Progress in Gastrointestinal Oncology: 5 Key Insights from ASCO GI

Despite accounting for 1 in 4 cancer deaths, gastrointestinal (GI) cancers receive significantly less attention than lung and breast cancer. While other oncology fields have seen breakthrough innovations, pancreatic, colorectal, and gastric cancers remain stubbornly resistant to treatment.¹

The ASCO GI 2025 Symposium brought these challenges into sharp focus. Leading researchers presented the many challenges and opportunities of this field, and we outline them here. This article covers:

• The current challenges in GI research and development
• How Precision’s expertise positions Sponsor partners for success
• 5 key learnings from ASCO GI that could impact future GI therapies

Why GI cancers are still decades behind—and how we change that now

The ASCO GI 2025 conference highlighted several barriers to progress:

• Pancreatic cancer stagnation: Little progress has been made in first-line metastatic pancreatic cancer treatments over the last decade, with overall survival remaining poor.¹
• Cold tumors and immunotherapy challenges: Unlike lung and breast cancers, many GI tumors lack immune activation, making immunotherapy far less effective.²
• Limited success in cell therapy: CAR-T therapies, which have transformed blood cancers, have struggled to make an impact in solid tumors like gastric and colorectal cancers.³
• The need for precision medicine: New biomarkers and targeted therapies are emerging but require more adaptive clinical trial designs and specialized expertise to bring them to patients faster.⁴

5 Key Learning from ASCO GI 2025 that could shape the future of GI oncology

1. Pan-RAS Inhibitors Show Deep Molecular Responses in PDAC

For the first time, a targeted therapy is showing meaningful molecular responses in pancreatic ductal adenocarcinoma (PDAC), one of the most treatment-resistant cancers. This breakthrough could open the door to precision treatments that directly inhibit RAS mutations, a long-standing challenge in pancreatic cancer therapy.⁵

2. ctDNA Analysis Gains Traction in Treatment Monitoring

Circulating tumor DNA (ctDNA) is emerging as a powerful, non-invasive tool for monitoring treatment response in pancreatic cancer. Instead of waiting months for scans, clinicians could track tumor evolution in real-time (minimal residual disease [MRD] concept), leading to faster, more adaptive treatment decisions.⁶

3. Everolimus Plus Lanreotide Extends Progression-Free Survival

A combination approach using Everolimus and Lanreotide has shown extended progression-free survival (PFS) in gastroenteropancreatic neuroendocrine tumors. This is an encouraging step forward in hormone-driven GI cancers, where treatment options remain limited.⁶

4. Bispecific and Antibody-Drug Conjugates (ADCs) Expand Options for GI Cancers

The development of HER2-targeted therapies like Zanidatamab offers new treatment avenues for biliary tract cancers, an area with historically poor therapeutic options. As antibody-drug conjugates (ADCs) gain momentum, we’re seeing a shift toward more precise, less toxic treatments in GI oncology.⁷

5. Cancer Vaccines for GI Oncology: A Long-Awaited Breakthrough?

mKRAS-targeted vaccines are now showing promise in patients with MSS colorectal cancer, a group that has historically been resistant to immunotherapy. If successful, these personalized and off-the-shelf vaccines could revolutionize the way we treat previously untreatable GI cancers.⁴

Precision for Medicine’s Impact in Gastrointestinal Oncology Trials

Precision advances treatments through innovative trial designs and operational excellence. Our track record includes 77 GI Oncology Trials:

• 30 First-in-Human Studies
• >93% of studies in early-phase development (37.7% Phase 1; 42.86% Phase 1/2; 13% Phase 2)
• Precision studies enroll 20% more subjects than the industry average (141.6 vs. 113.7).
• Trials are conducted across twice as many sites as the industry standard (26.4 vs. 13.2)

This strong foundation in GI oncology allows us to accelerate development, improve trial efficiency, and bring novel therapies to patients faster.

• Biomarker-driven patient selection to improve trial efficiency
• Real-world evidence generation to support regulatory and commercial strategies
• Decentralized and hybrid trial designs that enhance patient access and retention.

Precision for Medicine addresses key GI research challenges with deep early-phase oncology and rare disease expertise

Translating Rare Disease Expertise into GI Oncology

Precision’s experience managing small patient populations and biomarker-driven studies in rare diseases applies directly to understudied GI cancers, such as neuroendocrine tumors, cholangiocarcinoma, hepatocellular carcinoma, pancreatic, and esophageal cancers.

Supporting Innovation in Cell and Gene Therapy

While CLDN 18.2-targeted CAR-T therapy has shown promise, success requires better patient selection, toxicity management, and trial execution—areas where Precision excels.

Advancing Theranostics and Radiopharmaceuticals

Emerging targeted radionuclide therapies are providing new opportunities in GI oncology, and Precision is helping optimize these trials.

Optimizing Immuno-Oncology Strategies

From bispecific antibodies to novel checkpoint inhibitors, Precision is helping biotech and pharma test and refine immunotherapy combinations to tackle immune-cold tumors.

Accelerating innovation in gastrointestinal oncology clinical trials

GI cancers have waited long enough. Pancreatic and colorectal patients still face the same grim statistics they did a decade ago, but the science is catching up. 2025’s breakthroughs signal a turning point, but the key to impact isn’t just discovery—it’s speed.

Bringing these new treatments to patients faster requires a partner who understands both:

• The science of GI oncology—from biomarkers to targeted therapies.
• The strategy of accelerating trials—with adaptive study designs and regulatory expertise.

Proceed with Precision to turn your research into a clinical reality.

References

1. Skorupan N. First-Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma: Did 2025 Offer New Insights? ASCO GI 2025.
2. El-Khoueiry A. Novel Immuno-Oncology Approaches for Lower GI Cancers. ASCO GI 2025.
3. Shitara K. Emerging Therapies in GI Cancers: CAR-T Therapy. ASCO GI 2025.
4. Haldar S. Cancer Vaccines: Progress on the Promise? ASCO GI 2025.
5. Lawrence L. Pan-RAS Inhibitor Shows Early, Deep Molecular Responses in PDAC. ASCO GI 2025.
6. Norton A. ctDNA Analysis Shows Promise for Treatment Monitoring in Advanced Pancreatic Cancer. ASCO GI 2025.
7. Weekes CD. Emerging Therapies in Gastrointestinal Cancers: Bispecifics and Antibody-Drug Conjugates. ASCO GI 2025.tbl