ASCO 2025 | Friday, May 30 Daily Highlights
Artificial Intelligence in Oncology: Promise and Progress
AI took center stage on Day 1, with sessions showcasing its transformative potential across the oncology landscape. Key discussions highlighted AI’s ability to streamline cancer care, enhance clinical decision-making, and improve research efficiency. Notable findings included AI’s superior sensitivity in immunohistochemistry (IHC) scoring—particularly in identifying HER2-low and ultra-low breast cancers—and its application in biomarker assessment such as TROP2. Presenters also explored AI’s expanding role across the drug development continuum, from discovery and trial design to diagnostics and patient care. While the promise is clear, speakers emphasized the need for robust validation and regulatory oversight.
Circulating Tumor DNA: Shaping the Future of Precision Oncology
Circulating tumor DNA (ctDNA) also emerged as a key theme, with multiple sessions exploring its clinical utility. In colorectal cancer, ctDNA demonstrated strong prognostic value and potential for guiding intervention, particularly in minimal residual disease (MRD) detection as well as enabling clinical trial enrollment and shared decision-making. However, limitations in ctDNA assays sensitivity, lack of long-term survival data and guidelines remain barriers to routine adoption. However, several prospective studies on ctDNA guided management of CRC including DYNAMIC (II & III), Circulate, Circulate US and Circulate Spain could provide supportive evidence needed.
The Developmental Therapeutic session provided the preliminary results from the MONSTAR-SCREEN-3 study introduced a promising ultra-sensitive whole-genome sequencing (WGS) assay for MRD detection across tumor types, including traditionally low-shedding cancers. Furthermore, additional insights came from the I-SPY2 endocrine optimization pilot trial, which leveraged ctDNA for treatment stratification.
Developmental Therapeutics: Innovation in Early-Phase Trials
Rapid oral abstract sessions unveiled developments in targeted therapies. Early-phase trials of HER2- and HER3-directed antibody-drug conjugates (ADCs), including novel bispecific formats, showed encouraging activity in lung and other solid tumors. Although, the disappointing news of the failure of HERTHENA-Lung02 trial of HER3-directed antibody-drug conjugate (ADC) patritumab deruxtecan was also touched upon. Promising agents targeting neuroendocrine tumor markers such as delta-like ligand 3 (DLL3) and somatostatin receptor 2 (SSTR2) were also featured, signalling new avenues for precision treatment in this tumor type.
Advancing Care in Ultra-Rare Sarcomas
A dedicated session spotlighted the unique challenges in diagnosing and treating ultra-rare sarcomas, emphasizing the "data-free zone" that limits clinical knowledge and regulatory progress. Experts underscored the critical role of preclinical modeling in uncovering disease biology and accelerating the development of novel, targeted therapies.
Strategic Implications for Pharma
1. AI in Oncology: Accelerate Integration Across the Value Chain
Opportunity:
- AI is proving its value in diagnostics, biomarker discovery, and clinical trial optimization.
Action:
- Integrate AI tools into drug discovery, trial design, and patient stratification workflows. Collaborate with tech partners to co-develop validated, regulatory-compliant AI solutions.
- Strategic Value: Enhancing R&D efficiency and precision medicine capabilities can significantly reduce time-to-market and improve trial success rates.
2. ctDNA: Expand Liquid Biopsy Capabilities
Opportunity:
- ctDNA is gaining traction as a tool for MRD detection, prognosis, and treatment guidance, especially in colorectal and breast cancers.
Action:
- Invest in next-generation highly sensitive ctDNA assays
- Support clinical trials that validate ctDNA-guided treatment strategies.
- Strategic Value: Being at the forefront of liquid biopsy innovation can unlock new biomarker-driven therapies and enable more adaptive trial designs.
3. Developmental Therapeutics: Advance ADC and Bispecific Platforms
Opportunities:
- Paths forward for HER3-targeting ADCs (including bispecific and biparatopic ADCs) in advanced NSCLC after failure of EGFR TKI therapy.
- Early-phase data on DLL3 and SSTR2-targeted agents, show strong promise in neuroendocrine tumors.
Action:
- Accelerate pipeline development in ADCs (with TOP1i payloads) already particularly in solid tumors with high unmet need.
- Engage strategies to identify novel epitopes, bispecific or biparatopic antibodies being applied to HER2 and HER3 to improve therapeutic indices and overcome resistance.
- Explore target expansion and combination strategies for DLL3 and SSTR2 targeted agents.
- Strategic Value: These modalities represent the next wave of precision oncology, offering differentiated mechanisms and potential for breakthrough designations.
4. Ultra-Rare Sarcomas: Invest in Preclinical Innovation
Opportunity:
- There is a clear unmet need in ultra-rare sarcomas due to limited clinical data and regulatory hurdles.
Action:
- Pharma should prioritize investment in preclinical models and collaborative research to better understand disease biology and support regulatory pathways for orphan indications.
- Strategic Value: Early leadership in this space can position companies as pioneers in rare oncology, with potential for expedited approvals and market exclusivity.
Stay tuned for more daily highlights from our precision medicine experts at ASCO!
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