Arvind N. Dasari, MD, lead investigator of the FRESCO-2 trial, spoke about the recent approval of fruquintinib for patients with previously treated metastatic colorectal cancer.
The use of fruquintinib (Fruzaqla) has led to improved overall survival in patients with previously treated metastatic colorectal cancer. With fruquintinib’s recent approval by the FDA, and the efficacy results observed in the phase 3 FRESCO-2 trial (NCT04322539), clinicians may now be adjusting their current standard of care, according to Arvind N. Dasari, MD.1,2
In an interview with CancerNetwork prior to the approval of fruquintinib, Dasari along with Cathy Eng, MD, each discussed the potential use of fruquintinib in earlier lines of therapy, and how this regulatory decision opens treatment options for the patient population.
Lead study author Dasari, 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, spoke to the FRESCO-2 trial’s positive safety data and the potential of combining fruquintinib with other therapies.
Eng, David H. Johnson Chair in Surgical and Medical Oncology, professor of medicine, coleader of the Gastrointestinal Cancer Research Program, codirector of gastrointestinal oncology, and director of the Young Adults Program at Vanderbilt-Ingram Cancer Center, mentioned that with the OS and quality of life improvements, patients may now qualify for further treatments and be able to participate in other clinical trials.
Dasari: We’ve been getting a lot of inquiries from patients and providers alike who reviewed the data. I’ve been impressed, and I am eagerly awaiting the potential approval, given the efficacy and the good AE profile that we just discussed. It will be a standard of care for patients with metastatic colorectal cancer. There is a body of evidence from FRESCO and FRESCO-2 showing the activity of this drug in the third-line and as a fourth-line therapy.
Looking beyond just this approval, given that this drug has [impressive] efficacy and is well tolerated, there’s a lot of discussion and excitement around expanding its role into early lines of therapy and combining it with other agents, which has been challenging with regorafenib so far.
Eng: For our patient population with surgically unresectable disease, we have limited treatment. We’ve not had a new drug that’s been approved after trifluridine/tipiracil; it has been almost a decade. We need to find additional treatment options for microsatellite instability [MSI]–stable patients. There’s a lot of interest in the new drugs for KRAS G12C, although that’s a rare patient population, as well as MSI-high patients and HER2 patients, [both of which are] rare patient populations.
For the average MSI-stable patient, we need treatment options. This just gives another opportunity to them, with good quality [and] improved OS. By improving the OS, it improves their own personal quality of life, as well as their capability to potentially participate in another clinical trial.
FDA Approves Encorafenib/Cetuximab Plus mFOLFOX6 for Advanced BRAF V600E+ CRC
December 20th 2024The FDA has granted accelerated approval to encorafenib in combination with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test.