Attending the ASCO Annual Meeting is always a timely pulse check on where oncology is headed and ASCO 2025 made it clear that innovation is accelerating across every facet of cancer research. From next-generation biologics to smarter diagnostics and evolving trial strategies, sponsors are navigating a rapidly changing landscape that demands both agility and global perspective.
At Novotech, we used ASCO as a platform not only to analyze the scientific advances but also to engage directly with biotech and pharma sponsors. Through these conversations, we gained important insight into the real-world challenges and priorities shaping oncology trial strategy in 2025.
Insights from Sponsor Conversations: Pressure, Prioritization, and New Geographies
Several consistent themes emerged in our meetings with sponsors:
Uncertainty in the U.S. Research Environment
Sponsors are expressing concern about the evolving regulatory and funding landscape in the U.S., prompting many to diversify their early-phase strategy geographically. Australia continues to stand out due to its streamlined regulatory process, cost efficiencies, and access to highly experienced investigators and research centers.
Heightened Cost Sensitivity
There is increasing demand for trial designs that are cost-effective without compromising scientific rigor. Many sponsors are actively exploring Asia-Pacific (APAC) and select Central and Eastern European countries as strategic locations for first-in-human (FIH) and early-phase trials, citing both operational efficiencies and regulatory predictability.
Translating ASCO Highlights into Operational Advantage
The scientific sessions at ASCO 2025 brought the future of oncology into focus. Here are some of the key highlights and how Novotech is helping sponsors bring these insights to life:
Day 1: Driving Precision with Smarter Tools
AI in Oncology Diagnostics
AI is reshaping how biomarkers are interpreted and how sites are selected. Novotech uses AI to accelerate patient enrollment and scale complex trials particularly in cell and gene therapies ensuring sponsors gain a time and cost advantage.
ctDNA and MRD Monitoring
As ctDNA becomes central to tracking minimal residual disease, particularly in colorectal cancer, our infrastructure supports real-time molecular tracking and adaptive trial models that align with this evolving standard of care.
Next-Generation ADCs and Targeted Therapies
With promising new agents targeting HER2/HER3, DLL3, and SSTR2, our global oncology teams are supporting trials across solid and hematologic malignancies, especially where early-phase expertise and rapid site activation are critical.
Rare and Ultra-Rare Sarcomas
Recruiting for ultra-rare sarcomas remains a challenge. With operational hubs across Asia-Pacific, North America, and Europe, Novotech enables faster recruitment in hard-to-reach populations and supports innovative, small-cohort designs.
Day 2: Infrastructure for Innovation
VERITAC-2 Trial – Breast Cancer
Vepdegestrant showed promising results in ER+/HER2- patients. Our capabilities in genomic profiling and hormone-receptor trial experience in Asia-Pacific allow us to support endocrine-focused studies with precision.
PANOVA-3 – Pancreatic Cancer
Device-drug combination trials, like TTFields, demand operational flexibility. Novotech’s regulatory navigation experience across regions supports the unique needs of these studies in pancreatic and other GI cancers.
C-POST – High-Risk CSCC
Cemiplimab demonstrated a clear survival benefit. Our strengths in immuno-oncology trials, long-term follow-up, and real-world data infrastructure make us a valuable CRO partner for sponsors pursuing adjuvant or post-surgical therapies.
Day 3: Long-Term Value and Stratified Approaches
CheckMate-214 – Renal Cell Carcinoma
With over eight years of follow-up, this trial highlights the need for endurance in operations and data continuity. Novotech is built for extended endpoint collection and long-term survival tracking across geographies.
HERTHENA-Lung02 – EGFR-Mutated NSCLC
This ADC demonstrated intracranial efficacy in EGFR-mutated lung cancer, especially relevant to Asia-Pacific. Novotech offers both the CNS expertise and patient access necessary for such targeted studies.
KRYSTAL-7 – KRASG12C-Mutated NSCLC
Adagrasib plus pembrolizumab is showing promise across PD-L1 expression levels. With our biomarker stratification capabilities and adaptive design execution, Novotech enables efficient hypothesis testing and escalation modeling.
What This Means for Sponsors
Precision is the Baseline
Biomarker-driven designs, real-time analytics, and adaptive trial methodologies are no longer optional. Sponsors need CROs with the tools and teams to deliver this from Day 1.
Cost Efficiency Is Driving Strategy
Sponsors are under pressure to reduce costs without sacrificing quality. Our proven track record across cost-effective regions like Australia, APAC, and Central Europe offers a practical advantage.
The Rise of Complex Modalities
ADCs, device-drug combos, and next-gen biologics are expanding. Novotech’s global capabilities are designed to support these protocols from regulatory strategy to final data lock.
Rare Populations Are Central, Not Peripheral
Patient access for rare and ultra-rare indications continues to define trial timelines. Our reach into underserved populations accelerates recruitment and improves study feasibility.
Durability and Real-World Data Are Key
Long-term outcomes and RWE are now essential for approvals and post-market access. Novotech’s infrastructure is aligned to deliver evidence that sustains product value over time.
Closing Thought
ASCO 2025 reinforced what we hear from sponsors every day: oncology is moving fast, and the pressure to deliver smarter, more cost-effective trials has never been greater. For sponsors, choosing the right CRO isn’t just about execution it’s about partnership. At Novotech, we’re committed to translating global insights into local success, and to supporting our partners at every step of the journey from science to solution.
If you're navigating complex oncology development in 2025, we’re here to help you move forward strategically, efficiently, and globally.