Fruquintinib can improve survival outcomes when added to best supportive care in patients with refractory metastatic colorectal cancer (CRC), according to phase 3 results presented at ESMO Congress 2022.

Adding fruquintinib to best supportive care improved progression-free survival (PFS) and overall survival (OS) in the FRESCO-2 trial. 

“These results are consistent with the prior FRESCO trial and support a new, potentially practice-changing, global oral treatment option for patients with metastatic colorectal cancer, enriching the treatment continuum for these patients,” said study presenter Nageshwara Arvind Dasari, MD, of the University of Texas MD Anderson Cancer Center in Houston. 

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FRESCO-2 ( Identifier: NCT04322539) enrolled patients with refractory metastatic CRC who had received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and anti-EGFR therapy (if RAS wild-type). 

The patients were randomly assigned to receive placebo plus best supportive care (n=229) or fruquintinib plus best supportive care (n=458). Fruquintinib was given at 5 mg daily, dosed in a 3 weeks on, 1 week off schedule. Patients were treated until disease progression or unacceptable toxicity.

At baseline, the median age was 64 years in both arms (overall range, 25-86). A majority of patients were men (53.1% in the fruquintinib arm and 60.9% in the placebo arm). The median number of prior treatment lines in the metastatic setting was 5 in both arms (range, 2-16 in the fruquintinib arm; range, 2-12 in the placebo arm). 

The median follow-up was 11.3 months in the fruquintinib arm and 11.2 months in the placebo arm.

The median OS was 7.4 months in the fruquintinib arm and 4.8 months in the placebo arm (hazard ratio [HR], 0.662; 95% CI, 0.549-0.800; P <.001). The median PFS was 3.7 months and 1.8 months, respectively (HR, 0.321; 95% CI, 0.267-0.386; P <.001).

In subgroup analyses, PFS favored the fruquintinib arm in all groups, and OS favored the fruquintinib arm in nearly all groups. The exception in the OS analysis was patients in the “other” race category (vs Asian, African-American, or Caucasian race).

The confirmed overall response rate was 1.5% in the fruquintinib arm and 0% in the placebo arm (P =.059). The disease control rate was 55.5% and 16.1%, respectively (P <.001). 

The safety profile of fruquintinib was consistent with previous findings, according to Dr Dasari. Grade 3 or higher treatment-emergent adverse events (AEs) occurred in 62.7% of patients in the fruquintinib arm and 50.4% of those in the placebo arm. 

The most common grade 3 or higher treatment-emergent AEs in the fruquintinib arm were hypertension (13.6%), asthenia (7.7%), and hand-foot syndrome (6.4%).

The rate of grades 3 or higher treatment-related AEs was 36.0% in the fruquintinib arm and 11.3% in the placebo arm. In the fruquintinib arm, AEs led to dose interruption for 54.2% of patients, dose reduction for 24.1%, discontinuation for 20.4%, and death for 10.5%.

Disclosures: This research was supported by Hutchison Medipharma Limited. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Dasari NA, Lonardi S, Garcia-Carbonero R, et al. FRESCO-2: A global phase III multiregional clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. Presented at ESMO 2022; September 9-13, 2022. Abstract LBA25.