Highlights of ASCO 2025
Videocast SBM-SP
Dr. Lincon Jo Mori
Coordenador da Comissão de Educação Continuada │SBM-SP
Dr. Leonardo Orlandini
Comissão de Educação Continuada │SBM-SP
Dr. Carlos Barrios
Presidente do LACOG e Coordenador de Pesquisa Hospital São Lucas │ PUC-RS
Dr. Franklin Pimentel
Coordenador da Comissão de Tratamento Sistêmico da SBM-SP
Dr. Ruffo de Freitas
Professor Associado Universidade Federal de Goias
ASCO Annual Meeting 2025
ASCO Annual Meeting 2025
Tópicos
ASCO Annual Meeting 2025
<br />Efficacy and safety of elinzanetant for vasomotor symptoms associated with endocrine therapy: Phase III OASIS-4 trial
ASCO Annual Meeting 2025
Key takeaway points
Cardoso F ASCO 2025
ASCO Annual Meeting 2025
Results – Mean change from baseline in average daily moderate-to-severe VMS frequency over time
Cardoso F ASCO 2025
Cardoso F ASCO 2025
ASCO Annual Meeting 2025
Conclusions
Cardoso F ASCO 2025
ASCO Annual Meeting 2025
Slide 17
ASCO Annual Meeting 2025
What this study means for patients
Cardoso F ASCO 2025
ASCO Annual Meeting 2025
ASCO Annual Meeting 2025
ASCO Annual Meeting 2025
Agrawal L ASCO 2025
ASCO Annual Meeting 2025
Agrawal L ASCO 2025
ASCO Annual Meeting 2025
Agrawal L ASCO 2025
ASCO Annual Meeting 2025
De-escalated neoadjuvant taxane plus trastuzumab and pertuzumab with or without carboplatin in HER2-positive early breast cancer (neoCARHP): A multicentre, open-label, randomised, phase 3 trial
ASCO Annual Meeting 2025
Background
Wang K ASCO 2025
ASCO Annual Meeting 2025
neoCARHP Study Design (NCT04858529)
Wang K L ASCO 2025
ASCO Annual Meeting 2025
Baseline Patients Characteristics
Wang K ASCO 2025
ASCO Annual Meeting 2025
Efficacy Analysis: pCR
Wang K L ASCO 2025
ASCO Annual Meeting 2025
Efficacy Analysis: pCR by hormone receptor status
Wang K ASCO 2025
ASCO Annual Meeting 2025
Efficacy Analysis: pCR by Subgroup
Wang K ASCO 2025
ASCO Annual Meeting 2025
Clinical response during neoadjuvant therapy
Wang K ASCO 2025
ASCO Annual Meeting 2025
Grade ≥ 3 hematological adverse events
Wang K ASCO 2025
ASCO Annual Meeting 2025
Frequent non-hematological adverse events
Wang K ASCO 2025
ASCO Annual Meeting 2025
Conclusions
Wang K ASCO 2025
ASCO Annual Meeting 2025
Trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane <br />+ trastuzumab + pertuzumab (THP) for first-line treatment <br />of patients with human epidermal growth factor <br />receptor 2–positive (HER2+) advanced/metastatic<br />breast cancer: interim results from DESTINY-Breast09
ASCO Annual Meeting 2025
Key takeaways
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
Evolution of T-DXd in HER2+ a/mBC
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
DESTINY-Breast09 study design
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
Patient demographics and key baseline characteristics
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
Prior therapies
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
PFS (BICR): primary endpoint
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
PFS (investigator assessment)
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
PFS (BICR): subgroup analyses
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
ORR and DOR (BICR)
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
Overall survival (~16% maturity)
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
PFS2 (investigator assessment) and post-trial treatments
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
Overall safety summary
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
Conclusions
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
First Line Therapy for HER2+ MBC:<br />A New Treatment Paradigm?
