The randomized Phase 2 CAVE-2 GOIM trial found that adding the PD-L1 inhibitor avelumab to cetuximab rechallenge did not significantly improve progression-free survival (PFS) or overall survival (OS) compared to cetuximab monotherapy in patients with RAS/BRAF wild-type (WT) metastatic colorectal cancer (mCRC).
The study confirms the critical role of liquid biopsy comprehensive genomic profiling (CGP) using FoundationOne Liquid CDx to identify patients eligible for anti-EGFR rechallenge.
A pre-planned ‘negative hyper-selection’ analysis revealed that patients without mutations in a specific 10-gene panel (including KRAS, NRAS, BRAF, EGFR ECD, PIK3CA, and others) achieved significantly better clinical outcomes.
Negative hyper-selection resulted in a median OS of 15.0 months compared to 11.1 months for those with detectable resistance mutations, supporting the integration of liquid biopsy into the mCRC continuum of care.
Background: The Evolution of Anti-EGFR Rechallenge
