Our conference coverage featured updates on clinical trials testing new treatments for NSCLC, bladder cancer, and breast cancer.
Highlights of the conference coverage from the 2025 European Society of Medical Oncology (ESMO) Congress included content on the efficacy of treatments for different forms of cancer, including the efficacy of treatments for non–small cell lung cancer (NSCLC), early breast cancer, prostate cancer, and bladder cancer.
Here are the highlights from ESMO 2025.
5. Abemaciclib Plus Endocrine Therapy Improves Overall Survival in High-Risk Early Breast Cancer
Phase 3 results of the monarchE trial (NCT03155997)—presented as an oral abstract at the 2025 ESMO Congress—found that those who received adjuvant abemaciclib (Verzenio; Eli Lilly) with endocrine therapy had prolonged overall survival, distant relapse-free survival, and invasive disease-free survival in patients who had hormone receptor–positive, HER2-negative, node-positive, early breast cancer. The trial evaluated the efficacy of abemaciclib in 5637 patients recruited between July 2017 and August 2019. The patients received 5 years of endocrine therapy with or without 2 years of abemaciclib. Overall survival rates were 86.8% in the abemaciclib arm vs 85.0% in the endocrine therapy arm after 84 months.
4. After Narrow Miss in Phase 3 Study, IO Biotech Ponders Next Steps for Immune-Modulatory, Off-the-Shelf Cancer Vaccine
IO Biotech revealed results during the 2025 ESMO Congress that showed that they narrowly missed statistical significance for progression-free survival in a phase 3 trial for their immune-modulatory cancer vaccine, Cylembio, combined with pembrolizumab (Keytruda; Merck). This would be used to treat previously untreated advanced melanoma. The vaccine had previously had promising results in a phase 1/2 trial that found an objective response rate of 80% in a study population of 30 patients. However, despite not meeting statistical significance in the phase 3 trial, the median progression-free survival showed promising results at 19.4 months vs 11.0 months in pembrolizumab alone.
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3. Enfortumab Vedotin Plus Pembro Cuts Risk of Disease Progression, Death 60% for Patients With MIBC Who Can’t Have Chemo With Bladder Removal
Patients diagnosed with muscle-invasive bladder cancer (MIBC) who cannot or choose not to have cisplatin-based chemotherapy to supplement their surgery to remove the bladder ultimately cut their risk of death or disease progression by 60% when they used enfortumab vedotin and pembrolizumab alongside surgery, according to results from the phase 3 EV-303/KEYNOTE-905 trial (NCT03924895). Overall survival was 50% higher in those who used enfortumab vedotin plus pembrolizumab compared with those who only had surgery. Median event-free survival was not reached for patients using the combination therapy compared with 15.7 months in those who only had the surgery. These results were calculated after 25 months of the trial.
2. Adding Radioligand Therapy Pluvicto to SOC Cuts Risk of Prostate Cancer Progression or Death 28%, but How Many Doses?
The risk of progression or death was reduced by 28% for patients with prostate-specific membrane antigen-positive metastatic hormone-sensitive prostate cancer when they received a combination of radioligand therapy lutetium vipivotide tetraxetan (Lu-PSMA-617) with androgen deprivation therapy and an androgen receptor pathway inhibitor. The patients tested for this trial were treatment-naïve or had been minimally treated in the past. The treatment arm had a higher objective response rate (85.3%) compared with androgen deprivation therapy and androgen receptor pathway inhibitors alone (80.8%). There was a positive trend in overall survival in the treatment arm, but the data were not mature as of the time of the article.
1. First-Line Zongertinib Yields Strong Responses in Patients With Advanced HER2-Mutant NSCLC
Results from the phase 1b trial, Beamion LUNG-1 (NCT04886804), showed that the tyrosine kinase inhibitor zongertinib had some potency as a first-line treatment in patients previously treated for advanced HER2-mutant NSCLC. There were 74 patients who received zongertinib. The objective response rate was 77%, of which 8% had a complete response and 69% had a partial response. A total of 80% had a response after 6 months of treatment, and progression-free survival was 79%. A total of 91% of the patients reported adverse events related to treatment, with no grade 4 or 5 adverse events; 18% of the patients had grade 3 adverse events. Diarrhea was the most common adverse event (54%).
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