Servier and Taiho Oncology Present Overall Survival Data for Trifluridine/Tipiracil (LONSURF®) In Combination With Bevacizumab in Patients With Refractory Metastatic Colorectal Cancer at 2023 ASCO Gastrointestinal Cancers Symposium

Servier and Taiho Oncology Present Overall Survival Data for Trifluridine/Tipiracil (LONSURF^®) In Combination With Bevacizumab in Patients With Refractory Metastatic Colorectal Cancer at 2023 ASCO Gastrointestinal Cancers Symposium

• Patients treated with the investigational combination of trifluridine/tipiracil in combination with bevacizumab in the pivotal Phase 3 SUNLIGHT trial achieved clinically meaningful improvement in overall survival compared to trifluridine/tipiracil alone

• Results demonstrate that trifluridine/tipiracil plus bevacizumab may be an effective and well-tolerated therapy for patients with metastatic colorectal cancer following disease progression on two prior chemotherapy regimens

PARIS, France, and PRINCETON, N.J., January 19, 2023 – Servier and Taiho Oncology, Inc., today announced the release of data from SUNLIGHT, a pivotal Phase 3 global trial evaluating the combination of trifluridine/tipiracil (LONSURF^®) and bevacizumab in adults with refractory metastatic colorectal cancer (mCRC), demonstrating that the trial met its primary endpoint of overall survival (OS). These data will be shared during an oral presentation (Abstract #392020) on January 21, 2023 at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco.

The SUNLIGHT trial investigated the efficacy and safety of trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone in patients with refractory mCRC following disease progression or intolerance on two prior chemotherapy regimens. Results from the main analysis demonstrated that the investigational combination provided a statistically significant and a clinically meaningful improvement in OS of 3.3 months compared to trifluridine/tipiracil alone (10.8 months vs. 7.5 months, hazard ratio [HR]: 0.61, 95% confidence interval [CI]: 0.49-0.77, p<0.001). This improvement in OS represents a 39% reduction in the risk of death in patients with refractory mCRC.

Regarding the key secondary endpoint, there was a statistically significant improvement for the trifluridine/tipiracil plus bevacizumab combination versus trifluridine/tipiracil alone in progression-free survival (PFS) (5.6 months vs. 2.4 months, HR: 0.44, 95% CI: 0.36-0.54, p<0.001).

“The prognosis for metastatic colorectal cancer patients who do not respond to chemotherapy remains poor, with median survival times typically ranging from 4 to 8 months,” said Professor Josep Tabernero, MD, PhD, Head of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain, and Principal Investigator for the SUNLIGHT trial. “Coupled with the fact that cases of colorectal cancer are increasing, there is an urgent need for new treatment options that can extend survival in patients with metastatic colorectal cancer in the later stages of disease. Findings from the SUNLIGHT trial represent an important development, which will be welcomed by the colorectal cancer community.”

Side effects were as expected based on the known profile of each treatment and well managed. The percentage of patients who experienced severe adverse events (Grade ≥3) was similar in the trifluridine/tipiracil plus bevacizumab and trifluridine/tipiracil groups: 72.4% versus 69.5%, respectively. The most frequent severe treatment emergent adverse events for trifluridine/tipiracil plus bevacizumab and trifluridine/tipiracil groups were neutropenia (43.1% versus 32.1%) and anemia (6.1% versus 11.0%), respectively.

“We are delighted by the findings from SUNLIGHT which demonstrate trifluridine/tipiracil plus bevacizumab may be an effective and manageable post-progression therapy in metastatic colorectal cancer,” said Nadia Caussé-Amellal, MD, Head of Global Development, GI Indications, Oncology and Immuno-Oncology Therapeutic Area, Servier. “In the coming months both Servier and Taiho Oncology plan to submit these data to regulatory authorities with a view to bringing this innovative combination to patients as early as possible.”

“Given the typically poor prognosis and limited options for patients with refractory metastatic colorectal cancer, there is a significant need to explore different approaches to treatment that may impact the course of disease for these patients,” said Fabio Benedetti, MD, Global Chief Medical Officer for Oncology, Taiho Pharmaceutical Co., Ltd. “The results of this study potentially further validate the utility of trifluridine/tipiracil in this patient population and demonstrate the potential impact of this combination therapy for the management of advanced disease.”