Fruquintinib Shows Promise for Metastatic Colorectal Cancer Patients

At the 2025 ESMO Gastrointestinal Cancers Congress, Dr. Rocío García-Carbonero, MD, of Hospital Universitario 12 de Octubre, presented compelling findings from a prespecified subgroup analysis of the phase 3 FRESCO-2 trial, which evaluated the efficacy of fruquintinib (Fruzaqla) compared to placebo in patients with refractory metastatic colorectal cancer (mCRC). This analysis specifically focused on survival outcomes stratified by the site of baseline metastases, which included liver, lung, bone, and peritoneal involvement.

In her presentation, Dr. García-Carbonero emphasized that fruquintinib significantly improved overall survival (OS), progression-free survival (PFS), and disease control rate (DCR) across all metastatic subgroups when compared to placebo. For patients with liver-only metastases, the hazard ratio (HR) for OS was reported at 0.256 (95% confidence interval [CI], 0.079-0.824; P = .0760). The benefit was similarly observed in those with bone metastases (HR, 0.399; 95% CI, 0.215-0.741; P = .0065) and peritoneal metastases (HR, 0.669; 95% CI, 0.395-1.134; P = .2453). However, the subgroup analysis for lung-only metastases yielded an HR of 0.998 (95% CI, 0.208-4.792; P = .9561), indicating that the data for this subgroup were immature, and thus, not conclusively interpretable.

Dr. García-Carbonero remarked, "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, while the worst outcomes were observed in patients with peritoneal disease. However, these findings are more prognostic than predictive, as fruquintinib improves survival across all subgroups when compared to placebo."

The FRESCO-2 trial, registered under NCT04322539, represents a significant advancement in understanding the treatment landscape for mCRC, particularly for patients with refractory disease. While the results indicate a broad applicability of fruquintinib, particularly for those with poorer prognostic factors, Dr. García-Carbonero cautioned that the findings stem from a post hoc analysis with limited patient numbers, which may affect the reliability of the conclusions drawn.

The implications of this study are substantial as they showcase the potential for fruquintinib to offer new hope to patients with refractory mCRC, particularly those with liver and bone metastases. The necessity for further studies to validate these findings remains critical, and researchers are encouraged to explore the drug's efficacy across larger and more diverse populations.

Future research may also focus on identifying biomarkers that could predict which patients are most likely to benefit from fruquintinib, thereby enhancing personalized treatment strategies in metastatic colorectal cancer. As the oncology community continues to seek effective therapies for mCRC, the findings presented by Dr. García-Carbonero could pave the way for more informed clinical decisions and improved patient outcomes.