Dr Pedersen on Updates in mCRC Management

Katrina S. Pedersen, MD, MS, associate professor, John T. Milliken Department of Medicine, Division of Oncology, Medical Oncology program leader, cofounder, Young Onset Colorectal Cancer Program, Washington University School of Medicine in St. Louis, Siteman Cancer Center, discusses key updates and FDA approvals from 2023 for the treatment of patients with metastatic colorectal cancer (mCRC).

Patients with mCRC often receive fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, followed by a VEGF inhibitor if it is not contraindicated and an EGFR inhibitor when appropriate, Pedersen says. Historically, patients with refractory mCRC who have received 3 or more prior lines of therapy have had unmet needs, which 2 2023 FDA approvals helped address, Pedersen explains.

The phase 3 SUNLIGHT trial (NCT04737187) evaluated trifluridine-tipiracil (Lonsurf) with or without bevacizumab (Avastin) in patients with refractory mCRC who had received a maximum of 2 prior chemotherapy regimens. This trial demonstrated that trifluridine-tipiracil plus bevacizumab generated progression-free survival (PFS) and overall survival (OS) advantages vs trifluridine-tipiracil alone in this patient population. Pedersen notes that she has observed this clinical benefit with the use of trifluridine-tipiracil plus bevacizumab vs trifluridine-tipiracil alone in her own practice. In August 2023, the FDA approved the combination of trifluridine-tipiracil and bevacizumab for patients with previously treated mCRC based on the findings from SUNLIGHT.

Furthermore, in November 2023, the FDA approved fruquintinib (Fruzaqla) for the treatment of adult patients with previously treated mCRC. Data from the phase 3 FRESCO-2 trial (NCT04322539) supported this regulatory decision and showed that fruquintinib plus best supportive care (BSC) produced PFS and OS benefits vs BSC alone in this patient population, including in patients who had previously received trifluridine-tipiracil and/or regorafenib (Stivarga).

The additions of trifluridine-tipiracil plus bevacizumab, as well as fruquintinib, to the mCRC treatment paradigm have provided a broad range of patients with potential treatment options beyond those approved for biomarker-selected populations, Pedersen concludes.