Servier and Taiho Oncology, Inc., 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.”
About Colorectal Cancer:
Colorectal cancer is the third most common cancer worldwide,1 with nearly 1.4 million people diagnosed with colorectal cancer (CRC) each year,1 equating to 10% of the global cancer cases.1 CRC is the second most common cause of cancer mortality, accounting for 881,000 deaths globally in 2018.2 The worldwide incidence of colorectal cancer is expected to exceed 3 million cases annually by 2040,3 and the number of deaths is predicted to increase by more than 70% to 1.6 million per year.3
About the SUNLIGHT Trial:
SUNLIGHT is a multinational, open-label, active-controlled, two-arm Phase 3 trial to investigate the efficacy and safety of trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone, in patients with refractory mCRC following two chemotherapy regimens. A total of 492 patients were randomly allocated (in a 1:1 ratio) to receive trifluridine/tipiracil plus bevacizumab or trifluridine/tipiracil monotherapy. The primary objective was to demonstrate the superiority of trifluridine/tipiracil plus bevacizumab over trifluridine/tipiracil alone, in terms of OS (primary endpoint). Key secondary objectives were to compare the regimens in terms of progression-free survival (PFS), overall response rate (ORR), disease control rate (DCR) and quality of life (QoL), as well as the safety and tolerability of trifluridine/tipiracil plus bevacizumab in comparison with trifluridine/tipiracil monotherapy.
LONSURF is an oral nucleoside antitumor agent discovered and developed by Taiho Pharmaceutical Co., Ltd. LONSURF consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, resulting in DNA dysfunction and inhibition of cell proliferation.
About Taiho Oncology, Inc.
The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development of orally administered anti-cancer agents and markets these medicines for a range of tumor types in the U.S. Taiho Oncology’s growing pipeline of antimetabolic and selectively targeted anti-cancer agents is led by a world-class clinical development organization. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company’s European and Canadian operations, which are located in Zug, Switzerland and Oakville, Ontario, Canada.
For more information, visit www.taihooncology.com.