Amol Akhade, Senior Consultant at Fortis Hospitals Mumbai, shared a post on LinkedIn:
“ESMO 2025 Day 3 — Key Data Highlights – Minus Noise
Prostate Cancer
1. PSMAAddition – Lu-PSMA-617 plus ADT plus ARPI versus ADT plus ARPI in mHSPC
- rPFS HR 0.72 (95 % CI 0.58–0.90; p = 0.002) | OS HR 0.84 (95 % CI 0.63–1.13; immature) ORR 85 % versus 81 %
- My Take
Goal (‘live longer & better’) not met → Not for routine use
Restrict to PSMA-avid high-volume mHSPC in expert centres . Not A New SOC .
2. ENZARD – ADT plus RT plus/minus Enzalutamide in high-risk HSPC
- MFS HR 0.90 (95 % CI 0.68–1.18) | OS HR 1.02 (95 % CI 0.78–1.35) → negative
- Take: No benefit from Enza with RT; abiraterone remains preferred for node-positive cases.
3. EMBARK – ADT plus/minus Enzalutamide in biochemical recurrence
- 8-yr OS 78.9 % versus 69.5 % (HR 0.60) → about9 % absolute gain
- Take: Supports early intensification in high-risk BRPC.
4. CAPItello-281 – Abi plus ADT plus/minus Capivasertib (PTEN-deficient mHSPC)
- rPFS 33.2 versus 25.7 mo (HR 0.81) | OS immature AEs: rash 26 %, hyperglycaemia 17 %, diarrhea
- Take: Modest gain; AKT targeting still exploratory.
Lung Cancer
5. HARMONY-6 – Ivonescimab plus Chemo versus Tislelizumab plus Chemo (1L sq-NSCLC)
- mPFS 11.1 versus 6.9 mo (HR 0.60; 95 % CI 0.46–0.78; p < 0.0001) Benefit across PD-L1 subgroups (TPS < 1 % HR 0.55 | TPS ≥ 1 % HR 0.66)
OS immature | Safety manageable
- Take: Superior PFS independent of PD-L1
China 🇨🇳 only trial. contor arm is NOT SOC . Wait for OS .
6. OptiTROP-Lung04 (SAC-TMT) – Sacituzumab Tirumotecan versus Platinum Chemo in EGFR-mut NSCLC after TKI
- mPFS 8.3 versus 4.3 mo (HR 0.49; 95 % CI 0.39–0.62; p < 0.0001) .
- mOS NR versus 17.4 mo (HR 0.60; 95 % CI 0.44–0.82; p = 0.001)
- Take: First ADC with survival benefit . We don’t know how it will do Against Sub Cut Amivantanab.
Not Practice Changing . Need Global Trial .
Urothelial Cancer
7. RC48-C016 – Disitamab Vedotin plus Toripalimab versus Chemo (HER2 1L UC)
- PFS 13.1 versus 6.5 mo (HR 0.36) | OS 31.5 versus 16.9 mo (HR 0.54) ORR 76 % versus 50 % | G3plus AEs 55 % versus 87 %
- Take: Doubles PFS and OS → new SOC for HER2plus UC.
Breast Cancer
8.DESTINY-Breast09 – T-DXd in 1L HER2plus mBC
- mPFS 40.7 mo versus 26.9 mo (HR 0.56; p < 0.00001) and ORR 83 % versus 77 % with T-DXd plus Pertuzumab versus THP in 1L HER2-positive metastatic breast cancer.
- Cost and Long term toxicity is Issue .
9. ASCENT-03 – Sacituzumab Govitecan versus Chemo (1L PD-L1-neg TNBC)
- mPFS 9.7 versus 6.9 mo (HR 0.62; p < 0.0001) | OS improved (numeric) 6-mo PFS 65 % versus 53 % | 12-mo 41 % versus 24 %
- Take: New SOC for PD-L1-negative TNBC;
10. TROPION-Breast02 – Dato-DXd versus Chemo (1L PD-L1-ineligible TNBC)
- mPFS 10.8 versus 5.6 mo (HR 0.57) | mOS 23.7 versus 18.7 mo (HR 0.79) ORR 62 % versus 29 % | ILD about 5 %.
- Take: Superior efficacy with ILD risk → needs specialised monitoring.
Sarcoma
11.RAR-IMMUNE – Nivolumab plus Ipilimumab (1 mg/kg) versus Pazopanib in rare subtypes
- PFS/OS: negative | ORR: better in selected histotypes
- Take: No overall benefit; rare sarcomas remain unmet need.”
ESMO 2025 Day 1 Highlights Not to Miss
ESMO 2025 Day 2 Highlights Not to Miss