Dr García-Carbonero on the Rationale for the FRESCO-2 Trial of Fruquintinib in mCRC

“This [trial] was conducted in a setting with no alternative options for care. Colorectal cancer is one of the most prevalent cancers we have, and even if it's in the fourth line [or beyond], there are still many patients who are very fit, and we don't have options for them. It's a highly unmet medical need.”

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 the rationale for and design of the phase 3 FRESCO-2 trial (NCT04322539) evaluating fruquintinib (Fruzaqla) for the treatment of patients with metastatic colorectal cancer (mCRC).

FRESCO-2 was an international study that enrolled patients with mCRC who had received all standard, approved cytotoxic and targeted therapies and had progressed on or were intolerant to trifluridine/tipiracil (TAS-102; Lonsurf) and/or regorafenib (Stivarga), García-Carbonero detailed. Patients in this disease setting typically have no alternative options for care, she noted. Even in the fourth line and beyond, many patients are fit for treatment; however options for them are limited, she added.

In FRESCO-2, patients were randomly assigned 2:1 to receive oral fruquintinib as a 5 mg capsule or matched placebo once daily on days 1 through 21 of a 28-day cycle, in combination with best supportive care. The primary end point was overall survival.

García-Carbonero presented findings from a subgroup analysis of FRESCO-2 during the 2025 ESMO Gastrointestinal Cancers Congress.

Disclosures: García-Carbonero is on the advisory boards of AAA, Amgen, Astellas, Bayer, BMS, Boehringer Ingelheim, Esteve, GlaxoSmithKline, HUTCHMED, Ipsen, MSD, Novartis-AAA, PharmaMar, Pierre Fabre, Sanofi, Servier, and Takeda. She also received institutional research grants from BMS, MSD, and Pfizer, and is the global primary investigator of investigator-initiated clinical trials for BMS, MSD, and Pfizer. She reported honoraria received by spouse for advisory board or invited speaker roles for AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Genomica, Lilly, MSD, Merck, Novartis, Pfizer, PharmaMar, Roche, Sanofi, Servier, and Takeda.