Nageshwara Arvind Dasari, MD, discusses the rationale to evaluate fruquintinib in the ongoing, phase 3 FRESCO-2 trial in patients with metastatic colorectal cancer.
Nageshwara Arvind Dasari, MD, associate professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the rationale to evaluate fruquintinib (Elunate) in the ongoing, phase 3 FRESCO-2 trial (NCT04322539) in patients with metastatic colorectal cancer (mCRC).
Fruquintinib is a potent, highly selective, oral VEGF1/2/3 TKI, says Dasari. The drug was initially developed in China, where it is currently approved to treat patients with mCRC who have been previously treated with fluoropyrimidine, oxaliplatin, and irinotecan.
The regulatory decision, made by the China National Medical Products Administration, was based on findings from the placebo-controlled, phase 3 FRESCO trial, Dasari explains. The pivotal study showed a statistically significant improvement in overall survival and progression-free survival with fruquintinib compared with placebo in previously treated patients with mCRC.
In the United States, the FDA granted a fast track designation to fruquintinib for the treatment of patients with mCRC who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, VEGF-directed therapy, and if RAS wild-type, EGFR-directed therapy. The agent is currently being evaluated in the ongoing FRESCO-2 trial in patients with mCRC from the United States, Europe, and Japan.