Pipeline Perspectives: Fruquintinib in Metastatic Colorectal Cancer


Arvind N. Dasari, MD, and Cathy Eng, MD, discuss clinical trial data that may support the FDA approval of fruquintinib in metastatic colorectal cancer, and how it may impact the standard of care.

In this episode of the ONCOLOGY On the Go Podcast, Arvind N. Dasari, MD, and Cathy Eng, MD, speak to data supporting fruquintinib (Elunate), a VEGFR-1, -2, and -3 inhibitor as a potential treatment for patients with metastatic colorectal cancer (CRC).

Dasari is an associate professor in the Department of Gastrointestinal Medical Oncology in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston, Texas. Eng is a David H. Johnson Chair in Surgical and Medical Oncology, a professor of medicine, co-leader of the Gastrointestinal Cancer Research Program, co-director of gastrointestinal oncology, and director of the Young Adults Program at Vanderbilt-Ingram Cancer Center in Nashville, Tennessee, and co-chair of the National Cancer Institute Gastrointestinal Steering Committee.

These experts reviewed data from the phase 3 FRESCO-2 trial (NCT04322539), which assessed the efficacy of fruquintinib compared with placebo among patients with heavily pretreated metastatic, refractory CRC. The median overall survival (OS) in the fruquintinib and placebo arms, respectively, were 7.4 months (95% CI, 6.7-8.2) and 4.8 months (95% CI, 4.0-5.8), meeting the trial’s primary end point (HR, 0.66; 95% CI, 0.55-0.80; P <.0001).1 According to findings from a quality-of-life (QOL) analysis of the FRESCO-2 trial, QOL and time to deterioration appeared to improve in the fruquintinib arm, as well.2

The discussion also focused on how fruquintinib may impact the treatment landscape if it were to receive approval from the FDA in the previously described patient population.

“I’ve been impressed, and I am eagerly awaiting the potential approval, given the efficacy and the good [adverse effect] profile,” Dasari said. “I think [fruquintinib] will be a standard of care for patients with metastatic colorectal cancer.”

Eng also discussed the agent’s potentially implications in select patient subgroups.

“We need to find additional treatment options for microsatellite instability [MSI]–stable patients,” Eng noted. “[Fruquintinib] just gives another opportunity to them, with good [QOL] and improved [OS]. By improving their [OS], it improves their own personal [QOL], as well as their ability to potentially participate in another clinical trial.”

The FDA granted priority review to fruquintinib for patients with previously treated metastatic CRC in May 2023.3 The regulatory agency set a Prescription User Fee Act date of November 30, 2023 for fruquintinib in this indication.

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  1. Dasari A, Lonardi S, Garcia-Carbonero R, et al; FRESCO-2 Study Investigators. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study. Lancet. 2023;402(10395):41-53. doi:10.1016/S0140-6736(23)00772-9
  2. Sobrero AF, Dasari A, Lonardo S, et al. Health-related quality of life (HRQoL) associated with fruquintinib in the global phase 3, placebo-controlled, double-blind FRESCO-2 study. J Clin Oncol. 2023;41(suppl 4):67. doi:10.1200/JCO.2023.41.4_suppl.67
  3. Takeda and HUTCHMED announce new drug application (NDA) for fruquintinib for treatment of previously treated metastatic colorectal cancer granted priority review. News release. Takeda and HUTCHMED. May 25, 2023. Accessed September 20, 2023. bit.ly/43u0FOw
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