FDA approves Lonsurf plus bevacizumab for metastatic colorectal cancer.- Taiho Oncology and Taiho Pharma

The results from the Phase III SUNLIGHT trial, which were published in the New England Journal of Medicine in May 2023, demonstrated that the combination of Lonsurf plus bevacizumab provided statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) for patients with mCRC following disease progression or intolerance on two prior chemotherapy regimens compared to Lonsurf alone. This was the first Phase III study against an active control in third-line mCRC that demonstrated statistically significant efficacy and safety. Key results include: Median OS was 10.8 months in the Lonsurf plus bevacizumab arm versus 7.5 months in the Lonsurf arm (hazard ratio [HR]: 0.61, 95% confidence interval [CI]: 0.49-0.77, p<0.001). this improvement in os represented a 39% reduction in the risk of death in patients with mcrc. in addition the median pfs was 5.6 months in the lonsurf plus bevacizumab arm versus 2.4 months in the lonsurf arm (hr: 0.44, 95% ci: 0.36-0.54, p><0.001), indicating a 56% relative risk reduction of disease progression. results were consistent across subgroups regardless of age, sex, location of primary disease, number of metastatic sites, kras mutation status, and prior bevacizumab treatment.></0.001),></0.001).>

The OS and PFS benefits of Lonsurf plus bevacizumab were associated with maintenance of quality of life from baseline to cycle 6 and no clinically relevant changes in mean scores were observed in any subdomains for EORTC QLQ-C30 and EuroQol EQ-5D-5L health-related quality of life questionnaires. The combination of Lonsurf plus bevacizumab had a manageable safety profile as was expected based on the known profile of each agent. The most frequent severe treatment emergent adverse events for Lonsurf plus bevacizumab versus Lonsurf alone were neutropenia (43.1% vs 32.1%) and anemia (6.1% vs 11.0%), respectively.