Trial shows improved survival for some metastatic CRC patients

Results of a new study announced at the 2023 ASCO Gastrointestinal Cancers Symposium demonstrate that a combination therapy, trifluridine/tipiracil (Lonsurf) plus bevacizumab, has promising activity to increase lifespan in mCRC patients. If approved for use by regulatory authorities, the combination could allow a CRC patient to gain back months — and even years — of their life.

Refractory mCRC is metastatic colorectal cancer that has spread (metastasized) to other parts of the body, such as the liver or lungs, and is resistant to standard treatments. On why this matters, the Colorectal Cancer Alliance’s CEO, Michael Sapienza, said it best on Twitter:

“Of course we want a cure and to extend patients' lives by more than a couple months, that’s why our entire staff dedicates themselves to funding new treatments, but even small advances could mean the world to some patients that want to see their kid reach kindergarten.”

Servier and Taiho Oncology’s study, the SUNLIGHT trial, included 492 patients with refractory mCRC following two chemotherapy regimens. The study aimed to “investigate the efficacy and safety of trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone,” and the most significant findings were:

• A 39% reduction in death risk for patients with refractory mCRC with survival improving to 10.8 months vs. 7.5 months
• A significant improvement in the progression-free survival (PFS) rate — 5.6 months vs. 2.4 months

In a press release, Professor Josep Tabernero, MD, PhD, and Principal Investigator for the SUNLIGHT trial stated the following:

“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 … 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.” 

“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 … 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,” stated Nadia Caussé-Amellal, MD, Head of Global Development, GI Indications, Oncology and Immuno-Oncology Therapeutic Area at Servier.

Fabio Benedetti, MD, Global Chief Medical Officer for Oncology at Taiho Pharmaceutical Co., Ltd. added: “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. 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.”

For more information on the SUNLIGHT study, view Taiho Oncology’s complete Press Release or visit https://clinicaltrials.gov/ct2/show/NCT04737187.