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CytomX's Varsetatug Masetecan (EpCAM PROBODY® ADC) Continues to Demonstrate Positive Data Supporting Potential as a New Treatment Option in Late-Line Colorectal Cancer

CTMX
  • Confirmed response rates in Phase 1 expansion cohorts were 32% at 10 mg/kg Q3W & 20% at 8.6 mg/kg Q3W for varsetatug masetecan (Varseta-M) in late-line metastatic colorectal cancer.
  • Estimated median progression-free survival was 7.1 months at 10 mg/kg & 6.8 months at 8.6 mg/kg based on January 16, 2026 data cutoff.
  • Grade 3 diarrhea occurred in 10% of the 20 patients enrolled in ongoing dose optimization cohorts using updated prophylaxis regimens.
  • CytomX Therapeutics plans FDA interactions in mid-2026 to align on a potential registrational trial design for Varseta-M in late-line colorectal cancer.
  • A Phase 1 study evaluating Varseta-M combination with bevacizumab has been initiated, with a Phase 1b/2 chemotherapy combination study scheduled to begin by the end of 2026.
  • The CTMX-2051-101 study enrolled 93 patients total, with 56 efficacy-evaluable patients across expansion doses of 7.2 mg/kg, 8.6 mg/kg, & 10 mg/kg.
  • Most enrolled patients had received a median of 3 prior therapies, with 96% previously treated with irinotecan, 76% having liver metastases, & 71% having KRAS mutations.
  • Safety data showed no interstitial lung disease, febrile neutropenia, or pancreatitis, with Grade 3 diarrhea being the most common manageable adverse event.
  • One treatment-related Grade 5 acute kidney injury was reported in a patient at the 7.2 mg/kg dose with complex medical history, with no other Grade 5 events as of the cutoff.
  • The company aims to advance Varseta-M to earlier lines of treatment & additional EpCAM-expressing cancers, with Phase 1 expansion in new indications planned for the second half of 2026.
  • A conference call to discuss these findings is scheduled for Monday, March 16, 2026, at 8:00 a.m. ET.