Metastatic colorectal cancer
Recent clinical, regulatory, research and industry developments relating to this disease.
Marketing authorisation: Fruzaqla (EMA)
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 5 clinical trials expected to report results, the earliest in Q1 2028.
- 4 industry developments reported.
- Q1 2028A Phase Ib/III Study of Suvemcitug Plus Trifluridine/Tipiracil Tablets (FTD/TPI) Versus Placebo Plus Trifluridine/Tipiracil Tablets in Participants With Refractory Metastatic Colorectal Cancer
- Q1 2028Bevacizumab-based Chemotherapy Tailored to the Pharmacokinetics of Bevacizumab in First-line Treatment of Unresectable Metastatic Colorectal Cancer: a Randomized, Multicenter, Double-blind Phase 3 Study
- Q3 2028Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)
- Q1 2030ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
- Q4 2030CAPRI-3 GOIM Study: Phase 3 Clinical Study to Evaluate the Use of Continuing Cetuximab Treatment Beyond First Line Progression in Molecular Selected Metastatic Colorectal Cancer Patients.
Clinical MilestonesViewHide
- 2026-10-23ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal CancerResults expected Q1 2030
- 2026-09-03Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)Results expected Q3 2028
- 2026-06-16Bevacizumab-based Chemotherapy Tailored to the Pharmacokinetics of Bevacizumab in First-line Treatment of Unresectable Metastatic Colorectal Cancer: a Randomized, Multicenter, Double-blind Phase 3 StudyResults expected Q1 2028
- 2026-02-05CAPRI-3 GOIM Study: Phase 3 Clinical Study to Evaluate the Use of Continuing Cetuximab Treatment Beyond First Line Progression in Molecular Selected Metastatic Colorectal Cancer Patients.Results expected Q4 2030
- 2026-01-22A Phase Ib/III Study of Suvemcitug Plus Trifluridine/Tipiracil Tablets (FTD/TPI) Versus Placebo Plus Trifluridine/Tipiracil Tablets in Participants With Refractory Metastatic Colorectal CancerResults expected Q1 2028
Industry & MarketViewHide
- 2026-09-01[Articles] Ifebemtinib plus garsorasib in previously treated metastatic colorectal cancer with KRASG12C mutation: a multicentre, randomised, phase 1b/2 trialTrial news · The Lancet Oncology
- 2026-08-27Long-Term Survival Outcomes of Modified-FOLFOXIRI Plus Cetuximab Versus Bevacizumab in RAS/BRAF Wild-Type Metastatic Colorectal Cancer: Final Analysis of the DEEPER TrialTrial news · Journal of Clinical Oncology
- 2026-07-29COMMIT: A Randomized Study of mFOLFOX6/Bevacizumab/Atezolizumab or Atezolizumab Alone as First-Line Treatment of Deficient DNA Mismatch Repair Metastatic Colorectal CancerResearch news · Journal of Clinical Oncology
- 2026-08-04Chemoimmunotherapy in Deficient DNA Mismatch Repair Metastatic Colorectal Cancer: What COMMIT Can and Cannot Tell UsIndustry · Journal of Clinical Oncology
- 2026-10-23ClinicalROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal CancerResults expected Q1 2030
- 2026-09-03ClinicalPhase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)Results expected Q3 2028
- 2026-09-01Industry[Articles] Ifebemtinib plus garsorasib in previously treated metastatic colorectal cancer with KRASG12C mutation: a multicentre, randomised, phase 1b/2 trialTrial news · The Lancet Oncology
- 2026-08-27IndustryLong-Term Survival Outcomes of Modified-FOLFOXIRI Plus Cetuximab Versus Bevacizumab in RAS/BRAF Wild-Type Metastatic Colorectal Cancer: Final Analysis of the DEEPER TrialTrial news · Journal of Clinical Oncology
- 2026-08-04IndustryChemoimmunotherapy in Deficient DNA Mismatch Repair Metastatic Colorectal Cancer: What COMMIT Can and Cannot Tell UsIndustry · Journal of Clinical Oncology
- 2026-07-29IndustryCOMMIT: A Randomized Study of mFOLFOX6/Bevacizumab/Atezolizumab or Atezolizumab Alone as First-Line Treatment of Deficient DNA Mismatch Repair Metastatic Colorectal CancerResearch news · Journal of Clinical Oncology
- 2026-06-16ClinicalBevacizumab-based Chemotherapy Tailored to the Pharmacokinetics of Bevacizumab in First-line Treatment of Unresectable Metastatic Colorectal Cancer: a Randomized, Multicenter, Double-blind Phase 3 StudyResults expected Q1 2028
- 2026-02-05ClinicalCAPRI-3 GOIM Study: Phase 3 Clinical Study to Evaluate the Use of Continuing Cetuximab Treatment Beyond First Line Progression in Molecular Selected Metastatic Colorectal Cancer Patients.Results expected Q4 2030
- 2026-01-22ClinicalA Phase Ib/III Study of Suvemcitug Plus Trifluridine/Tipiracil Tablets (FTD/TPI) Versus Placebo Plus Trifluridine/Tipiracil Tablets in Participants With Refractory Metastatic Colorectal CancerResults expected Q1 2028
- 2025-12-01ClinicalA Phase 3, Randomized, Open-Label, Multicenter Trial of Sym004 Versus Trifluridine/Tipiracil (TAS-102) in Patients With Chemotherapy-Refractory or Relapsed Metastatic Colorectal Carcinoma and Acquired Resistance to Anti-EGFR Monoclonal Antibody TherapyWithdrawn
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Original application approval — Fruzaqla as monotherapy is indicated for the treatment of adult patients with metastatic… (2024)
Original application approval — MelanomaEncorafenib in combination with binimetinib is indicated for the treatment of adu… (2018)
Original application approval — Colorectal cancer Lonsurf is indicated in combination with bevacizumab for the treatment… (2016)
Original application approval — Melanoma Opdivo as monotherapy or in combination with ipilimumab is indicated for the tr… (2015)
Original application approval — Melanoma Keytruda as monotherapy is indicated for the treatment of adults and adolescents… (2015)
Original application approval — Gastric cancer Cyramza in combination with paclitaxel is indicated for the treatment of a… (2014)
Original application approval — Treatment of metastatic colorectal cancer (MCRC). (2013)
Original application approval — Stivarga is indicated as monotherapy for the treatment of adult patients with: metastati… (2013)
Clinical trials
The current development programme across all trial phases.
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Associated genes
Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.
Disease biology
Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Related entities are derived from literature co-mention (studied together) — associative, not causal.