ASCO Annual Meeting 2025
Key Takeaway Points – Destiny Breast09 Trial
Isaacs C ASCO 2025
ASCO Annual Meeting 2025
1L HR+/HER2+ mBC: PATINA Trial
Isaacs C ASCO 2025
ASCO Annual Meeting 2025
1L HER2+ Metastatic Breast Cancer: CLEOPATRA<br />End-of-Study Analysis
Isaacs C ASCO 2025
ASCO Annual Meeting 2025
DESTINY-Breast09 – 1L HER2+ mBC
Isaacs C ASCO 2025
ASCO Annual Meeting 2025
DESTINY-Breast09 – 1L HER2+ mBC
Isaacs C ASCO 2025
ASCO Annual Meeting 2025
DB-09: Toxicity
Isaacs C ASCO 2025
ASCO Annual Meeting 2025
Slide 9
Isaacs C ASCO 2025
ASCO Annual Meeting 2025
Sequencing- T-DXd First Line or Second Line?<br />PFS2 Data from DB-09
Isaacs C ASCO 2025
ASCO Annual Meeting 2025
How do we integrate these data in our treatment algorithm?
Isaacs C ASCO 2025
ASCO Annual Meeting 2025
How Do We Best Sequence HER2 Directed Therapy?
ASCO Annual Meeting 2025
How Do We Best Sequence HER2 Directed Therapy?<br />Markers of response
ASCO Annual Meeting 2025
How Do We Best Sequence HER2 Directed Therapy?
ASCO Annual Meeting 2025
Duration of Therapy with T-DXd
ASCO Annual Meeting 2025
ASCO Annual Meeting 2025
Summary:
Isaacs C ASCO 2025
ASCO Annual Meeting 2025
Camizestrant + CDK4/6 inhibitor for the treatment of emergent ESR1 mutations during first-line endocrine-based therapy and ahead of disease progression in patients with HR+/HER2– advanced breast cancer: <br />Phase 3, double-blind ctDNA-guided SERENA-6 trial
ASCO Annual Meeting 2025
Background
Turner N ASCO 2025
ASCO Annual Meeting 2025
Background to the SERENA-6 study
ASCO Annual Meeting 2025
ESR1m surveillance during first-line AI+CDK4/6i
Turner N ASCO 2025
ASCO Annual Meeting 2025
SERENA-6 study design
Turner N ASCO 2025
ASCO Annual Meeting 2025
Baseline characteristics
Turner N ASCO 2025
ASCO Annual Meeting 2025
Primary endpoint: Investigator-assessed PFS
Turner N ASCO 2025
ASCO Annual Meeting 2025
Investigator-assessed PFS by subgroup
Turner N ASCO 2025
ASCO Annual Meeting 2025
Time to deterioration in global health status/quality of life<br />EORTC QLQ-C30
Turner N ASCO 2025
ASCO Annual Meeting 2025
Second progression-free survival (PFS2)<br />Key secondary endpoint
Turner N ASCO 2025
ASCO Annual Meeting 2025
Safety summary
Turner N ASCO 2025
ASCO Annual Meeting 2025
Adverse events (≥10% of patients)
Turner N ASCO 2025
ASCO Annual Meeting 2025
Conclusions
Turner N ASCO 2025
ASCO Annual Meeting 2025
ASCO Annual Meeting 2025
Acknowledgments
ASCO Annual Meeting 2025
Attacking resistance at its earliest sign:<br /> Can we improve outcomes in ER+ metastatic breast cancer?
ASCO Annual Meeting 2025
Key Take Aways: SERENA-6
DeMichele A ASCO 2025
ASCO Annual Meeting 2025
PFS for SERDS in 2nd line ESR1m ER+ MBC
DeMichele A ASCO 2025
ASCO Annual Meeting 2025
SERENA-6 hypotheses and rationale
DeMichele A ASCO 2025
ASCO Annual Meeting 2025
SERENA-6 met primary endpoint
DeMichele A ASCO 2025
ASCO Annual Meeting 2025
SERENA-6: Study Strengths
DeMichele A ASCO 2025
ASCO Annual Meeting 2025
SERENA-6 PFS: Unanswered questions
DeMichele A ASCO 2025
ASCO Annual Meeting 2025
Defining “Clinical Utility”
DeMichele A ASCO 2025
ASCO Annual Meeting 2025
Overall survival and PFS-2
ASCO Annual Meeting 2025
PFS-2 in SERENA-6
DeMichele A ASCO 2025
ASCO Annual Meeting 2025
Other issues that could impede determination of clinical utility
ASCO Annual Meeting 2025
Lack of crossover limits clinical utility assessment
DeMichele A ASCO 2025
ASCO Annual Meeting 2025
Imbalance in post-progression treatment
DeMichele A ASCO 2025
ASCO Annual Meeting 2025
Slide 18
DeMichele A ASCO 2025
ASCO Annual Meeting 2025
Serial ctDNA screening for mutations is a big lift
DeMichele A ASCO 2025
ASCO Annual Meeting 2025
QOL and costs during testing phase
ASCO Annual Meeting 2025
Key Take Aways from SERENA-6
DeMichele A ASCO 2025
ASCO Annual Meeting 2025
How to counsel patient ?
