Taiho Oncology presented real-world evidence at the ASCO Gastrointestinal Cancers Symposium, demonstrating the benefits of combining LONSURF (trifluridine/tipiracil) with bevacizumab for metastatic colorectal cancer (mCRC) treatment. The studies highlight improved clinical outcomes, including overall survival, treatment duration, and reduced risk of death, particularly in Black patients who are often under-represented in clinical trials.
Enhanced Survival and Treatment Duration with Combination Therapy
One study involving 3,680 adult patients with mCRC compared LONSURF monotherapy to LONSURF plus bevacizumab. The combination therapy showed a significant improvement in median real-world overall survival, with 9.4 months (95% CI: 8.0-10.1) compared to 6.4 months (95% CI: 6.1-6.6; p<0.0001) for LONSURF alone. Furthermore, the adjusted model indicated a significantly decreased risk of death in the combination cohort (HR=0.68; p<0.0001).
The combination regimen also significantly prolonged treatment duration (median 3.5 months [95% CI: 3.3-3.8] vs 2.4 months [95% CI: 2.3-2.6]; p<0.0001) and time to next treatment or death (median 5.0 months [95% CI: 4.6-5.5] vs 3.9 months [95% CI: 3.8-4.1]; p<0.0001; HR=0.73; p<0.0001). The risk of treatment discontinuation was also reduced with the combination (HR=0.65; p<0.0001).
Improved Outcomes for Black Patients with mCRC
Another study focused on 639 Black patients with mCRC, comparing LONSURF alone to LONSURF plus bevacizumab. The combination therapy demonstrated a significant improvement in real-world overall survival (10.8 vs 6.2 months, respectively; p=0.0001). In the adjusted model, participants receiving the combination treatment experienced a significantly lower risk of death (HR=0.45; p<0.0001).
Treatment duration was also significantly prolonged with the combination (3.8 vs 2.4 months, respectively; p<0.0001), and the risk of discontinuation was approximately halved (HR=0.51; p<0.0001).
Clinical Significance and Expert Commentary
"These are the largest real-world studies so far to confirm the findings of the Phase 3 SUNLIGHT trial, which demonstrated that LONSURF paired with bevacizumab, versus LONSURF alone, improved overall survival in patients with treatment-refractory metastatic colorectal cancer," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. He emphasized the importance of these findings for treating Black patients with mCRC, who face higher incidence and mortality rates but are often under-represented in clinical trials.
About LONSURF
LONSURF is an oral nucleoside antitumor agent comprising trifluridine, a thymidine-based nucleoside analog, and tipiracil, a thymidine phosphorylase inhibitor. It is indicated for metastatic colorectal cancer and metastatic gastric or gastroesophageal junction adenocarcinoma under specific prior treatment conditions. Common adverse reactions include anemia, neutropenia, thrombocytopenia, and fatigue. The drug carries warnings and precautions regarding severe myelosuppression and embryo-fetal toxicity.
