Dr García-Carbonero on Outcomes With Fruquintinib in mCRC Subgroups

“We demonstrated improved PFS and DCR [with fruquintinib vs placebo] in all the [metastatic] subgroups. This is good news; [patients with] certain sites of metastasis that can have a poor prognosis, but they all can benefit from fruquintinib therapy.”

Rocío García-Carbonero, MD, a medical oncologist and leader of both the Gastrointestinal Tumor and Neuroendocrine Units at Hospital Universitario 12 de Octubre, a well as an associate professor at Universidad Complutense of Madrid, discussed findings from a subgroup analysis of the phase 3 FRESCO-2 trial (NCT04322539), which evaluated fruquintinib (Fruzaqla) for the treatment of patients with metastatic colorectal cancer (mCRC).

During 2025 ESMO Gastrointestinal Cancers Congress, García-Carbonero presented data from a subgroup analysis of FRESCO-2 that examined fruquintinib vs placebo, both in combination with best supportive care, in patients with mCRC with disease metastasis to various sites, including the liver-only, lung-only, bone with/without other metastases, and peritoneum with/without other metastases, García-Carbonero began. Patients who received fruquintinib experienced an improvement in overall survival (OS) across most key subgroups, she explained.

Patients with liver-only metastases who in the investigational (n = 19) and control (n = 10) arms experienced a median OS of 8.5 months vs 3.1 months, respectively (HR, 0.256; 95% CI, 0.079-0.824; P = .0760). The median OS in the investigational arm in patients with lung-only metastases (n = 25) was 14.1 months compared with not estimable in the control arm (n = 16; HR, 0.998; 95% CI, 0.208-4.792; P = .9561). Patients in the bone metastases subgroup experienced a median OS of 7.6 months with fruquintinib (n = 51) vs 3.4 months with placebo (n = 27; HR, 0.399; 95% CI, 0.215-0.741; P = .0065). In the peritoneal metastases subgroup, the median OS values were 5.4 months and 4.2 months in the investigational (n = 67) and control (n = 38) arms, respectively (HR, 0.669; 95% CI, 0.395-1.134; P = .2453).

The OS data were more prognostic than predictive, García-Carbonero noted. In the lung-only metastasis cohort, OS data were immature due to a lack of events, although a trend n favor of fruquintinib was reported, she added. The median progression-free survival (PFS) and disease control rates (DCR) were also improved with fruquintinib vs placebo across subgroups, she concluded.