Dr Eng on the Ongoing Investigation of Fruquintinib in Relapsed/Refractory mCRC

Cathy Eng, MD, FACP, FASCO, the David H. Johnson Chair in Surgical and Medical Oncology, co-leader, Gastrointestinal (GI) Cancer Research Program, professor, medicine, Hematology and Oncology, co-director, GI Oncology, Vanderbilt-Ingram Cancer Center; vice-chair, SWOG GI Committee; director, Vanderbilt-Ingram Cancer Center Young Adult Cancers Initiative, discusses the ongoing investigation of fruquintinib (HMPL-013) in patients with relapsed/refractory metastatic colorectal cancer (mCRC).

At the 2023 ASCO Annual Meeting, investigators presented updated data on the use of fruquintinib in patient with mCRC from subgroup analyses of the phase 3 FRESCO-2 trial (NCT04322539). Data from this analysis showed that treatment with fruquintinib and best supportive care (BSC) elicited improvements in overall survival (OS) and progression-free survival vs placebo plus BSC in this patient population, irrespective of the number of prior lines of therapy or types of prior treatment patients had received. Among all 461 patients treated with fruquintinib, the median OS was 7.4 months (95% CI, 6.7-8.2) vs 4.8 months (95% CI, 4.0-5.8) with placebo (n = 230; HR, 0.662; 95% CI, 0.549-0.800; P < .001). Notably, in May 2023, the FDA granted priority review to a new drug application seeking the approval of fruquintinib forthe treatment of patients with previously treated mCRC.

Eng states that this is a current area of anticipation as investigators await final data from the FRESCO-2 trial. She explains that she and other investigators are eagerly awaiting the potential FDA approval of fruquintinib in the relapsed/refractory mCRC patient cohort. This treatmentconsists of a selective oral TKI designed to target VEGF receptors 1, 2, and 3, Eng explains. The data obtained from the trial show an improved OS with fruquintinib, particularly in patients who had received an average of 4 prior lines of therapy, she emphasizes.

Notably, in FRESCO-2, treatment with fruquintinib wasn't limited by number of prior lines of therapy. Given the oral formulation of fruquintinib, investigators are hopeful for its approval, Eng concludes.