DeMichele A ASCO 2025
ASCO Annual Meeting 2025
Sacituzumab Govitecan Plus Pembrolizumab vs Chemotherapy Plus Pembrolizumab in Patients With Previously Untreated, <br />PD-L1 Positive, Advanced or Metastatic Triple-Negative Breast Cancer: Primary Results From the Randomized, Phase 3 ASCENT-04/KEYNOTE-D19 Study
ASCO Annual Meeting 2025
Key Takeaways: ASCENT-04/KEYNOTE-D19 Phase 3 Study
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
Unmet Need in Previously Untreated, PD-L1+, Locally Advanced Unresectable or Metastatic TNBC
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
ASCENT-04/KEYNOTE-D19 Study Design
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
Statistical Analysis
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
Demographics and Baseline Characteristics
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
Progression-Free Survival by BICR
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
Progression-Free Survival by Investigator Assessment
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
Subgroup Analysis of Progression-Free Survival by BICR
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
Slide 10
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
Tumor Responses and Duration of Response by BICR
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
Exposure and Safety Summary
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
Most Common Adverse Events (≥20% in any group)
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
Adverse Events of Special Interest
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
Conclusions
Tolaney SM ASCO 2025
ASCO Annual Meeting 2025
INAVO120 Phase III trial final overall survival (OS) analysis of first-line inavolisib (INAVO)/placebo (PBO) + palbociclib (PALBO) + <br />fulvestrant (FULV) in patients (pts) with PIK3CA-mutated, <br />hormone receptor-positive (HR+), HER2-negative (HER2–), <br />endocrine-resistant advanced breast cancer (aBC).
ASCO Annual Meeting 2025
Key takeaway points/conclusions
Turner N ASCO 2025
ASCO Annual Meeting 2025
Background
Turner N ASCO 2025
ASCO Annual Meeting 2025
INAVO120: A Phase III, randomized, double-blind, <br />placebo-controlled study1,2
Turner N ASCO 2025
ASCO Annual Meeting 2025
INAVO120 primary analysis results
Turner N ASCO 2025
ASCO Annual Meeting 2025
INAVO120 updated patient disposition
Turner N ASCO 2025
ASCO Annual Meeting 2025
INAVO120 updated PFS
Turner N ASCO 2025
ASCO Annual Meeting 2025
INAVO120 key secondary endpoint: OS
Turner N ASCO 2025
ASCO Annual Meeting 2025
INAVO120 OS in key subgroups (1/2)
Turner N ASCO 2025
ASCO Annual Meeting 2025
INAVO120 OS in key subgroups (2/2)
Turner N ASCO 2025
ASCO Annual Meeting 2025
INAVO120 key post-progression therapies
Turner N ASCO 2025
ASCO Annual Meeting 2025
INAVO120 other key secondary endpoints
Turner N ASCO 2025
ASCO Annual Meeting 2025
INAVO120 time to first subsequent chemotherapy
Turner N ASCO 2025
ASCO Annual Meeting 2025
INAVO120 overview of AEs
Turner N ASCO 2025
ASCO Annual Meeting 2025
INAVO120 selected AEs*
Turner N ASCO 2025
ASCO Annual Meeting 2025
INAVO120 limitations
Turner N ASCO 2025
ASCO Annual Meeting 2025
Key takeaway points/conclusions
Turner N ASCO 2025
ASCO Annual Meeting 2025
ASCO Annual Meeting 2025
Obrigado !
@sbmastologiasp
@sbmastologiaspcientifico
ASCO Annual Meeting 2025