The FDA approved trifluridine and tipiracil (LONSURF, Taiho Oncology) with bevacizumab, for metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor biological therapy, and if RAS wild-type, an anti-epidermal growth factor receptor therapy. The FDA had previously approved single-agent LONSURF for this indication in September 2015.
Safety and efficacy were evaluated in SUNLIGHT, an international, multicenter, randomized, open-label trial of LONSURF with bevacizumab compared with single-agent LONSURF in 492 patients with mCRC who received a maximum of two prior chemotherapy regimens and demonstrated progressive disease or intolerance to the last regimen.
The primary efficacy outcome measures were overall survival (OS) and progression-free survival (PFS). The trial demonstrated a statistically significant OS improvement in patients randomized to the LONSURF plus bevacizumab arm versus those receiving LONSURF (hazard ratio [HR], 0.61; 95% CI, 0.49-0.77; 1-sided P<0.001). Median OS was 10.8 months in the LONSURF plus bevacizumab arm (95% CI, 9.4-11.8 months) and 7.5 months in the LONSURF arm (95% CI, 6.3-8.6 months). Median PFS was 5.6 months in the LONSURF plus bevacizumab arm (95% CI, 4.5-5.9 months) and 2.4 months in the LONSURF arm (95% CI, 2.1-3.2 months) (HR, 0.44; 95% CI, 0.36-0.54; 1-sided P<0.001).
The most common adverse reactions or laboratory abnormalities for LONSURF with bevacizumab (≥20%) are neutropenia, anemia, thrombocytopenia, fatigue, nausea, increased aspartate transaminase, increased alanine transaminase, increased alkaline phosphatase, decreased sodium, diarrhea, abdominal pain and decreased appetite.
View full prescribing information for LONSURF.
—GEN News Staff
Based on a press release from the FDA.
Originally published by our sister publication Clinical Oncology News