Colosoto

Colosoto is the first European study in which GONO is participating as part of the international ENGIC (European Network In GastroIntestinal Cancer) collaboration.
The study is sponsored by the French group FFDC and will be conducted in France, Italy, Germany and Spain.

5-Fluorouracil or capecitabine plus bevacizumab are recommended by major international guidelines as first-line treatment for metastatic colorectal cancer (mCRC) patients unfit for irinotecan or oxaliplatin-based chemotherapy. 5-Fluoruracil plus an anti-EGFR is a valid option in unfit patients with left-sided RAS and BRAF wt mCRC.
Sotorasib, a KRAS G12C protein inhibitor, in combination with the anti-EGFR panitumumab, has shown a significant efficacy with increased overall response rate (ORR) and progression-free survival (PFS), as compared to regorafenib or trifluridine-tipiracil in pre-treated mCRC patients harbouring KRAS G12C mutation. Moreover, Codebreak 101 trial combining sotorasib plus panitumumab and FOLFIRI in the first-line setting demonstrated a manageable safety profile and promising ORR, with no meaningful difference in treatment-emergent adverse events, regardless of the patient age.
Driving from these considerations, we designed the present phase II study investigating the combination of sotorasib and panitumumab with 5-Fluoruracil in the first-line setting of mCRC patients with KRAS G12C mutation unfit for a combinatory chemotherapy regimen due to age or clinical conditions.

Main criteria:

– mCRC patients unfit for doublet/triplet regimen with locally assessed KRAS G12C mutation not previously treated with chemotherapy for metastatic disease meeting one of these criteria:
– WHO Performance status = 2
– WHO Performance status = 1 with an age between 70 and 75 years
– 75 years or more

The aim is to determine the efficacy of 5-Fluoruracil plus sotorasib and panitumumab in terms of rate of patients alive without progression 8 months after the inclusion.