Servier and Taiho Oncology, Inc., today released data from sunshinea global, two-arm, open-label, active-controlled, Phase 3 study evaluating the combination of trifluridine/tipiracil and bevacizumab in adult patients with refractory metastatic colorectal cancer (mCrc), demonstrating that the study met its primary endpoint of overall survival. The data will be presented Jan. 21 at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (Asco GI) in San Francisco.
The study evaluated the efficacy and safety of trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone in patients with refractory metastatic colorectal cancer who were intolerant to or whose cancer was refractory following disease progression to two previous chemotherapy regimens. The results show that the experimental combination resulted in a statistically and clinically significant improvement in survival of 3.3 months compared with trifluridine/tipiracil alone (10.8 months versus 7.5 months). The improved survival represents a 39% reduction in the risk of death in patients with refractory mCrc.
For the secondary endpoint, a statistically significant improvement was observed for the trifluridine/tipiracil plus bevacizumab combination compared with trifluridine/tipiracil alone in progression-free survival (5.6 months versus 2.4 months).
“The prognosis for patients with metastatic colorectal cancer who fail to respond to chemotherapy remains poor, with median survival times typically ranging from 4 to 8 months,” he says. Josep TaberneroMD, PhD, Head of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain, and principal investigator for the Sunlight Study – As colorectal cancer cases are on the rise there is an urgent need for new therapeutic options that can prolong survival in patients with metastatic colorectal cancer in the advanced stages of the disease. In this sense, the results of the study represent an important milestone for patients and for the medical community”.
The side effects – the note details – were those expected on the basis of the known profile of each treatment and were well managed. The proportion of patients experiencing serious adverse events (Grade ≥3) was similar in the trifluridine/tipiracil plus bevacizumab and trifluridine/tipiracil groups: 72.4% versus 69.5%, respectively. Severe adverse events were neutropenia (43.1% versus 32.1%) and anemia (6.1% versus 11.0%), respectively.
“We are very pleased with the results from Sunlight, which demonstrate that trifluridine/tipiracil plus bevacizumab can be an effective and manageable therapy in advanced metastatic colorectal cancer,” he said. Nadia Caussé-AmellalMD, Head of Global Development, GI Indications, Oncology and Immuno-Oncology Therapeutic area, Servier –In the coming months, Servier and Taiho Oncology plan to submit this data to regulatory authorities in order to make this innovative combination available to patients as early as possible.possible”.
“Given the typically poor prognosis and limited options for patients with refractory metastatic colorectal cancer,” he said. Fabio BenedettiMD, Global Chief Medical Officer Oncology, Taiho Pharmaceutical Co., Ltd – there is an urgent need to explore different treatment approaches that may impact the course of the disease for these patients. The results of this study 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.”
Colorectal cancer is the third most common cancer in the world – concludes the note – with almost 1.4 million new cases each year, equal to 10% of global cancer cases. But it is also the second most common cause of cancer mortality, accounting for 881,000 deaths globally in 2018. The worldwide incidence of colorectal cancer is projected to exceed 3 million cases annually by 2040, and is expected to that the number of deaths will rise by more than 70% to 1.6 million a year.
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