CRC Research Update

  • REGULATORY

    FDA converts pembrolizumab approval for TMB-high tumors, raises threshold to ≥13 mutations/megabase

    The FDA granted traditional approval for pembrolizumab in unresectable or metastatic TMB-high solid tumors, updating the definition from ≥10 to ≥13 mutations/megabase after efficacy was not confirmed in the 10 to <13 range. (FDA)

  • SCREENING

    Mailed FIT outreach raises screening rates to 39% in underserved populations after three years

    A randomized trial across 16 community health clinics found that annual mailed fecal immunochemical test kits with educational materials and phone reminders increased screening uptake to 39.4% at year three, compared to 36.5% in usual care; a statistically significant difference of 10.8 percentage points was observed at year two (37.8% vs 27.0%). Due to a resource constraint-related protocol modification, mailed FIT outreach began earlier in year 3, such that some individuals who completed screening in year 2 were not yet due for repeat FIT. (JAMA Network Open)

  • TREATMENT

    Phase II trial tests anti-EGFR rechallenge in ctDNA-selected metastatic CRC

    The ROMANCE trial is randomizing 150 patients with circulating tumor DNA-negative hyperselected metastatic colorectal cancer to irinotecan plus cetuximab rechallenge versus trifluridine/tipiracil plus bevacizumab as third-line therapy, aiming to improve objective response rates. (Clinical Colorectal Cancer)

  • TREATMENT

    Metastasis resection after biomarker-guided chemotherapy extends survival to 61 months

    In the IVOPAK II study, patients with initially nonresectable metastatic colorectal cancer who underwent secondary metastasis resection after biomarker-stratified first-line treatment had a median overall survival of 61 months versus 22 months for chemotherapy alone. (Oncology)

🧬 Biomarker Spotlight

Research by genetic subtype. KRAS, BRAF, MSI-H, HER2, and more

This week's research spans regulatory updates, screening strategies, and biomarker-guided treatment approaches in metastatic disease.