Also known as: metastatic CRC
Lyell Immunopharma initiated the Phase 3 PiNACLE–H2H trial of ronde-cel in large B-cell lymphoma and reported that GI prophylaxis reduced severe diarrhea rates from 55% to 10% in the Phase 1 LYL273 trial.
The FDA has approved Pfizer's BRAFTOVI for BRAF V600E metastatic colorectal cancer and VEPPANU for ESR1 mutated breast cancer. The oncolytic virus cancer therapy pipeline expands with over 120 companies developing 125+ drugs. Positive late-stage data for other Pfizer oncology programs was also reported.
Pfizer reported positive topline PFS results for encorafenib plus cetuximab and FOLFIRI in BRAF V600E-mutant mCRC from BREAKWATER cohort 3. The regimen showed significant PFS improvement and clinically meaningful OS benefit, with no new safety signals.
Phase 3 BREAKWATER found encorafenib plus cetuximab plus FOLFIRI improved PFS and response in first-line BRAF V600E-mutant metastatic colorectal cancer. OS data remain immature.
Pfizer reported new clinical and regulatory milestones across oncology, obesity and hemophilia, including BREAKWATER Phase 3 data and Priority Review for HYMPAVZI. The company also cited MagnetisMM-5 results and FDA priority review for PADCEV.
Adagene and Incyte will collaborate on a Phase 1 study combining muzastotug with INCA33890 for MSS colorectal cancer patients, beginning in 2026. The collaboration marks the second instance where Adagene's SAFEbody technology is paired with a PD-1-based bispecific. Muzastotug has shown encouraging response rates in combination with pembrolizumab in previous trials.
Oncolytics Biotech received FDA Fast Track Designation for pelareorep in KRAS-mutant colorectal cancer based on data showing 33% response rate and 27-month median survival. The company is launching a Phase 2 study and recently completed reincorporation from Canada to Nevada. This marks the second Fast Track Designation for pelareorep in gastrointestinal cancers.
Iterion Therapeutics has dosed the first patient in a phase 1/2 trial of its Wnt/β-catenin inhibitor tegavivint for metastatic colorectal cancer. The expansion builds on promising monotherapy activity observed in advanced hepatocellular carcinoma, targeting a pathway activated in over 90% of colorectal cancer patients.
Colorectal cancer diagnoses in people under 50 now account for nearly half of all new cases, prompting specialized treatment programs that use precision medicine and liquid biopsy technology to customize care based on individual tumor genetics.
Colorectal cancer rates are rising 3% annually in adults under 50, prompting expanded screening efforts and new treatment approaches. Recent research shows promise in combination immunotherapy and vaccine strategies for advanced disease.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07754513 |
Circulating Tumor Extracellular Vesicles for Non-Invasive Monitoring of Metastatic Colorectal Cancer |
NOT_YET_RECRUITING | |
| NCT07720115 |
Phase 2 Trial Of S-531011 With RadScopal In Previously Treated Metastatic Colorectal Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07718490 |
Immunotheray Combined With Simvastatin and Target Therapy and Chemotharepy for Advanced Colorectal Cancer |
RECRUITING | PHASE2 |
| NCT07662031 |
Tovecimig Plus FOLFIRI in Second Line Metastatic Colorectal Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07623174 |
A Study of Fruquintinib in Adults With Metastatic Colorectal Cancer in Poland |
NOT_YET_RECRUITING | |
| NCT07617610 |
Primary and Acquired Resistance to Targeted Treatment in BRAF V600E-mutated Metastatic Colorectal Cancer |
RECRUITING | |
| NCT07559760 |
New Second-Line Combo Therapy for MSS Metastatic Colorectal Cancer |
RECRUITING | PHASE2 |
| NCT07549412 |
A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03) |
RECRUITING | PHASE3 |
| NCT07543744 |
A Comparative Study of Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix® in Patients With Metastatic Colorectal Cancer With Wild-type RAS as First-line Therapy in Combination With FOLFIRI |
RECRUITING | PHASE1 |
| NCT07503756 |
JS212 Combination Therapies in Metastatic Colorectal Cancer |
RECRUITING | PHASE2 |
