Dr Taieb on the FDA Approval of TAS-102 Plus Bevacizumab in mCRC

Julien Taieb, MD, PhD, head, the Gastroenterology and Gastrointestinal Oncology Department, the Georges Pompidou European Hospital, Université de Paris, discusses the significance of the FDA approval of trifluridine/tipiracil (TAS-102; Lonsurf) plus bevacizumab (Avastin) in patients with pretreated metastatic colorectal cancer (mCRC).

On August 2, 2023, the FDA approved the combination of TAS-102 and bevacizumab in patients with previously treated mCRC. The regulatory decision was based on findings from the phase 3 SUNLIGHT trial (NCT04737187), which included 492 patients who had received up to 2 prior chemotherapy regimens. Overall survival (OS) and progression-free survival (PFS) served as the coprimary end points of the trial.

In this trial, the combination elicited a statistically significant improvement in OS vs TAS-102 alone (HR, 0.61; 95% CI, 0.49-0.77; 1-sided P < .001). The median OS was 10.8 months (95% CI, 9.4-11.8) in patients who received the combination compared with 7.5 months (95% CI, 6.3-8.6) in those who received TAS-102 alone. In addition, the median PFS was 5.6 months (95% CI, 4.5-5.9) in the combination arm vs 2.4 months (95% CI, 2.1-3.2) in the TAS-102 monotherapy arm (HR, 0.44; 95% CI, 0.36-0.54; 1-sided P < .001).

The most common adverse effects or laboratory abnormalities experienced by patients who received the combination were neutropenia, thrombocytopenia, anemia, nausea, fatigue, increased alanine aminotransferase, increased aspartate aminotransferase, decreased sodium, increased alkaline phosphatase, abdominal pain, decreased appetite, and diarrhea.

The FDA approval of TAS-102 plus bevacizumab is important because it demonstrates the validity of combining 2 agents with known efficacy in patients with mCRC, Taieb says. The synergy between TAS-102 and bevacizumab is good and will be practice changing in the United States and potentially worldwide, Taieb emphasizes. Based on the results of the SUNLIGHT trial, this combination can be used as a standard third-line treatment for patients with mCRC, Taieb concludes.