“We see that fruquintinib improved overall survival in all [metastatic] subgroups. Survival [outcomes] with fruquintinib are much better in [patients with] lung [metastases] than in [those with] liver or bone [metastases], and the worst [outcomes] were in [patients with] peritoneal disease. However, these are more prognostic rather than predictive factors, because within each subgroup, fruquintinib improves survival vs placebo.”
Rocío García-Carbonero, MD, of Hospital Universitario 12 de Octubre, discussed updated findings from a prespecified subgroup analysis of the phase 3 FRESCO-2 trial (NCT04322539), which evaluated fruquintinib (Fruzaqla) vs placebo in patients with refractory metastatic colorectal cancer (mCRC). The subgroup analysis focused on outcomes by site of baseline metastases.
Data presented at the 2025 ESMO Gastrointestinal Cancers Congress included outcomes stratified by liver, lung, bone, and peritoneal metastatic involvement. In this analysis, fruquintinib demonstrated improved overall survival (OS), progression-free survival (PFS), and disease control rate (DCR) across all metastatic subgroups when compared with placebo. The OS benefit was observed in patients with liver-only metastases (HR, 0.256; 95% CI, 0.079-0.824; P = .0760); those with bone metastases with or without other metastatic sites (HR, 0.399; 95% CI, 0.215-0.741; P = .0065); and those with peritoneal metastases with or without other metastatic sites (HR, 0.669; 95% CI, 0.395-1.134; P = .2453). An OS benefit was not observed within the lung-only metastases subgroup (HR, 0.998; 95% CI, 0.208-4.792; P = .9561); however, García-Carbonero explained that data for this subgroup were immature. The median OS in the lung-only subgroup was 14.1 months for fruquintinib vs not evaluable for placebo.
Importantly, the findings were derived from a post hoc analysis with small patient numbers, precluding definitive conclusions. Nonetheless, García-Carbonero emphasized that the data support the broad applicability of fruquintinib in the refractory mCRC setting, even in patients with metastases associated with poorer prognosis.