in high‑risk gastric/GEJ cancer, with particular benefit in liver metastases and diffuse‑type histology.dailyreporter.esmo
  • Claudin 18.2‑targeted agents such as givastomig (CLDN18.2‑directed immunomodulatory antibody) combined with chemo‑immunotherapy achieved objective response rates above 70% in CLDN18.2‑positive, PD‑L1‑enriched gastric/GEJ cohorts, without dose‑limiting toxicities.oncodaily

Hepatobiliary 

  • MORPHEUS‑Liver: the triplet of tiragolumab + atezolizumab + bevacizumab increased objective response to about 40% in unresectable HCC in early‑phase work, although this was not confirmed in the negative SKYSCRAPER‑14 phase III trial.oncodaily+1
  • Irpagratinib (FGFR4 inhibitor) + atezolizumab produced response rates around 50–70% in biomarker‑selected, FGF19‑positive HCC, a subset that accounts for roughly one‑third of patients, illustrating the impact of molecular stratification.oncodaily

Genitourinary oncology 

  • Durvalumab + BCG from POTOMAC has stimulated exploration of other IO + intravesical combinations in high‑risk NMIBC, with several phase II studies underway testing alternative PD‑(L)1 partners and schedules.urologytimes
  • RNA‑defined “cluster‑based” strategies in RCC (e.g., OPTIC‑style approaches) are being used to match cabozantinib + nivolumab and other IO–TKI combinations to specific transcriptional phenotypes, moving RCC toward more granular precision medicine.oncodaily
  • Nephron‑sparing systemic approaches such as disitamab vedotin + tislelizumab in upper tract urothelial carcinoma aim to delay or avoid radical nephroureterectomy while maintaining oncologic control; early data support ongoing phase II/III development.oncodaily

Cellular therapies and next‑generation IO 

  • IMA203CD8, a next‑generation PRAME‑directed TCR T‑cell product, delivered an objective response rate of ~46% and disease control of ~84% across heavily pre‑treated PRAME‑positive solid tumours, with durable responses (>1 year median duration) in melanoma, ovarian cancer, and synovial sarcoma.finance.yahoo+1
  • Toxicity with IMA203CD8 was dominated by expected lymphodepletion‑related cytopenias and mostly low‑grade cytokine release syndrome, with no treatment‑related deaths, supporting progression to phase II dose‑expansion.finance.yahoo

Broader immunotherapy/combo trends

  • Bispecific and bifunctional antibodies such as ivonescimab (PD‑1/VEGF) and SHR‑1701 (PD‑L1/TGF‑β) are maturing into phase II/III trials, aiming to out‑perform classical PD‑1 + VEGF or PD‑L1 + chemotherapy backbones.apices+1
  • Novel CTLA‑4 + PD‑1 combinations (e.g., botensilimab + balstilimab) have delivered approximately 39% two‑year survival in highly pre‑treated, checkpoint‑refractory solid tumours, indicating potential tumour‑agnostic activity.apices
  • In SCLC, chemo‑immunotherapy followed by durvalumab + ceralasertib achieved high response (≈70%) and encouraging 1‑ and 2‑year survival, prompting interest in DNA‑damage response–IO combinations in other “immune‑cold” tumours.bigtencrc

AI, biomarkers and trial‑design directions

  • ESMO’s first position statements on AI‑based biomarkers and the ELCAP consensus on large language models outline quality criteria, validation principles, and guardrails for integrating AI into clinical decision‑making and trial workflows.dailyreporter.esmo
  • Early ctDNA work beyond bladder cancer suggested that current assay sensitivity in some tumour types (e.g., colon) may be insufficient for routine de‑escalation, highlighting the need for technical refinement and tumour‑specific thresholds.dailyreporter.esmo
  • Detailed analyses of MSI‑H/MMRd tumours showed that Lynch‑syndrome–associated cancers achieve the longest‑lasting immunotherapy benefit, and that tumour type and underlying genetic mechanism both shape response, going beyond a simple “MSI‑H = IO‑sensitive” paradigm.mskcc

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