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ASCO 2025 Gastrointestinal Cancer Preview: Key Studies to Watch According to DelveInsight
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Top Gastrointestinal Cancers Abstracts | ASCO 2025
The ASCO 2025 conference is set to highlight pivotal breakthroughs in gastrointestinal cancers, particularly in metastatic colorectal cancer (mCRC), pancreatic cancer, gastric/gastroesophageal junction adenocarcinoma, and others, highlighting advances in biomarker-driven therapies, novel immunotherapy combinations, and several other treatment regimens across early and advanced disease settings. Leading pharmaceutical and biotech companies—including Amgen, Daiichi Sankyo, AstraZeneca, Pfizer, Bristol Myers Squibb, Merck, Incyte, Eli Lilly, Novocure and others—will present late-phase trial data and novel therapeutic strategies.
Key presentations will focus on targeted therapies (such as KRAS and BRAF inhibitors), immuno-oncology combinations, optimized chemotherapy regimens, and others. Noteworthy sessions include results from the BREAKWATER, DESTINY-Gastric04, MATTERHORN, and ATOMIC trials, all expected to drive forward clinical discussions and influence treatment paradigms in GI oncology.
Colorectal cancer originates in the colon or rectum and progresses from Stage 0, which is localized and highly treatable, to Stage 4, where it metastasizes to distant organs such as the liver, lungs, or peritoneum. mCRC represents this advanced stage, with the United States reporting nearly 152,500 incident cases in 2024—a number projected to rise by 2034 at a steady CAGR.
At ASCO 2024, colorectal cancer is one of the major focuses, with significant updates in first-line and biomarker-driven therapies. Key highlights include the BREAKWATER trial in BRAF V600E-mutant mCRC, promising KRAS G12C inhibitors like olomorasib and MK-1084, and notable immunotherapy data from the CheckMate 8HW and ATOMIC trials in MSI-H/dMMR and dMMR subtypes.
The top abstracts within gastrointestinal cancer from DelveInsight listed below hold promise for significant advancements, aiming to positively impact the lives of patients affected by gastrointestinal cancers.
Gastrointestinal Cancer Key Abstracts
|
Company |
Drug |
Trial ID/ Acronym |
Phase |
Patient Segment |
Abstract ID |
Session Type |
Abstract Title |
|
|
BRAFTOVI (encorafenib) + cetuximab with or without chemotherapy |
NCT04607421 (BREAKWATER) |
III |
mCRC |
LBA3500 |
Oral |
First-line encorafenib + cetuximab + mFOLFOX6 in BRAF V600E-mutant metastatic colorectal cancer (BREAKWATER): Progression-free survival and updated overall survival analyses |
|
|
ENHERTU (trastuzumab deruxtecan) |
NCT04704934 |
III |
GC/GEJC Adenocarcinoma |
LBA4002 |
Oral |
Trastuzumab deruxtecan (T-DXd) vs ramucirumab (RAM) + paclitaxel (PTX) in second-line treatment of patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) unresectable/metastatic gastric cancer or gastroesophageal junction adenocarcinoma (GEJA): Primary analysis of the randomized, phase III DESTINY-Gastric04 study |
|
|
Tumor treating fields (TTFields) + Gemcitabine + nab-paclitaxel |
NCT03377491 |
III |
Locally advanced PDAC |
LBA4005 |
Oral |
PANOVA-3: Phase III study of tumor treating fields (TTFields) with gemcitabine and nab-paclitaxel for locally advanced pancreatic ductal adenocarcinoma (LA-PAC) |
|
|
JMT101 and Irinotecan Combined With SG001 |
NCT06089330 |
II |
mCRC |
LBA3516 |
Rapid Oral |
JMT101 in combination with irinotecan and SG001 versus regorafenib in patients with metastatic colorectal adenocarcinoma (mCRC): Results of a randomized, controlled, open-label, phase II study |
|
|
TECENTRIQ (atezolizumab) |
NCT02912559 (ATOMIC) |
III |
Stage III deficient dMMR colon cancer |
LBA1 |
Plenary |
Randomized trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III deficient DNA mismatch repair (dMMR) colon cancer (Alliance A021502; ATOMIC) |
|
|
IMFINZI (durvalumab) and FLOT chemotherapy |
NCT04592913 (MATTERHORN) |
III |
Resectable GC/GEJC |
LBA5 |
Plenary |
Event-free survival (EFS) in MATTERHORN: A randomized, phase III study of durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel chemotherapy (FLOT) in resectable gastric/gastroesophageal junction cancer (GC/GEJC) |
|
|
OPDIVO |
NCT02743494 (CheckMate 577) |
III |
EC/GEJC |
4000 |
Oral |
Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT): First results of overall survival (OS) from CheckMate 577 |
|
|
LUMAKRAS (sotorasib) + panitumumab + FOLFIRI |
NCT05198934 |
III |
Previously treated KRAS G12C-mutated mCRC |
3506 |
Oral |
Long-term safety and efficacy of sotorasib plus panitumumab and FOLFIRI for previously treated KRAS G12C-mutated metastatic colorectal cancer (mCRC): CodeBreaK 101 (phase Ib) |
|
|
Elraglusib + gemcitabine/nab-paclitaxel |
NCT03678883 |
II |
Previously untreated metastatic PDAC |
4006 |
Oral |
Preliminary results from the randomized phase II study (1801 part IIIB) of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) versus GnP alone in patients (pts) with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC) |
|
|
Olomorasib (LY3537982) |
NCT04956640 |
I/II |
KRAS G12C-mutant advanced CRC |
3507 |
Oral |
Efficacy and safety of olomorasib, a second-generation KRAS G12C inhibitor, plus cetuximab in KRAS G12C-mutant advanced colorectal cancer |
|
|
Vilastobart (XTX101) + TECENTRIQ |
NCT04896697 |
II |
MSS CRC |
3553 |
Poster |
Vilastobart (XTX101), a tumor-activated, Fc-enhanced anti–CTLA-4 monoclonal antibody, in combination with atezolizumab in patients with MSS CRC |
|
|
DSP107 |
NCT04440735 |
I/II |
Metastatic MSS CRC |
3517 |
Rapid Oral |
Phase II dose expansion study of DSP107, a first-in-class bi-specific 4-1BB T-cell engager, with and without atezolizumab in metastatic MSS colorectal cancer patients |
|
|
MK-1084 |
NCT05067283 |
I |
KRAS G12C–mutated advanced CRC |
3508 |
Oral |
The KRAS G12C inhibitor MK-1084 for KRAS G12C–mutated advanced colorectal cancer (CRC): Results from KANDLELIT-001 |
|
PDAC: Pancreas ductal adenocarcinoma; CRC: Colorectal cancer; NET: Neuroendocrine tumors; SCAC: Squamous cell carcinoma of the anal canal; GC/GEJC: Gastric/gastroesophageal junction cancer, MSS: microsatellite stable | |||||||
Executive Summary
The ASCO 2025 conference is set to highlight pivotal breakthroughs in gastrointestinal cancers, particularly in metastatic colorectal cancer (mCRC), pancreatic cancer, gastric/gastroesophageal junction adenocarcinoma, and others, highlighting advances in biomarker-driven therapies, novel immunotherapy combinations, and several other treatment regimens across early and advanced disease settings.